3rd Annual Clinical Trials Asia Summit 2013

The Annual Clinical Trials Asia Summit is a conference dedicated to the Indian pharmaceutical industry and cover topics such as:

• New trends in global clinical trials and their role in India
• Indian healthcare and clinical trial system towards 2013
• Regulatory authorities and structure in India
• Strategies to conduct successful interventional oncology trials in India
• Drugs Controller General of India (DCGI) and Central Drugs Standard Control Organization (CDSCO)
• Regulatory approval processes and achieving drug/ clinical supplies import and export licenses in Asia
• Open and effective outsourcing partnerships
• Incorporating GCP & GCPs
• Decision criteria for partnering with the right vendors in Asia
• Smart packaging solutions to balance quality and costs
• Risks in clinical trials and incorporating risk sharing models in clinical trials
• Secure and increase global drug supply in the public sector
• The right clinical trial supply chain model to optimize the costs
• Accelerating patient recruitment & retention in clinical trials
• New e-clinical technologies to improve data quality and optimize clinical outcomes
• Avoiding mistakes in data collection and ensuring profitability
• Next generation of clinical trials

The Annual Clinical Trials Asia Summit brings together managers from the following sectors:

• Generic pharmaceutical companies
• Pharmaceutical Organisations
• Patient Recruitment Companies
• Contract Research Organisations
• Non-profit organisations/ Association
• Government- Department of Health
• Consultants
• Academics

y development

• Biosimiliars and clinical trials solutions
• Pricing and reimbursement challenges to maximise the ROI
• Clinical challenges with biosimilar drug development
• Commercial challenges and opportunities
• Investments & potential returns from Biosimilars
• Recent successful strategies and business models
• Biosimilars Vs Bio-betters
• Regulatory framework in advanced and developing markets
• FDA`s current view of biosimilars
• Critical issues in demonstrating biosimilarity and maintaining diligent quality control
• EMA Regulatory Opinions on Treatment of mAbs

The BIOSIMILARS CONGREGATION brings together CMOs, CSOs, Presidents, Vice Presidents, Directors, Heads, Senior Scientists and Team Leaders from the following roles:

• Business Development
• Analytics
• Corporate Development Strategy
• Business Strategy
• Intellectual Property
• Commercial Affairs
• Medical Affairs
• Marketing & Sales
• Legal Affairs
• NewProduct Development
• Preclinical and Clinical Development
• CMC
• Regulatory Affairs
• Product Development
• Research and Development
• Pricing and Reimbursement
• Quality Assurance
• Biologic Production
• Strategic Planning
• Scientific Affairs
• Strategic Sourcing