Topics
- EMA guidance on immunogenicity assessment of biotechnology derived therapeutic proteins
- Regulatory requirements for the registration of Biosimilars
- Risk benefit conclusions and relevancy to clinical practice
- How to Prepare Module 3 of the Common Technical Document: Special issues for Biosimilars
Who should Attend
Attendees working in departments such as:
- Portfolio and Project Management
- Biogenerics/Biosimilars/ follow on Biologics/Biotechnology
- R&D
- Clinical Development
- Process Development
- Product safety and Quality Management
- Regulatory Affairs and compliance
- Corporate Strategy
- Legal Affairs
From Pharmaceutical, Biotechnology, CRO and Generic companies.
