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The importance of developing effective pharmacovigilance systems has been fuelled by an increased focus on drug safety and the ever-changing regulatory environment. SMi’s inaugural Pharmacovigilance conference will explore key issues such as inspections, risk management, the use of Independent Data Monitoring Committees and establishing relationships with regulatory bodies. Attend and gain insights that will enhance your management skills and facilitate a more successful drug development strategy.

CNS is one of the largest and fastest growing therapeutic areas of the
pharmaceutical market. The ageing of the baby-boom generation combined
with new and emerging treatments for neurodegenerative disorders, including multiple sclerosis, Alzheimer’s disease and Parkinson’s disease, will lead to further expansion of the neurodegenerative therapies market.

CNS Clinical Trials conference you will examine the strategies offering
the greatest potential for success in CNS drug development, and understand the specifi c
challenges currently faced by developers in this market. In order to enhance productivity
in this fi eld, there has been an increased awareness of the need to align clinical and
preclinical research to facilitate rapid development of new CNS drug therapies. Medical
imaging is increasingly being used as a surrogate endpoint or biomarker of drug effi cacy
in all phases of CNS trials, enabling CNS developers to make more timely decisions.

• Find the right fit supply chain and logistics model for Asia – Learn from the Pharmaceutical and Biotech Power Panel where leaders from various countries sit together and share their solutions
   
• Re-evaluate your client-LSP relationship from a fresh point of view – Learn to form a win-win relationship and leverage on their strengths to realize long-term goals.
   
• Case studies from leading manufacturers – Learn from their mistakes and successes and get valuable tips for the development of your own company’s logistics and supply chain strategy
   
• 2 whole days of unparalleled networking – Meet senior level executives from Asia’s leading pharmaceutical and biotech manufacturers. Share ideas, learn from others and build valuable and lasting partnerships
   
• Focused event – This is guaranteed to be the most relevant and cost-effective conference you will attend all year
  

The recent ECDC/EMEA Technical Report - The bacterial challenge: time to react has highlighted the urgent need for development of new antimicrobial drugs.

"Industry`s pipeline contains very few new antibiotics active against multidrug-resistant bacteria. Without stimulating research and development into new antibiotics, an increasing number of infected patients will be without effective treatment". Bo Aronsson, EMEA.

"A future without effective antibiotics will exacerbate a situation where already at least 25,000 patients in the EU each year die from infections due to multidrug-resistant bacteria. Patients suffering from healthcare-associated infections will be particularly hard hit" Dominique Monnet, ECDC

SMi`s 12th Annual Conference will bring you up to date with new and emerging products in the antimicrobials market, with a particular focus on antibacterials and antifungals and allow you to learn from and network with some of the leading individuals and organisations in this ever important area.

Key topics include:

• A global update on emerging antibiotic resistant pathogens 
• Developments in the emerging global challenge of bacterial multi-drug resistance 
• Tackling resistance in gram-negative bacteria 
• Forming strategic alliances with large pharma to develop new antibacterials 
• New approaches to fungal and protozoal infections  
• Insights into novel therapies for overcoming resistance

Pharmacovigilance is becoming ever more critical for pharmaceutical companies as the public and legislative pressure to ensure drug safety increases every day. Effective implementation of pharmacovigilance can aid drug development, benefit rational communication and sound public understanding, taking emerging regulatory policies worldwide into account. The challenge to manage adverse events in an optimal and efficient way and, at the same time, adhere to regulatory requirements will demand a great emphasis on pharmacovigilance in the near future.

5th Annual Pharmacovigilance conference will underpin processes and developments on many different elements including the regulatory and legislative framework, risk management, PSUR, live licensing, in drug safety and surveillance. With succinct themes, interactive sessions by key opinion leaders, our conference will bring latest insights, integrated strategies and best practices in pharmacovigilance.

This one day meeting is designed to be an introduction to the topic of the electronic Common Technical Document (eCTD). 

The day is a mix of presentations on the subject, including detail about the specification itself and practical considerations for implementing the eCTD in your organisation. 

Topics to be covered include:-

• Introduction and overview of the eCTD
• What are the main components of the eCTD
• The ICH and European eCTD specifications
• Transitioning from paper submissions to the eCTD
• Considerations when selecting tools for the eCTD
• Process changes for the eCTD
• Practical experiences of submitting eCTDs

This course has been designed for persons with at least 2 years worth of knowledge in Drug Safety. The course will provide a very comprehensive and yet practical assessment of the main Regulations required to produce a compliant reporting Company.

This course would be of maximum benefit to those safety professionals who are working both in the Clinical and Post-Marketing Safety arena. The course covers very diverse activities within the Safety Department and would be advantageous to those who have either multifunction responsibilities or Medical Directors who manage teams in the various disciplines.

Key Topics to be covered:

• Due Diligence
• Training for Drug Safety - Reporting Duties
• Audits and Expectations
• Compliance and Drug Safety
• Independent Data Monitoring Boards
• Product Safety Reviews – Purpose and Function
• Safety Reporting in Licensing Agreements
• Developing Company Core Safety Information – CIOMS III
• PSURs
• The EU Clinical Trial Directive
• Risk/Benefit Determinations
• CIOMS V
• Crisis Management

Topics

• Critical Regulatory Requirements for a Stability Program
• Regulatory Guidelines Governing Stability Testing Operations
• ICH Guidelines for Stability: USA, EU, Japan, and Rest of World (ROW), A Detailed Review
• Stability Role in Drug Development Process
• Stability Documentation Requirements
• Stability Study for Early Drug Development
• Testing Considerations     
• Increasing the Efficiency of Stability Testing Studies
• Ongoing Stability Testing - Requirements, Cost Effective Solutions and Potential Pitfalls
• The Methodology for Calculating Stability and Release limits
• Estimating Shelf Life and Post-licensure Stability Studies
• Investigation of OOS and OOT Stability Results
• Outsourcing Stability Studies - Achieving Successful Relationships and Outcomes
• Implementation of a Flexible cGMP Complaint Stability Program for Phase I - III Studies
• Stability Chambers
• Temperature Monitoring During Transportation and Storage
• Assessing the Stability of Amorphous or Semi-Amorphous Materials
• Integrating Laboratory Information Management Systems to Optimize Stability Programs
• Forced Degradation Studies of API’s and Drug Products
• Stress Testing of APIs and Drug Products
• Overcoming Key Challenges in Stability Testing for Generics
• Current Practices in Annual Vaccine Stability Studies

Patient recruitment and retention are critical to drug development programs. Patient recruitment if not adequately planned for can extend development time-lines by a number of years. Retention of patients throughout the life of a clinical trial is essential in order have complete data sets for analysis and subsequent filings.  

Key topic include:

The bi-annual International Geneva/Springfield Symposium on Advances in Alzheimer Therapy distinguishes itself from other scientific meetings of this kind for two main characteristics.

First, it`s the only international meeting that focuses entirely on the pharmacological therapy of Alzheimer Disease with particular emphasis on the discovery of new drugs. The theme includes: drug development at different preclinical and clinical stages, results of clinical trials and pharmaco-economics implications.

Second, the meeting is organized jointly by an American ( Southern Illinois University, School of Medicine in Springfield Illinois, USA ) and a European ( University of Geneva, Medical School Dept. of Rehabilitation and Geriatrics ) University

Hospital pharmacy is the health care service, which comprises the art, practice, and profession of choosing, preparing, storing, compounding, and dispensing medicines and medical devices, advising healthcare professionals and patients on their safe, effective and efficient use.

Hospital pharmacy is a specialised field of pharmacy which forms an integrated part of patient health care in a health facility.

Hospital pharmacy is the profession that strives to continuously maintain and improve the medication management and pharmaceutical care of patients to the highest standards in a hospital setting.

Hospital pharmacists provide services to patients and health care professionals in hospitals.

Two days of training which can be booked individually or together. Discount available if booked with REGULATORY AFFAIRS FOR SUPPORT STAFF ~ PART 2 on 26th March 2010

Topics to be covered:

• Learn about the Drug Development Process – from Drug Discovery to Product Launch and Beyond
• Understand the background of European Law – Regulations, Directives, etc.
• Discover where you can find information on Regulatory Affairs, Approvals, Withdrawals, etc.
• What is the Centralised Procedure?
• Understand the EU Clinical Trial Directive
• How to Seek Scientific Advice in Europe
• What is the Common Technical Document

Two days of training which can be booked individually or together. Discount available if booked with REGULATORY AFFAIRS FOR SUPPORT STAFF ~ PART 1 on 25th March 2010

Topics to be covered:

• How to apply for a Marketing Authorisation in the EU
• Key Aspects of Safety Reporting
• Pharmacovigilance and GCP Inspections
• Managing Product Labelling
• Discuss Licence Variations
• Understand Parallel Imports & Generic Applications
• Managing a Regulatory Affairs Department

The Development of Regulatory Authorities and of the Process of Post Marketing Surveillance in developing countries Vaccination is a very powerful public health tool for preventing many infectious diseases. The protection obtained in vaccination programs can be measured both at individual level and community level. As for drugs, the vaccines need to be registered and licensed by regulatory and health authorities before vaccination recommendations. The evaluation of the vaccine to be licensed is focusing on 4 major aspects: quality, efficacy, safety and post-marketing surveillance. As the last item is implemented since several years in the Western Countries, the Developing Countries are still working on better pharmacovigilance systems. Recently risk management plans have been implemented both in Europe and North America, significantly increasing the safety activities in a pro-active manner.

