Improve predictive modelling success and explore alternatives to testing in
accordance with regulatory guidelines
Predictive
toxicology is the first step in developing any
viable drug on the market. Toxicology testing has evolved greatly to
incorporate the possibility of using alternatives to animal models and
the
application of biomarkers to evaluate adverse effects. There is also
cutting-edge research into areas such as CNS and cardiovascular disease.
By
understanding technological advances in how to best use in vitro and in silico methods to better predict in vivo results,
a company
can cost effectively develop drugs that will ensure market survival.
This
2nd annual marcus evans
conference will provide valuable knowledge to enhance drug development
strategies
by profiling novel solutions for toxicology screening with the latest
predictive tools. Attendees will receive key industry and regulatory
insights
on overcoming regulatory pressures in achieving approval on biomarker
use for
models and qualification of data on products. The use of outsourced
contract
research organisations (CROs)
will be evaluated which in turn will provide analysis on minimising
costs and improving data quality to ensure business success.
Whether you work in production or in a laboratory or if you conduct
investigations or finalize product release, sound data and information
is essential to success and compliance. To ensure success and avoid
those frustrating, embarrassing discussions of missing or doubtful
data, laboratory employees must follow good documentation practices.
According to the FDA, if it isn`t written down, it didn`t happen. As
well, if it isn’t written down clearly, it didn’t happen either. GMP
compliance (21CFR, Part 211) requires the use of good documentation
practices. These practices apply to all pharmaceutical manufacturing
and support areas. Good Documentation Practices describe the required
activities and steps to use when recording data and other handwritten
entries. Personnel who work with documentation must be informed of
these requirements, recognize their significance to their job and be
aware of the consequences of non-compliance. During this 1-hour
webinar, we will review the Good Documentation Practices plus
demonstrate examples of these practices (both good and bad!) as they
apply to the pharmaceutical arena.
A robust Corrective and Preventive Action (CAPA) program is of the
utmost importance to a medical device manufacturer. A system that
identifies and eliminates nonconformances and potential nonconformances
enables both regulatory compliance and cost savings. This session will
discuss the importance, requirements, and elements of a CAPA program,
as well as describing the uses of CAPA data. Additionally, the
application of risk management to a CAPA program will be reviewed, and
a specific risk management system explained.
Areas Covered in the Session:
QSR and ISO 13485 requirements for CAPA
Elements of a cross-procedural CAPA program
Applications of CAPA
CAPA data and its uses
Application of risk management to CAPA program
Who Will Benefit: This webinar will provide
valuable assistance to all regulated companies, a CAPA program is a
requirement across the Medical Device, Diagnostic, Pharmaceutical, and
Biologics fields. The employees who will benefit include:
The Meeting aims to bring together many internationally renowned scientists and young scientists from academia and industry, working on drug/xenobiotic research in diverse fields including basic and clinical pharmacology and therapeutics, toxicology, oncology, endocrinology, physiology, biochemistry, medicinal chemistry, drug discovery and development, molecular and structural biology and genetics, and other related areas.
The scientific program will include recent advances on the structure, function and regulation of drug metabolizing enzymes and transporters; omics based technologies for drug discovery and for drug/xenobiotic toxicity assessment; physiologic and/or toxicological roles of novel extrahepatic drug metabolizing enzymes; prediction and mechanisms of adverse drug reactions; environmental toxicology and health, and chemical carcinogenesis. Exciting sessions will be devoted to pharmacoepigenetic and microRNA dependent drug metabolism and action; toxicogenomics, a predictive tool in toxicology and drug development; epigenomics – impact for drug safety sciences; nutrition and cancer prevention; pharmacogenomics and cancer treatment; oxidative stress, DNA damage and repair and biological considerations. Contemporary issues in drug/xenobiotic research including bioengineering of new enzymes, nanotechnology and stem cell research will also be in the scientific program.
Space for special High-quality and original promotional products find their place here. We provide manufacturers, importers and distributors of innovative, design-oriented products, the possibility of their products to a new visitor audience present.
The actors (exhibitor target groups)
On Promotional specialized companies that offer high-quality items
Company with its own line of advertising / B2B Area
Advertising and promotion agencies with full-service
The audience (visitor target groups) Specifically, we invite buyers to the forum promotional, marketing managers and decision makers received from:
Logipharma China is the leading Pharmaceutical supply chain and logistics conference addressing your key supply chain challenges across two value driven days.
Attracting over 100 senior supply chain and logistics professionals from pharmaceutical wholesalers and manufacturers, the conference addresses your top supply chain challenges including: temperature controlled distribution, distribution trends, government regulation, cost management, warehousing, demand planning and security.
Logipharma China is the only event that brings together all the key suppliers and logistics practioners in China, no other event goes into as much depth on the issues unique to China.
XVI International
Specialized Exhibition of medical technique and diagnosis devices,
pharmaceuticals, stomatology equipment, instruments and consumables
As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not Followed" (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported immediately. Principal investigators in clinical trials are expected to adhere to the study protocol. Instances of “Protocol Not Followed” (PNF) are not addressed in the CFR or other regulatory rules. The various terms used to describe PNF (violation, deviation, and exception) are open to different interpretations by the parties involved. Attend this Webinar to understand the proactive approach to define and manage Protocol Deviation/Violation/Exception. What is the approach to predict and prevent it.
Proper documentation and reporting of PNF as they occur is helpful for investigators and study sponsors, as these data can be used to determine the need for amendments to the protocol and/or the related documents. The monitoring of the frequency and nature of PNF can also be used as a quality assurance measure for the site. A noncompliance with the study protocol should be reported as soon as it is identified. This is consistent with Good Clinical Practices (GCPs).
This Webinar will also discuss the guidelines for implementation of PNF to include capturing, reporting and documentation.
Areas Covered in the Session:
How to define and manage Protocol Deviation/Violation/Exception
Proactive approaches to predict and prevent clinical trial protocol violations
Industry and FDA perspectives on Protocol Deviation/Violation/Exception
Discuss the current lack of unified definition for protocol deviation/violation/ exception
Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including:
AstanaZdorovie provides an opportunity to meet thousands of
potential clients face to face, learn about new developments in
medicine, discuss pressing issues of the sector, build new business
contacts, present your products and services, increase your sales and
study the market, add to your company’s image and position yourself in
the market of Kazakhstan.
Main
Sections of the Exhibition
Medical Equipment and Machinery
Laboratory Equipment / Technologies
Diagnostic Equipment
Medications
Surgical Instruments
Orthopaedics and Rehabilitation
Dental Materials and Services
Optics and Ophthalmology
Biotechnologies
Medical Services
Hospital
Motherhood and Childhood Health Care, Children’s Nutrition
Homeopathy, Food Supplements
Raw Materials and Ingredients for Pharmaceutical
Production
Important
Due to possible changes in conference details, we recommend that you check with the conference
website, before making any traveling arrangements.
* Prices are for evaluation only. For accurate prices, please check with conference website.
