Biosimilars

Biosimilars is a course dedicated to biosmilars and how they differ from the original biological product.

Topics

• The regulatory pathways for biosimilars in the EU and US
• Global considerations and definitions of biotech/biosimilar products
• How to develop effective strategies for development of biosimilar products
• Key Module 3 dossier requirements for biotech products versus pharmaceutical products

Who should Attend

Attendees from:

• Quality assurance
• Regulatory
• R&D
• Pharmaceutical development