Manufacturers have to meet the requirements set by regulatory agencies for both registration of vaccines and post-marketing surveillance. Although most developed countries have a national regulatory authority, with two forefront agencies (EMEA for EU countries and FDA for the USA), important differences exist between different regions of the world regarding the requirements for registration of vaccines and pharmaco-vigilance. Developing countries have a broad range of regulations regarding both the registration and the pharmaco-vigilance systems.

The objective of this meeting is to bring together experts from the regulatory agencies, the vaccines manufacturers and vaccines program (EPI) from both Developed and Low to Middle Income Countries (LMIC), aiming at:

• Reviewing[n1] the present status on the role of regulatory agencies in relation to the benefit-risk ratio of vaccines (clinical trials and pharmaco-vigilance) in both western and low to middle income countries; with a discussion on how vaccines are evaluated on the different parts of the dossier: Quality, Non-Clinical, Efficacy, Safety and Risk Management Plan.
• Discussing the response of vaccine manufacturers to increasing demands of regulatory agencies in terms of vaccines safety and effectiveness. Indeed once a vaccine is licensed, it is extremely important to measure and follow how the vaccine will behave in real world conditions.
• Reviewing the international and regional actions for developing/strengthening regulatory authorities in Low to Middle Income Countries and the involvement of the WHO, western regulatory agencies and the manufacturers.
• Trying to identify the gaps in the regulatory systems in low to middle income countries.
• Trying to identify further actions to be taken to help filling these gaps.

Regenerative medicine is set to revolutionise healthcare as stem cell, tissue engineering, gene therapy and materials science come together to transform patient treatment. Bringing you the latest in translational applications from leading experts, don`t miss this exceptional showcase of medical innovations in this fast-moving field.

By attending this conference you will gain the latest insights into:
• The economic future of the global regenerative medicine market and acquiring venture capital
• The use of stem cell therapies in type 1 diabetes
• Small molecule drugs to stimulate neurogenesis and neuroprotection in Parkinson’s disease
• The use of direct stem cell therapies in cardiovascular diseases
• The use of direct stem cell therapies in wound healing
• The use of direct stem cell therapies in bone remodelling
• Gene therapy for retinal degeneration
• Scaling-up in the lab
• Scaling up in manufacturing
• Clinical trials for novel therapies
• How to commercialise your product
• Overcoming patent, legal and regulatory hurdles

Streamline your Supply Chain Operations Mitigate Security and Product Integrity Risks Maximise your Stakeholder Buy-In

What Pharma Logistics 2010 will offer you:

Pharma Logistics 2010 will offer those charged with the responsibility of carrying out and managing logistical tasks a chance to hear best practice processes and strategies from a domestic and a regional level.

Having spoken to the industries leading Operations / Supply Chain / Logistics Pharma executives both locally and abroad, it became clear that I need to cover a wide range of topics featuring both international and domestics presentations.

Pharma Logistics 2010 is you purpose built 2 day event designed to strengthen your supply chain operations. As you know, a robust regional supply chain is paramount to the company’s success while at the same time minimising risk and cost.
Pharma Logistics 2010 will deliver a range of case studies that will discuss different aspects of logistical operations in pharmaceuticals, including:

Effective supply chain management is essential to successfully service the front end of the organisation…How effective is yours?

Pre-filled syringes and injection devices are now regarded as the delivery method of choice for a wide range of parental products. According to industry research, the current market for pre-filled syringes is expected to reach 2.5 billion units by 2010. The growth rate is to be expected to remain at a high level of more than 10% annually due to a number of factors such as greater medication safety and increased convenience from using a pre-fillable device. However, there are some challenges and potential threats to syringe and needle supply manufacturers.

By attending this conference, you will: 
• Understand today`s market, how it has evolved and what to expect in the future
• Hear about pre-filled syringes for biotech products and auto injector devices
• Understand pre-filled syringe processing with RABS, Isolators, E-beam & Alternatives
• Examine factors and recent developments in processing syringe nests
• Analyse elastometric pre-fillable syringe component
• Evaluate the impact of economic, technology, and regulatory factors
• Develop new strategies to remain competitive
• See manufacturers showcase some of their products

Pharmaceutical packaging and labelling is considered an essential aspect of the product. The role of packaging and labelling has increased considerably and constantly advancing over the last few decades. This area has been experiencing emerging regulatory issues and stringent restraints.

Key Benefits:

• Stay up-to-date on the latest innovations in packaging and labelling
• Learn how can you turn a cost and hygiene factor into a commercial benefit?
• Examine new strategies in fighting counterfeiting
• Gain knowledge about legislation and existing models – EU, USA, Greece, Italy, Belgium, Turkey
• Find out about the supply chain security and compliance
• Seize this opportunity to network with leaders from pharma-biotech, healthcare and regulatory agencies

5th ANNIVERSARY CENTRAL ASIAN INTERNATIONAL PHARMACEUTICAL EXHIBITION “APTEKA EXPO 2010”

American Conference Institute’s 8th Expert Regulatory Guide to Advertising, eMarketing and Promotions for the Pharmaceutical Industry will provide the guidance that is greatly needed by the life sciences industry at a time of transition. Companies do not want to miss out on the great opportunities presented by the huge popularity of social media, and other web sites where products may be discussed and promoted. The use of these new promotional channels, however, presents complex compliance questions and risks potential exposure to government inquiry.

With the FDA handing out warning letters recently “like candy,” it is essential to have sophisticated knowledge of the applicable regulatory requirements and specifi c “red fl ags” that you need to watch out for. The expert faculty at ACI’s timely conference, including in-house experts from 14 different companies, will directly address how to ensure that you are using the best available practices to operate safely in your advertising and promotional activities (in both traditional and nontraditional areas). You will be able to compare how your peers at other companies are applying the current rules in practice to different types of advertising and promotions. The faculty includes government and regulatory specialists who focus on the intersection between FDA law and marketing issues, and who are resolving these challenges daily. The program will provide up to the minute updates on state and federal legislation, regulatory guidance, and recent enforcement trends that are vital to understand in order to control your risks when mounting successful promotional programs today.

Special focus will be placed on particular areas that companies are seeking guidance on, including:

• How to ensure proper disclosure of risk information in a small ad on the internet
• Safely informing consumers about products on web sites, and correcting false information
• Anticipating what types of conduct might lead to allegations of off-label promotion
• Making use of athletes and other celebrities as spokespeople making product testimonials
• Preparing effectively for potential outcomes from the recent FDA meeting in Washington on Internet marketing

Medical devices manufacturers require a more rigorous and strategic approach to safeguard product prices and prevent competition. Innovative manufacturers that have integrated their pricing and product strategies will achieve exceptional growth and profitability in this changing environment.

Take advantage of the networking opportunities and gain insights on:
• Evaluation of reimbursement mechanisms in the five major EU markets (France, Italy, Spain, Germany and UK)
• Opportunities to obtain higher reimbursement for innovative medical devices
• NICE health technology and device appraisals: Processes and people
• Developing a reimbursement strategy for introducing an innovative medical device into a prospective payment based system (DRG)
• Combining reimbursement and clinical expertise to realise clinical utility targets
• Market Access and funding for medical devices in Central Eastern Europe
• Maximising the value of CED from a device manufacturer perspective
• Assigning monetary value to innovative medical devices and diagnostic technologies

Definitive cures for asthma and COPD remain elusive but products developed to treat the symptoms provide one of the highest sources of revenue for the pharmaceutical industry. SMi’s sixth annual Asthma & COPD conference will present attendees with an exceptional line-up of speakers and an unrivalled forum for discussion and debate.

There will be an opportunity to hear about new research involving the use of bronchodilators and kinase-inhibitors as well as antibody based biologics. Presentations will also cover topics such as new therapeutic targets in asthma and COPD and optimising respiratory clinical trial data.

