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
