Biosimilars and Follow-On Biologics 2019 Americas

Topics

• Clinical and preclinical challenges in the development of biosimilars
• Global regulations and guidelines for Biosimilars including variations and new developments
• Conducting trials, assessing immunogenicity and pharmacovigilance
• Challenges encountered with specific product manufacturing
• Issues in developing biosimilars mAbs
• CMC requirements in order to produce high quality similar biologic product
• How the BRIC market is dealing with Biosimilars

Who should Attend

Directors, VPs, Managers and Heads from:

• Follow on Biologics/Follow on Proteins/Biosimilars
• Biologics/Biotechnology/ Biogenerics
• Biopharmaceuticals/ Biotherapeutics
• Legal Affairs
• Intellectual property
• Pricing and Reimbursement
• Clinical Immunology
• Regulatory Compliance
• R & D
• Preclinical and Clinical Development
• New Product Development
• Quality Affairs/ Quality Control
• Principal Scientist
• Pharmacovigilance
• Chief Scientific Officer
• Drug Safety & Risk Management
• Health Economics
• Process Control and Analytical Technologies
• Business Development
• Commercial Affairs
• Marketing & sales
• Intellectual Property
• Legislation and Policy Advice
• Business Development
• Licensing
• Manufacturing
• APIs
• Bioequivalence
• Drug and Safety Assessment
• Market Strategy
• Regulatory Affairs