• Hear about novel endpoints in COPD clinical trials
• Explore the application of in vitro cell models in drug development
• Learn about the use of the use of protein kinases as drug targets
• Discuss methods for candidate drug selection and risk management
• Network with industry associates and share experiences

Having run highly successful CSV conferences in the past, in 2010 SMi are revisiting the issue of Computer Systems Validation in the Pharmaceutical Industry to look at whether the pharmaceutical industry could change its attitude towards CSV, so that it is done sensible, effectively and practically.

Taking place in London, UK, this conference will focus on a wide range of issues withing the CSV arena, including the regulatory aspects to CSV - whether the current guidelines need expanding, reinterpreting or rewriting - CSV in an R&D context, the need for a risk-based approach to CSV, the respective benefits of doing CSV in-house or contracting it out, and developing a `bigger picture` approach to CSV.

Questions examined during the conference will include: what is the role of QA departments?  How much CSV is enough?  Does CSV hamper clinical R&D?  Should all CSV be risk-based in analysis?  Should the industry use a consortium approach to vendor-CSV audit?  Are consultants too widely used - would CSV be done better in-house?  What are the CSV implications for mergers?  How to develop a quality model?

Attend this event to discover how computer systems validation does not have to be difficult, time-consuming and costly, and to learn how to plan for better implementation of a CSV programme.

Bridging the Gap in Pharmacoeconomics and Outcomes Research between Researchers,Clinicians, Policy Makers, Healthcare Authorities and Industry in Central and Eastern Europe - Pharmacoeconomics in Health Systems in Transition.

An inspection conducted by the US FDA is a very important milestone in any pharmaceutical company`s lifecycle.  A successful inspection opens the door, or retains access to one of the world`s most lucrative markets.  When it is unsuccessful the inspection can seriously damage the reputation of individuals within the company and the company itself.  Penalties such as Warning Letters and Import Restrictions can easily be applied.  Further action such as severe fines and Consent decrees can follow; these measures can seriously affect the viability of the company.  FDA look for a culture of Quality that is led from the very top of the company.
 
The format of this course is a mix of classroom activity and practical workshops to prepare you for different types of FDA inspections and the challenges they present.  The course is directed toward personnel from, development, manufacture, quality and/or regulatory compliance who are responsible for FDA inspectable activity relating to the manufacture and quality control of pharmaceutical products for the USA market.
 
THIS COURSE WILL PROVIDE:

• Background to FDA`s Inspection authority
• The background to changing FDA approaches
• The knowledge to help you prepare to successfully host an FDA inspection
• Common FDA inspection target areas/systems
• Running an inspection ready room
• Help in interpreting what a Form 483 actually states and how to formulate your response

A review of the EU Guidance on the SmPC considering important changes in the Guidance, as well as discussion on the Clinical, Pre-clinical and Pharmaceutical Issues in creating or amending the SmPC (with special emphasis on the anticipated problem areas)

The other important issue regarding the SmPC is EU harmonisation, and this meeting will consider procedures for harmonisation emphasising articles 29 and 30, and outline experience to date from both a regulatory and industry point of view.

TOPICS TO BE COVERED AT DURING THIS MEETING:

• EU SmPC: Significant and interesting changes in the Guidance
• Industry view of changes to the SmPC guidance
• EU Harmonisation of the SmPC: articles 29 and 30 harmonisation
• Industry view of harmonisation
• The SmPC and the Package Leaflet

SMi`s industry-leading High Throughput Screening conference returns for its sixth year.  The theme of this year`s conference will be how to lead HTS down an intelligent route towards lead generation.

Taking place in London, UK, this conference will look at a wide range of issues within the HTS arena under several `topic umbrellas`.  The State of the Industry will look at the best of HTS now, outsourcing and hit-to-lead bottlenecks.  Focussing HTS will investigate methods to increase the quality of the leads generated.  There will be in-depth studies into In-Silico Screening and GPCRs, and finally, a look to the future in New Screening Technologies.

Questions examined during the conference will include: how successful is HTS now?  Is outsourcing worthwhile economically?  What are the IP issues?  Can intelligent research outperform HTS?  Does iterative screening hold the key to obtaining high quality leads?  How can we redesign the HTS framework?  Do we rely on established assays too much?  Can virtual screening ever replace HTS as the standard lead generator?  How can HTS be used successfully in harnessing the power of GPCRs?  What is the potential for biophysical tools to be used in screening?

Attend this event to discover how High Throughput Screening can be made more intelligent, more focussed and more beneficial in drug discovery

Immunogenicity is a significant area of discussion in the pharmaceutical and biotech industry with new strategies and practices being developed, also it is a primary safety concern for regulators.

Key Benefits:

• Examine the efficient methods of immunogenicity testing
• Assess immunogenicity risk assessment strategies
• Evaluate the impact of immunogenic responses on efficacy and safety
• Analyse the strategies for pre-clinical immunogenicity testing
• Discover how to address immunogenicity issues related to formulation
• Gain an insight into the impact of anti-drug IgE antibody testing
• Hear case study updates from top biopharmaceuticals on immunogenicity
• Understand immunogenicity from a practical physician`s perspective

The controlled release of a pharmaceutical active can be a vital tool in ensuring the safety and efficacy of a new or existing treatment. Developing new methods of controlled release is important to prolong the duration of action, can help to minimise adverse reactions and maximise efficacy as well as being an effective way of increasing a drug`s lifespan.

SMi`s 7th Controlled Release conference will provide you with the latest updates in this area, including controlled release development strategies, practical issues in developing controlled release therapeutics and information on the latest advances in delivery methods.

Key topics to be addressed at the conference include:

• The application of advanced science & technology to develop controlled release dosage forms
• Controlled Release - the role of intellectual property in maintaining and growing market share
• Controlled release in chronic diseases
• Overcoming the blood brain barrier
• Modified release multiparticulates 
• Hot melt extrusion: How to enhance dissolution rate by solid dispersions
• Developing novel inhaled controlled release therapeutics 

This year’s distinguished faculty of legal and industry experts from Canada and the U.S. will provide you with current, in-depth information on the latest legal developments and regulatory changes in pharmaceutical and biotechnology patents.

Session highlights include:

• Case law on selection patents sound prediction: what is required?
• File histories: alive and well in PM(NOC) litigation?
• Canada’s pharmaceutical price review regime and trends
• Settling pharma patent cases: when to, how to and obstacles to
• Improving access to medicines with a pharmaceutical patent pool: legal/business and antitrust considerations
• South of the border: the year in review
• Strategies in pharma patent litigation
• Ground breaking decisions: how the landscape has changed for 2010
• Canadian duty of good faith vs. the U.S.: where the law is headed

The worldwide generics industry has seen strong growth in recent times as the demand for affordable treatment has increased worldwide. In addition to this, numerous branded-drug patent expirations, the prospect of generic biotechnology drugs and a favourable regulatory environment is providing a huge opportunity for the sector to expand further.

Join us for SMi`s 13^th annual Generics, Super-Generics and Patent Strategies and discover the future of the generics market. Hear experts in the field discuss the latest patent strategies, regulatory updates and growth strategies that will be key to the future of the industry.

Key topics include:

• Examine the legal framework and litigation mechanics in both the EU and US 
• Latest legislative and regulatory updates in generics and biosimilars
• Identify key growth areas and methods to take advantage of these
• M&A activities and their implications
• New business models
• Emerging markets
• R&D in generics

During the period 2008-2013, the most important development in influenza vaccines, will be the diversification of influenza manufacturing. New cell-based technologies will be used, and eventually replace, existing egg-based manufacturing methods. Many cell-culture vaccines are being developed under grants from the US government.

Key themes:
• An overview of cell culture technology: The latest developments on cell-culture based vaccine production
• Cell line selection and development
• Mammalian cell culture processes for large scale operation
• Glycan analysis in cell culture-based influenza vaccine production
• Influence of host cell line and virus strain on the glycosylation pattern of viral Haemagglutinin
• Bulk Production, microcarrier cultures and free-cell suspension cultures
• Downstream processing parameters for purification, filling, and packaging of the cell culture based vaccines
• Flow cytometric monitoring of influenza virus infection
• Validation of cell culture based processes & qualification of associated equipment and facility
• Analysing ventures of global vaccines manufacturers in the developing world
• Regulatory issues associated with the development of cell-based influenza vaccine

Global transport of temperature-sensitive drugs and clinical materials presents a tremendous challenge for pharmaceutical and biotechnology companies. With the overwhelming complexity of assuring product integrity throughout the entire distribution chain, the increased scrutiny placed on in-transit temperature control and monitoring and huge costs that can be potentially incurred due to temperature excursions, it is more important than ever to get cold chain management right the first time.

Pharma IQ’s 3rd Annual Pharmaceutical Cold Chain Management Asia is the only event of its kind in the region and will look at Asia-specific cold chain management issues.

