Biosimilars 2013

Key Topics

• Financial viability of manufacturing biosimilars and alternative pathways for approval
• Regulatory guidelines
• Strategies to overcome legal issues to gain marketing approval
• How to incorporate a patent portfolio strategy to prepare for the changing landscape
• The role of the US and European market in developing biosimilars
• Pre-clinical and clinical challenges in proving interchangeability and patient safety
• Pharmacovigilance framework to monitor patient safety
• Pricing and reimbursement plans especially for meeting government healthcare demands

Who should Attend

VPs, Directors, Heads, Managers of:

• Biologics/Biotechnology/ Biogenerics
• Follow on Biologics/Follow on Proteins/Biosimilars
• Intellectual Property
• Legal Affairs
• Pricing and Reimbursement
• Health Economics
• Clinical Immunology
• Biopharmaceuticals/ Biotherapeutics
• Chief Scientific Officer
• Principal Scientist
• Analytical Characterisation
• Process Control and Analytical Technologies
• Pharmacovigilance
• Regulatory Compliance
• Quality Affairs/ Quality Control
• Drug Safety & Risk Management
• Process Science
• New Product Development
• Research & Development
• Portfolio Management
• Business Operations
• Business Development
• Commercial Affairs
• Scientific Affairs
• Marketing