The 2nd Biosimilars Summit: Analytical Similarity, Clinical Studies and Market Entry 2017 is a conference dedicated to the analytical and clinical phases of biosimilar drug development, current regulation, the quality attributes needed to prove interchangeability, and the market.
Topics
- Best practices for navigating the abbreviated licensure pathway for interchangeability
- Managing the functional assay testing for quality attributes that regulators value
- Developing effective Three-Way PK-Bridging Studies for Global IND Strategy
- Leveraging the FDA’s "Totality of Evidence" Methodology for Using Reference Products
- Streamlining the Process for First-in-Human Clinical Trials of Biosimilar Products
- Effective Clinical Trial Monitoring to Prepare for Post-Marketing Pharmacoviligance