The 3rd Annual Pharmaceutical Cold Chain Management Asia provides the largest and most comprehensive forum for Asian pharmaceutical and biotechnology professionals involved in the temperature-controlled supply chain. Attendees will be able to network with and learn from other organizations who face similar challenges in monitoring, controlling, and maintaining the temperature of products throughout the supply chain – from manufacturing to warehousing, wholesalers, pharmacies, hospitals, and ultimately to the end user.

The 3rd Annual Pharmaceutical Cold Chain Management Asia will feature revolutionary content designed to advance temperature-sensitive supply chain practices through technical case studies and panel discussions.

With the high costs of development for a new drug, no company can afford to further increase costs through inefficiencies in the clinical trial supply chain.  As an attempt is made to reduce expenses through conducting clinical trials in the emerging markets of Asia, India, South America and Eastern Europe there is an increasing need to ensure that your logistics procedures are as efficient and cost effective as possible.

SMi`s 4th annual Clinical Trial Logistics conference will address your concerns and provide you with the tools to safely and efficiently resolve your clinical trials logistical challenges on a global scale. This conference will also analyse the latest developments in labelling, packaging, inventory management, security, forecasting, partnering and outsourcing.

In recent years there has been an explosive growth in biological data which has to be managed and stored for various purposes. Bioinformatics plays a vital role in developing new tools for managing and analysing the data. The bioinformatics market is driven by the need of pharmaceutical and biotechnology companies to increase the efficiency of their drug-discovery and development efforts. The focus is now on target validation for translating genomic information into knowledge for developing therapeutics, proteomics and the changing trends in the drug discovery procedures.

Key Benefits:
• Examine DNA and RNA structure, function and sequence analysis
• Assess the challenges of data integration
• Evaluate the advantages of proteomic analysis to the drug industry
• Analyse the future regulatory environment
• Receive an update on the global informatics software market
• Gain an insight into the bioinformatics application in drug discovery
• Be part of a unique networking opportunity

The aim of this seminar is to provide an understanding of the nature of regulatory affairs in South Africa, Anglophone Africa as well as Francophone Africa.  The focus will be on all major markets as well as the smaller markets in general and will in particular, give advice on the timely compilation of the registration ‘packaging’.  All aspects of product and where appropriate, company registration will be discussed with reference to regulations and guidelines, in particular recent changes to these.  Both national and international trends will be referred to.

Who Should Attend

A comprehensive course designed for all personnel in the Pharmaceutical Industry new to or already dealing with Regulatory Affairs in Africa including South Africa.

Topics to be covered at this meeting:

• The Markets
• The Development of Drug Control
• Company and Product Registration
• Compilation of the Dossiers
• Regulatory Submission Strategy
• Agency Assessment
• Recent Developments in South Africa
• Interactive Workshop: Putting Learning into Practice
• Harmonisation and Co-operation Initiatives in Africa
• General Country Specific Discussion

eCTD is an interface for the pharmaceutical industry to agency transfer of regulatory information. In July 2009, the EMEA have made it clear that paper and other electronic formats will be an exception to the general e-CTD format recommended for any application. As it is not limited to the transfer of information it also applies to the creation, review, life cycle management and archival of electronic submission. Hence, drug manufacturers must consider new methodologies and adapt their organisation to change.

By attending this conference, you will:
• Discuss emerging trends in electronic submissions in the US & Europe, Filing CTDformatted 
• Identify challenges and benefits of transitioning to eCTD
• Hear the various methods of submitting electronic submissions to global health authorities
• Learn how to manage the lifecycle of an eCTD
• Understand if outsourcing is a rapid, cost-effective option for electronic submissions
• Recognise the vital role of good document management and best business practices in the overall process of preparing the eCTD
• Describe the role of eCTD standards and analysing their impact to the development/delivery process.

PABME is the leading pharmaceutical and biotechnology event in the region. The event has just successfully completed its 2nd edition with exhibitors from 25 countries showcasing their products and the latest technologies. PABME showcases a wide spectrum of products and services to cater to all businesses associated with the pharmaceutical and biotechnology industry and offer them an opportunity to find new business contacts, suppliers, distributors, see what the competition has on offer and to gain recognition worldwide. If you are involved in the industry, this is a `must attend` event. Supported by multi-topic conferences, in line with IIR`s continuous education directive, this showcase offers an `East meets West` networking opportunity specific to the industry. Now with the inclusion of Arab Health`s PHARMA, an event not to be missed by industry professionals.

With more than 25 products in clinical use worldwide, including eight blockbusters, monoclonal antibodies have arrived as therapeutics. The global monoclonal antibodies market, worth $41bn in 2010, remains one of the most exciting and promising areas within the world pharmaceutical market today.

By attending this conference, you will gain key insights into the hottest topics and main drivers in mAb research and development today, including:
• Oligonucleotide, and new scaffold and next generation technologies
• The importance of isotyping in preclinical modelling
• New data from clinical trials for conjugated and unconjugated therapies
• Identifying and validating cell-surface antigens for antibody targeting
• Prospects for fragment monoclonal antibodies
• Overcoming immune reactions to improve clinical applications of antibody therapeutics
• Reducing inflammation and tissue damage in central nervous system diseases
• Market impact and post-marketing issues
• Prospects for inhibiting angiogenesis
• Perspectives on antibody process development including sharing IP, or implementing and licensing commercial process technologies
• Challenges facing implementation of anti-solid/liquid tumour therapies 

Master the fundamentals of pricing for government payor programs

Finding expert information on government pricing can often prove more difficult than pricing itself. To fill this void, ACI has created Rx Drug Pricing Boot Camp. Now in its fourth year, this program provides drug manufacturers, PBMs, plans, and pharmacies with the critical information they need to effectively and efficiently manage government pricing. ACI’s Boot Camp is the training program you need to ensure that your pricing group and other related departments are well-versed in critical pricing concepts and methodologies. No other conference breaks down the fundamentals of prescription drug pricing in such an easy-to-understand and comprehensive format.

With health care reform a top priority for the new administration, it is more important than ever to have a strong grasp of pricing fundamentals so you can understand how proposed changes will affect your daily operations and overall pricing strategy. This comprehensive course will enhance your understanding of complicated pricing calculations and will bring you up to speed on the latest in government pharmaceutical pricing.

In addition to intensive training in core pricing methodologies and concepts, ACI’s Rx Drug Pricing Boot Camp, also provides the opportunity to network with fellow pricing colleagues. With 80% of attendees coming from drug manufacturers, PBMs, plans and pharmacies, this is the perfect opportunity to find out what other companies are struggling with and how they are overcoming those struggles.

Safety pharmacology emerged a decade ago because drug failures were poorly anticipated. The terfenadine case highlighted the danger (and prediction difficulty) of rare but lethal adverse events. In the last ten years there has been much progress. New regulations have evolved. Mechanisms of drug adverse effects have been elucidated. Industrial safety pharmacology has emerged as the life partner of drug discovery.

Nevertheless, there remain important unresolved questions. For example, from an industry perspective, how much safety pharmacology should a company provide for regulatory consideration when seeking new use approval for a novel therapeutic? From the regulator perspective, how much information is required from industry to permit a decision? From the academic perspective, how can basic science be used to inform the decision making process? From all perspectives, how do we know when models and methods have been validated?

With the emergence of biologics, and the application of new approaches and techniques for drug discovery, the need for clarity, transparency and accountability has grown. It is the expense of time, resources and effort that require attrition – not drug discovery. Therefore it is essential that the three corners of the ‘safety triangle’ can see one another, recognise one another’s position, communicate and interact.

The purpose of this meeting therefore is to highlight the gaps between industry, academia and regulators and identify ways of bridging them. To do so, participants are encouraged to consider ways of overcoming the three main obstacles to progress: the restrictions of economics, the clarity of regulatory guidance and the limits of scientific knowledge.

Effective forced degradation strategies assessing the stability in early phase of drug development is vital for the long term success of any drug. Analytical techniques are very sensitive to support very low levels of detection (LOD) and quantitation (LOQ). In recent years, analytical technologies have advanced so much that the detection of impurities at very low levels has become significantly less complex, though it still poses numerous challenges.

Learn, discuss and gain knowledge on:
• Forced degradation studies: groundwork and practical aspects
• Forced degradation concepts for small and big molecules
• Drug degradation chemistry within drug discovery
• Bioassays for assessing degradation
• Monitoring and evaluation of single amino acid modifications of therapeutic monoclonal antibodies
• Pre-formulation of proteins by high-throughput techniques
• Rapid and robust excipient selection during formulation development
• Comparing two different excipient screening approaches for the same drug
• Integrated approach to detect and quantify genotoxic impurities in APIs
• Quality by Design (QbD) application to GTI control strategy
• In silico Prediction of forced degradation
• Regulatory perspectives on drug degradation and stress testing

CINP was established in 1957 in Zurich and had its first international congress in Rome in 1958. At CINP meetings clinicians hear about the latest research advances and new treatments whilst researchers hear about new clinical needs and problems. CINP facilitates training of psychiatrists in quantitative rating scales and ethical research methodology to enhance manpower for clinical trials worldwide. The CINP maintains partnership and cooperation with the worldwide pharmaceutical industry while at the same time welcoming critical thinking about the limits of psychopharmacology, ethical issues in psychopharmacology research, and early warning systems about side effects of psychopharmacology treatments.

CINP is a genuinely international organisation. Its executive committee and council include leadership from around the world in psychopharmacology. Its membership includes psychiatrists, pharmacologists and other basic scientists, and research psychologists. In our rapidly globalizing world CINP allows exchange of experience and researchmethodology among clinicians and researchers from the four corners of the globe. Its major congresses have taken place all over the world. Furthermore it has regional groups which are active worldwide. These regional groups organise regional meetings, workshops and other educational activities and help generally support psychopharmacology in their regions.

CINP has an official journal, the International Journal of Neuropsychopharmacology (IJNP). This has become one of the essential journals in our field of research and it continues to grow in both size and importance. Its impact factor has shown a steady increase. CINP meetings are open to all interested professionals. CINP membership is awarded to professionals active in the field as recognition of accomplishment after application to and approval by the membership committee.

SMi ran its first conference on pain therapeutics in 2001, and has run a highly successful conference on this topic every year since.  In 2010, our industry-leading Pain Therapeutics conference returns for its tenth year, and will build on the knowledge-base and reputation that SMi has in this area to deliver the most interesting and informative conference yet.

Taking place in London, UK, this conference will look at a wide range of issues withing the pain therapeutics arena.  It will combine a study of the latest successes in the research and development phase with presentations covering the key themes of biomarkers and the cannabinoid approach.

Questions examined during the conference will include: Do cannabinoid medicines have a place in our pain arsenal?  How do regulatory authorities treat emerging clinical development biomarkers.  What are the latest targets being researched?  How do we treat associated conditions for chronic pain?    How effective is translational research for pain measurement?  Attend this event to discover the latest success stories in researching and marketing pain therapeutics. 

Due to the continuous increase in the number of insoluble developmental drug molecules and growing regulatory scrutiny over pharmaceutical solids, the amorphous pharmaceutical materials have gained importance in the last few years. With the help of interactive discussions, leading presentations, participants will gain a comprehensive outlook of the current market trends, and discover the latest technological developments.

Reasons to register today:
• Understand the use of isothermal calorimetry to characterise stability of amorphous pharmaceuticals
• Implement the latest technological developments
• Discuss the best approaches to control and stabilise amorphous drug forms
• Examine the quantification of amorphous content
• Gain a clearer insight on amorphous food materials
• Seize this opportunity to network with leaders from pharma-biotech, healthcare and regulatory agencies

The global market for ophthalmic pharmaceuticals is a profitable and prestigious segment, set to reach total sales of $32.36bn by 2025 (IMS Health). Glaucoma and retinopathies remain the largest and fastest-growing therapeutic categories, and significant unmet needs. Neuroprotection is now the recognised Holy Grail for glaucoma, along with new technologies to boost patient compliance. For retinopathies, inhibiting geographic atrophy, oedema and neovascularisation remain significant challenges. For both, improved screening methods are driving clinical end-point validation.

Bringing you the latest in basic, pre-clinical, translational and clinical research, we showcase the latest in a field rich in opportunities. Updates from outstanding speakers cover:
• Full market analysis including prospects for pipeline therapies 
• New insights into retinal ganglion cell pathology, degeneration and apoptosis
• Innovative in vivo techniques to increase the spatial resolution of retinal imaging for the optic nerve and retina
• Increasing the effectiveness of neuroprotective agents beyond monotherapy
• Defining and validating clinical measures of neuroprotection
• Sustained release intraocular devices to boost patient compliance
• Gene, encapsulated-cell and cell replacement therapies for retinopathies
• Developments in anti VEGF treatments for wet AMD
• RNAi therapeutics for wet AMD and diabetic macular oedema
• Antibody therapies for age-related macular degeneration and diabetic retinopathy

Protein biotherapeutics have gone from a seldom used subset of treatments to a multi-billion dollar global industry. With the ever-expanding protein therapeutic market, SMi`s 6^th annual Global Protein Summit is well timed to investigate the latest developments in protein therapeutics, cell culture expression and immunogenicity.

The conference will explore the next generation of protein therapeutics, how they are being developed and reassess the technology, discovery and delivery trends. Also covered will be expression optimisation, case studies looking at successful drugs along with immunogenic considerations and safety assessment.

Reassess the latest therapeutics, developments, technologies, and methods that work in an interactive, networking friendly environment with major players from the biotech industry.

This meeting will feature talks from experts who will address:

• Optimisation of pre-formulation approaches, expression and glycosylation
• Next generation nanobodies
• Generating therapeutic antibodies to multi-transmembrane receptors
• Case studies in successful innovative biotherapeutics
• In silico methods to reduce development risks
• Recognising and combating immunogenicity
• Regulatory perspectives

This event will provide you with cutting edge know-how for the successful management of your eCTD lifecycle management. Top industry representatives, regulators and service providers will share with you’re their experience, knowledge and insider insights.

Increasing efforts are being made to protect the national supply chain for medicines distribution. In the US, the pharmaceutical supply chain involves the daily delivery of approximately 13 million prescription products to pharmacies, hospitals, clinics and other healthcare provider locations (Source: Urch Publishing, July 2009). Visiongain`s 5th Annual Pharmaceutical Anti-counterfeiting conference will provide valuable insights, into the latest issues and track and trace packaging technologies shaping the fields of security and supply chain management, with leading experts presenting the best-practices on tackling pharmaceutical counterfeiting and fraud, improving the integrity of distribution channels and relationships between key parties.

By attending this conference you will:
• Measure the impact of counterfeit drugs by using a patient centric approach 
• Understand the development process necessary to ensure an effective security strategy 
• Improve inventory control 
• Hear changes in the US FDA and European policies 
• Develop global standards to increase patient safety and elevate supply chain integrity 
• Learn about leveraging supplier audits throughout a global organization 
• Understand the challenges of the global traceability and serialization regulatory environment 
• Utilize auto-ID advancements in packaging technologies  
• Hear the latest strategies for defending your brand and pursuing offenders 
• Develop working relationships with US law enforcement authorities 
• Balance the need for tamper-proof packaging with streamlining your supply chain 
• Evaluate current methods for the detection of counterfeit medicines 
• Be part of a unique networking opportunity 

This is SMi`s fifth conference on the subject of RNAi, siRNA and miRNA.  It will build on the success of the past four years, and brings together the leading experts in industry and academia to explore the cutting edge of new therapeutics being researched and brought to the marketplace.

Taking place in London, UK, this conference will look at a wide range of issues within the RNAi arena.  It will combine a study of the latest successes in the research and development phase with presentations covering the key themes of delivery, target identification  and IP issues.

Questions examined during the conference will include: What are the best delivery methods for siRNA and RNA-based therapeutics?  How do you carry out gene silencing?  What is the best method to use an siRNA library for target identification?  How is cell stress related to decreased RNAi?  What are the patent issues for oligonucleotides?  How do miRNAs regulate gene expression?

The role of a Key Opinion Leader should extend far beyond product approval. Relationships between KOLs and pharma companies work best when the KOL provides input into all stages of drug development. SMi’s 2nd annual KOL Europe conference will feature presentations from actual KOLs and senior industry professionals with extensive experience of managing scientific relationships. Attend and gain a new perspective on the role of KOLs and explore new ways of using them to achieve successful drug development and marketing strategies. 

The market opportunities for cancer treatments are at an all-time high but the publication rate of clinical trials is low due to factors such as flawed design and failure to meet endpoints. SMi`s Clinical Trials in Cancer conference will feature presentations from industry professionals and academic experts on managing clinical development in this crucial therapeutic area.

Now in its 9th year, Clinical Trials in Cancer has become an essential event for all those working in oncology in the pharamceutical sector. Attend to discover the latest thinking in adaptive trial designs, gain insight into cancer biomarkers, understand the challenges of translational medicine and hear case studies on the logistical and operational issues of conducting clinical trials in Europe.

Absorption, Distribution, Metabolism, Excretion, and Toxicity (ADMET) screening is crucial to the drug development process and assists the elimination rate of weak drug candidates early in the drug-discovery process, and decreases the proportion of compounds failing in clinical trials for ADMET reasons. SMi`s 5^th Annual ADMET Conference will bring you up to date with the latest developments, technologies and techniques that are in use across the industry and look towards the future.

This meeting will feature talks from experts who will address topics including:

• ADMET and PK/PD modelling in drug discovery and development
• Innovative ADME models
• ADME optimisation in early- and late-phase drug discovery
• Drug-drug interaction prediction
• Drug transporter assays
• Predictive toxicology model development
• Emerging in vitro and in vivo toxicity assays
• Metabolism based toxicity

It is our pleasure to present the programme for the 16th World Congress of Basic and Clinical Pharmacology, WorldPharma2010, to be held in Copenhagen 17-23 July 2010.

For this IUPHAR congress, basic and clinical pharmacology, kept separate for too long, have come together again for a remarriage to encompass the whole process of drug development from molecular biology to clinical practice. Here the World’s basic and clinical pharmacologists and all those dealing with the development and use of drugs will meet to discuss how we can work together to meet the need for safe and effective medicines at affordable prices.

As will be seen from the programme, WorldPharma2010 provides in depth treatment of the hottest topics in basic and clinical pharmacology, while at the same time offering the broad perspective of how drugs affect the living organism, which is the foundation of our subject.

The programme is based on 18 two- or three- day focused conferences with a slate of top-level speakers throughout. In addition the programme offers world-class plenary lectures, as well as a range of workshops and sponsored symposia. There is a wide range of possibilities for involvement of young investigators and investigators from developing countries including poster sessions and free communications.

The programme thus provides a unique opportunity for the World`s pharmacologists to meet for what is promised to be a scientifically excellent programme as well as the opportunity to savour the atmosphere of Copenhagen.

• An impressive gathering of Pharmacy Purchasing Professionals from across the country, 272 purchasing professionals, 455 vendor representatives and 86 displaying sponsor companies, were in attendance in Las Vegas at The MGM Grand Hotel and Conference Center for the 13th Annual Pharmacy Purchasing Networking Conference.
  
• As the only national meeting exclusively for Pharmacy Buyers, the Annual Pharmacy Purchasing Networking Conference held in Las Vegas every August offers a unique opportunity for Pharmacy Purchasing Professionals in all disciplines and work settings to come together to learn the latest trends in Pharmacy Purchasing.
  
• On average, an estimated 10 hours of ACPE accredited Pharmacy CE are available each year.

CNS is one of the largest and fastest growing therapeutic areas of the pharmaceutical market. The ageing of the baby-boom generation combined with new and emerging treatments for neurodegenerative disorders, including multiple sclerosis, Alzheimer`s disease and Parkinson`s disease, will lead to further expansion of the neurodegenerative therapies market.

By attending this conference you will:

• Examine novel approaches for assessing cognitive function
• Explore the latest advances in neuroimaging
• Develop effective methods for improved patient recruitment and retention
• Understand statistical thinking for designing adaptive trials
• Review Good Clinical Practice GCP guidelines
• Address the regulatory challenges for CNS drug approval
• Utilise biomarkers for Proof of Concept in CNS clinical trials
• Improve trial outcomes through increased communication, ethical consent and patient care
• Implement translational methods to bridge the gap between pre-clinical and clinical CNS trials
• Be part of a major networking opportunity

After the first "Innovation in Drug Delivery" which took place in Naples (2007) with special emphasis on Biomaterials and Devices, APGI and ADRITELF are pleased to announce the second conference of the series.

This time, we will follow the different steps of the drug delivery system creation: from preformulation to formulation and industrial development, and highlight the role of precise tools for the characterization and evaluation at each level of the process. The programme will include plenary and invited lectures as well as oral contributions. The plenary lectures will also treat topics beyond drug delivery. There will be technical sessions devoted to specific scientific equipment.

SOPs play a crucial role in compliance with regulations. It is therefore essential that they are well written and easy to use by the end-users. If SOPs are not followed correctly, the validity of data generated is compromised, leading to inspection findings and non compliance issues which could lead to delays in bringing a drug/device to market. 

This SOP course has been specifically designed to help you develop the skills to write, produce the content of SOPs, review and implement SOPs and in particular to be able to comply in a regulated environment.  It is essential therefore to have a number of SOPs, and for existing SOPs to be reviewed and updated regularly. Otherwise this is likely to result in major findings by regulatory inspectors.  Participants will come away with the confidence to use a process to write, update and implement SOPs which can easily be used by the end users.

In today’s highly regulated Pharma, Device and Veterinary industries it is essential to use the most efficient processes and ensure compliance with Corrective and Preventative action (CAPA). Regulatory Inspectors are increasing reviewing responses to findings dealt with by the CAPA approach and process improvement.

It is highly likely that the organisations who have already been inspected will be assessed at next inspection in terms of whether the corrective and preventative actions have been implemented – has the organisation done what they said they would? If previous major findings have not been addressed then a critical finding may be given. This course will be ideal for you to learn how to improve industry procedures and processes and how to implement and document an effective CAPA quality system.

Key topics to be addressed at this conference:

• Principles of Pharmacovigilance and Data Resources
• Risk Management
• Causality Assessment: Clinical Diagnosis of Adverse Events
• Pharmacoepidemiological Studies
• Practical Aspects of compiling PSURs
• Pro-active Pharmacovigilance Pre- and Post Marketing
• Monitoring and Reporting Adverse Reactions in Europe: Regulatory Framework, Clinical Trials, Post-Marketing
• Risk/Benefit Analysis
• Drug Surveillance in the USA & Japan
• Prescription Event Monitoring and its Practical Use in England
• Practical Pharmacovigilance Workshop
• Approaches to organisation of safety surveillance in major pharmaceutical companies

This seminar will focus on changes to GMP stimulated by the introduction of ICH Q10 on Pharmaceutical Quality Systems (PQS) with main focus on changes to Chapter 4 on Documentation of EU GMP.

• What is the impact of ICH Q10 and proposed Changes to EU GMP Chapter 4 on Documentation for the GMP Environment?
• The framework for a Pharmaceutical Quality System
• Understanding the Difference between Instructions and Records propsed by these Changes to EU GMP
• How good are your SOPs (Instructions) and the Evidence of Actions (Records)?

1. The most senior speaker line-up in Europe. Where else could you hear from (and meet with) the most senior speakers from top 10 pharma? Sign up now to make sure you`re at this top-level gathering
2. Even more effective informal networking. BioBusiness attendees come back year after year because they know they`ll have more opportunities to meet with their senior-level partners than anywhere else. Catch up with colleagues over coffee and make new contacts over dinner
3. The BioBusiness Agenda. We control the content of the BioBusiness agenda to ensure it adds maximum value to your time at the conference. With high-level panel discussions, case studies and insights, you`ll have to plan your networking carefully to take it all in!
4. We cap the number of attendees at BioBusiness to ensure the event remains intimate and effective for networking. No one wants to spend their days fighting through crowds of irrelevant people and BioBusiness cuts them out to help you ensure all your conversations have a business goal in mind.
5. We`ve reviewed our 1-2-1 technology to make it even more effective this year. Make sure you book up your meetings before the conference so you can arrive with your most critical meetings already lined up.

Pharma IQ is delighted to announce the dates for the 7th Annual PAT and Quality by Design forum taking place in London on the 19th-20th January 2010. PAT and Quality by Design is one area within the pharmaceutical industry that constantly sees exciting developments and with the occurrence of the FDA pilot and other regulatory bodies also increasing their activity within the field, this year is no exception which really does bode well for some exciting new stories and discussions this year.

This 7th Annual event has seen over 400 attendees travelling from approximately 20 countries in its years since conception and consistently provides a forum for both PAT and Quality by Design professionals to discuss pressing topics and new initiatives taking hold within the area, as well as network with new people and increase their contact base.

This seminar will focus on R&D based pharmaceutical products in Asia and will provide you with:

Active comparator trials can fulfil a number of needs from pivotal marketing approval studies, through label enhancements of an already marketed drug to post-marketing market support. The designs of such studies have their own special issues: superiority vs non-inferiority designs, choice of comparator, two arm or three arm placebo designs amongst many others.

This course aims to discuss the theoretical, operational, regulatory and statistical issues involved, using practical examples to encourage interactive discussion to share possible approaches to the design and implementation of active comparator trials.

Topics to be covered at this meeting:

• Purposes of active comparator trials
• Design for studies
• Statistical considerations
• Regulatory documentation & safety monitoring
• Safety data collection & reporting
• Post-marketing comparator observational studies

Allosteric modulators are an emerging class of orally available small molecule therapeutic agents that may be able to offer patients better outcomes than with traditional small molecule therapies. This potential stems from their ability to offer greater selectivity and better modulatory control at disease mediating receptors. Modulators bind to regulatory sites distinct from the active site on the protein, resulting in conformational changes that may profoundly influence protein function. The advent of functional assays as the screening method of choice is leading to an increase in the number of allosteric modulators identified.

At Arrowhead’s 2010 Allosteric & Orthosteric Modulator Congress, presentations will highlight key developments in the field of allosteric and orthosteric modulator drug discovery and clinical development.

A Two-day Comprehensive and Interactive Course with Workshop on:

• Critical Elements of Stability Program and Stability Testing
• FDA, Health Canada, WHO and ICH Guidelines; Q1A, Q1C, Q1D, Q1E, Q1F, Q2A, Q2B, Q3A and Q3B
• ICH Climate Zones
• Types of Stability Studies - Stability Study Designs
• Developmental Stability Studies (i.e., Phase 1 to 3)
• Consistency Studies for drug submission
• Validation Studies
• Routine Stability Studies (Marketed products)
• Setting-up Stability Program Policies, Procedures, SOPs and Study Protocols
• Preparation of Stability Reports
• Consideration in Developing Stability Indicating Methods
• Designing Reduced Testing Program: Bracketing & Matrixing
• Rational for Study Duration and Shelf-life Determination
• Testing Intervals; Long Term and accelerated
• Study Stability Batch Selection, Sample Size, and Sample Management
• Stability Chambers: Mapping, Qualification and Monitoring
• Study Tracking
• Stability Testing and Evaluation
• Stability Trending, Failure Investigation; OOS, and OOT
• Review of Recent Stability Related 483s

The 2010 Biomanufacturing Summit brings together world class leaders within biopharmaceuticals to explore the dynamic strategies, benchmark the latest technologies and analyze the most cutting edge science sustaining the growth of the biopharmaceutical industry.

With the inevitability of biogenerics in the US and the increasingly tighter federal regulations it is apparent that companies have to streamline processes, maximize capacity and reduce costs to successfully navigate the complex landscape of biological production. Join us at this premier conference and networking event designed specifically for senior executives in manufacturing, process development and product operations. The 2010 Biomanufacturing Summit features in depth case studies and interactive sessions from world class biopharmaceutical manufacturers helping you drive forward innovation and increase process efficiency.

With increasing generic competition, challenging molecules coming through discovery and continual pressure to produce cost-effective drugs, companies are increasingly turning to formulation and delivery to secure the success of current and new drug products.

World Drug Delivery and Formulation 2010 is the event this year for both scientific and business leaders working in formulation and delivery to debate the challenges affecting them.

This multi stream delivery and formulation event will focus on both scientific and business issues. This will give everyone the perfect opportunity to attend sessions dedicated to their main area of interest, whilst networking with scientific and business peers from across the entire formulation and delivery spectrum.

9th Annual Cool Chain Europe is shaping up to be better than ever...

Cool Chain professionals have come to rely on the annual Cool Chain Europe conference and networking forum for the latest information, best practices and solutions for monitoring and controlling temperatures of biopharma products and clinical supplies.

• New Regulatory and Industry Standard Insights on CRT, stability data and GDP best practices from Austrian Ministry of Health, EMEA, Dutch Health Inspectorate, MHRA, WHO and PCCIG
• Cost-effective transportation and cool logistics presentations by UCB Pharma, Bayer Healthcare, Pfizer and Novo Nordisk who are conducting pilots and actual cold chain shipments by Ocean, Air and Road – balancing quality and cost, while increasing control and transport reliability
• Bio Logistics and Packaging sessions, by GlaxoSmithKline, Omrix Biopharmaceuticals and Talecris Biotherapeutics will show how companies are ensuring their biopharma drugs are carefully handled according to GDP and GMP standards
• International Distribution and New Markets presentations by Abbott Labs, Sensitech and Abbott Logistics B.V. on import/export compliance for international trade and challenges shipping to Brazil, Mexico and Venezuela
• QA & Quality Distribution viewpoints from Merck Sharp & Dohme, TopoTarget and Sanofi-Aventis on risk management for temperature sensitive pharmaceuticals and getting more out of your stability data

This interactive course will provide you with the skills and knowledge to be a successful and effective CRA or member of Clinical Trial Support staff. It covers all the key aspects which CRAs and support staff are likely to be involved in as well as the most important interpersonal skills necessary to be an effective CRA. This will include: 

• Planning and preparation for setting up clinical trials
• Understanding the responsibilities at both the study site and the sponsor site
• How to carry out the crucial study site visits including
• How to prepare for an audit and/or regulatory inspection
• Technological advances on collecting data - EDC

• What’s New in Publication Planning – Trial Registration, FDAAA, CME
• Understand the imp
• Understand GPP2
• Clarify issues regarding Authorship and Ghostwriting
• Understanding Copyright
• How can you Work with Press
• How do you Measure Quality – Metrics and Benchmarking

The quoted fee is a residential rate, and includes four nights’ accommodation and all meals. The non-residential fee is available on request.

The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians.

WHAT YOU WILL LEARN FROM THIS COURSE

• The multiple and complex stages and procedures involved in the development of a new drug
• How many different skills are used in drug development
• How to relate your own responsibilities to the professional knowledge and needs of others in the chain
• The pitfalls that can prevent a new drug coming to the market 
• Why drug development is so expensive, and where the money goes
• Current trends and future prospects for global drug development

"The dizzing pace of innovation promises to redefine healthcare. The combination of biotechnology with nanotechnology, medtechnology and information technology will transform the way doctors monitor, diagnose and treat disease.

BioSquare is totally part of this deep and global transformation of the sector: the conference is a two-day event which aims at bringing together stakeholders from across the value chain of these innovative technologies convergence. BioSquare 2010 will concentrate time and expertise for theses companies looking for partnerships in one of the world’s key financial place.”

1. Anti-infectives
2. Biologics
3. Cardiovascular
4. Central Nervous System
5. Diabetes & Obesity
6. Developments in other Therapeutic Areas
7. Drug Delivery
8. Drug Discovery & Therapy in the Middle East: Challenges and Opportunities

Drug development is a complex process which needs effective project management. With ever increasing pressures to complete the development of drugs as quickly as possible, the effective use of project management can provide essential tools and techniques to achieve this. Indeed effective project management can be a key factor to successful completion of bringing a drug to market.

• An understanding of the key areas of regulatory affairs
• A focus on the Middle East including Israel
• A focus on the practical aspects to assist with regulatory activities in the region
• The opportunity for you to participate in interactive discussions
• Break-out sessions
• The opportunity to exchange experiences with other delegates

The development of a veterinary medicine is complex, time consuming and expensive. It requires teamwork from individuals with different scientific training and a wide range of skills. Everyone involved must be aware of the main stages in the development programme and be able to relate their responsibilities to the expertise and needs of the scientists and commercial members of the team.

This course has been designed to demonstrate how pharmaceutical, pharmacological, toxicological and clinical investigations and regulatory management are brought together in the development programme. It will take the participants through all of the stages in the development of a veterinary medicinal product for companion animals, for which a marketing authorisation is sought in the European Union.  Presentations will cover pharmaceutical and process development, toxicological, pharmacological, safety risk assessments, clinical development and regulatory submissions. An important part of the course will be devoted to working on case studies in the workshop sessions.

Topics covered at this two day meeting:

Structure and functions of the FDA

• Historical background
• General regulatory requirement
• Regulation of preclinical and clinical research
• New drug application process
• Biologics
• Special issues
• Recent legislation, including Food and Drug Administration Amendments Act of 2007 and proposed legislation to govern follow-on biologics

Assessing innovations in drug delivery technologies and evaluating business models

Drug delivery continues to be increasingly important sector in the pharmaceutical industry and has undergone rapid growth in the last few years.

Drug delivery technologies are driving growth of pharmaceutical companies and boosting their revenue by extending the product profitable lifecycle through new formulations, combinations and repositioning.

The predominant focus of this conference will be in advancements being made in the drug delivery technologies and understanding the regulatory and legal issues faced by the them.

By attending this conference, you will hear from leaders with expertise in this area their experience and new concepts. It is not to be missed!

There is no comparable Congress in the region where all the requirements of the pharmaceutical sector can be found in one place. marcusevans congresses applies this approach to all of its events ensuring that all participants derive the maximum value from their time out of the office.

The quality and diversity of this year’s event is mainly due to coalition of senior technical and compliance experts from pharmaceutical, and life sciences sectors addressing several hot topics that are particularly important to your day-to-day professional function including:

• Quality Control for biologics
• Planning and conducting Viral Clearance studies
• Regulatory aspects in biotechnological manufacturing
• Development and manufacturing of biopharmaceuticals
• Filtration and Separation technologies
• Computer & Software Validation
• Design and Management of  Environmental Monitoring Program Design

Consequences of EU pharma package for the packaging - GMP Compliance - Process and Efficiency

Ensure quality and to ensure tamper-proof;

These are the Top challenges for Pharmaceutical Packaging 2010. Finally, the EU pharma package plans far-reaching measures in the field of anti-counterfeiting measures. Not only the introduction of a single pan-European identification system represents the pharmaceutical industry faces enormous problems. The Integration into existing packaging processes and increasing demands on the Flexibility of packaging represent mission-critical tasks for 2010!

• Learn more about current regulatory requirements such as the EU pharma package, Braille policy and Readability Guideline
• Learn Track & Trace Solutions to integrate into your packaging processes
• Optimize your GMP ComplianceIn order to be fully prepared for inspections
• Customize your packaging processes for Individual Combination Products in to the market needs to be flexible
• Find out what the results EFPIA pilot project in Sweden with the introduction of standardized 2D Data Matrix codes has made

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Maximising the ability to identify a potential blockbuster drug has never been so important in the Pharmaceutical industry.  With many of the hugely successful drugs from the 90`s coming to the end of their patents, the pressure is on to develop the next big hit.  This has meant the design of strong lead compounds is a must, and new strategies are being developed for this wherever possible.

SMi`s 9th Annual Advances and Progress in Drug Design conference aims to address the latest developments in drug design and offer tangible examples of these processes in practise.  Attended by senior representatives from all the leading pharmaceutical companies this conference allows you to stay ahead of the game in drug design.

A two-day comprehensive and interactive course, workshops, and case studies on:

• Guidance Documents for Drug Master Files (DMFs) US, Canadian and European Regulatory Requirements
• Role of DMFs in the regulatory approval process for drugs and biologics
• Comparing the Types of Drug Master Files
• Preparation of United States Drug Master File (US-DMF)
• Preparation of European Drug Master File
• Compiling necessary document for DMF Submission
• Regulatory reviews of DMFs
• Strategies for Communications with FDA and other regulatory agencies
• EU and US efforts to harmonize DMF systems
• Steps of DMF preparation
• Essential Information for a Drug Master File
• Key Documents associated with DMF
• Customizing DMFs for particular products and businesses
• Binder Specifications and Cover Samples
• Annual Updates and Amendments
• Techniques for tailoring DMFs to CTD format 
• Assessing supplier Type III DMF’s

Interactive Discussion Sessions

• Current Issues with APIs and Type II DMFs
• Successful Preparation of Type III DMFs

Strengthening End-to-End Cold Chain Practices in Distribution, Packaging and Compliance of Temperature Sensitive Pharmaceuticals

With the overwhelming complexity of assuring product integrity throughout the entire distribution chain, the stability of the product is of paramount concern as it moves through the chain of custody.

Pharma IQ’s 8th Cold Chain Management & Temperature Control Summit provides the largest and most comprehensive forum for Canadian pharmaceutical, biotech and medical device professionals involved in the temperature-controlled supply chain. Attendees are able to network with and learn from other organizations who face similar challenges in monitoring, controlling, and maintaining temperatures of products throughout the supply chain – from manufacturing, warehousing, wholesalers, pharmacies, hospitals, and ultimately to the end user.

• Rational approaches to pre-formulation and formulation process
• Designing product-specific freezing and sublimation and desorption protocols
• Improving analytical methodology to characterize frozen systems and freeze-dried solids
• Characterizing the final dried formulation
• Accurately predicting product stability at the intended storage temperature
• Ensuring cGMP, QbD, QC and QA
• Consistently achieving the desired product quality
• Improving process engineering dynamics and scale up
• Troubleshooting manufacturing problems
• PAT in manufacturing and the lab

An Interactive and Comprehensive One & Half-Day Course On:

• Formulation and Production cGMPs
• Pharmaceutical Mixing
• Materials for Direct Compression
• Formulation with Binders, Fillers, Glidants, Lubricants, and Disintegrants
• Screening and Sieving - Particle size reduction
• Dry Granulation and Wet Granulation
• Fluid bed Technology
• Tabletting Principles and Equipment
• The Seven Stages of Compression
• Maximum allowable Punch Tip Loading Overload systems.
• Tablet Tooling –Elegant products are dependant on tooling design.
• Challenges with concavity and engraving
• Coating Principles and Equipment
• Sugar Coating, Film Coating, Modified release Coating
• Understanding colours, polymers and spray application
• Encapsulation Principles and Equipment
• Scale-Up and Technology Transfer Considerations
• Problem solving and Troubleshooting
• Future Trends and New Technology

The world’s first and only antibody event designed by you…

The Biorbis Antibody Engineering and Design conference is a new breed of antibody meeting, different to any other you`ve experienced.

Because it`s been designed by you.

It`s been designed by people from companies like Genentech, MedImmune, Roche, Abbott, Johnson & Johnson, Biogen Idec, Merck, UCB Celltech, Pfizer and many other big pharmaceutical companies and innovative biotechs.

Here are just some of topics covered on the agenda:

• Engineering antibodies with enhanced characteristics. Isotype choice, half life, stability, efficacy, immunogenicity, using structural insights and more…
• Utilizing structural-based drug design. How to enhance structural understanding, epitope mapping and using crystallization studies to improve subsequent development
• Reduction of manufacturing risk and improving expression early in the development process
• How to ensure appropriate species cross-reactivity
• How to improve anti-tumour activity through better antibody design. The thoughts of several of the world`s leading oncology experts and case studies
• Generation of multivalent antibodies and use combinatorial strategies to combat cancer
• Discovery of suitable antibody candidates and identification new targets via novel strategies

A one and a half day course covering GMP essentials including:

• History of US GMPs
• International Regulatory Authorities and Regulations
• Regulations and Guidelines
• Personnel and Organization
• Buildings, Facilities, and Utilities
• Equipment
• Materials Management and Supplier Controls
• Manufacturing and Packaging
• Labels and Labeling
• Laboratories and Testing
• Storage and Distribution
• Records and Documentation
• Risk Management
• Validation
• Quality Management Systems
• Change Management
• US FDA Inspectional Process

5th ANNUAL BIOMARKERS CONGRESS: the leading event for biomarkers practitioners

The pharmaceutical industry is facing high clinical development costs and declining drug discovery success rates. To stay competitive companies are re-evaluating their drug development process to reduce attrition rates. Biomarkers promises to transform drug discovery, clinical development and molecular diagnostics in the R&D process as effective use of biomarkers at each stage of R&D can improve decision-making, increase clinical trial success rates and productivity.

The 5^th Annual Biomarkers Congress 2010 presented by Oxford Global Conferences provides a first class educational and networking opportunity for over 175 attendees to gain knowledge and insights into the Biomarkers marketplace.

The event explores core topics such as the ROI of Biomarkers, the key role of personalised medicine and diagnostics, safety biomarkers and biomarkers within clinical development, biomarker discovery & validation in different therapeutic areas as well as the integration of applications and enabling technologies such as imaging, metabolomics and microRNA to maximise biomarker identification. 

Do not miss out on the opportunity to learn how you can streamline your R&D process and identify potential cost savings through successful biomarker discovery, validation and clinical development. Focus on the integration of technologies & applications to bridge the gap between Discovery, Validation and Development.

Review of the New Variations Regulations

An introduction to the EC system for Variations with practical advice on the preparation and submission of Variation applications using the various European procedures

• The New Variations Regulations of the European Commission and procedures in practice
• Review of latest requirements
• Renewals
• Pharmaceutical Variations
• Clinical Variations
• The New Variations Regulations: how have they changed processing of variations

The Pharma and biotech sectors are at a pivotal point in their evolution. The companies are facing significant pressure to change with thinning pipelines, skyrocketing R&D costs, calls for lower prices and a greater regulatory burden, these conditions together with the financial crisis have made the work of creating new drugs harder than ever. Big pharmaceutical companies are being forced to globalize their R&D operations, especially to emerging markets.

Led by China and India, Asia is growing into a drug manufacturing powerhouse and a leading source of drug discovery and high-end innovation during the recent years. Big Pharma companies now rank China as the best location for conducting R&D in Asia, followed by India, Korea and Taiwan, respectively.

• Attend presentations by more than 350 speakers
• Hear representatives from the EMEA, FDA and regulatory agencies throughout Europe
• Attend preconference tutorials
• Network with professional colleagues from around the world
• Visit more than 200 exhibitors in Europe’s largest interactive exhibit hall

WHY SHOULD YOU ATTEND?

• Gain a refresher/update on the technical aspects specific to the regulation of rDNA derived medicinal products
• Improve your knowledge of the differences between the regulation of rDNA products and conventional small molecule drugs
• Compare experiences with delegates from across Europe

* Please note – the seminar assumes a scientific background and a basic knowledge of drug regulatory affairs

WHO SHOULD ATTEND?

• Life scientists moving into biotech regulatory affairs
• Technical and scientific decision makers in biotech start up operations
• Those with a life science background in the financial sector involved in due diligence or regulatory portfolio
• Those from small molecule backgrounds transferring to biotech product regulatory affairs