Well Characterized Biologics & Biological Assays

MEET DIRECTLY WITH THE FDA AND REGULATORY SPEAKERS

Each year, this meeting brings in 5+ FDA speaker's from CBER/CDER that are onsite with a big presence. They’ll be able to answer all of your regulatory questions and present on some key topic areas of interest. We’re finalizing the representatives that are coming. In the meantime, here are some potential topic areas that will be addressed:

Most Problematic Areas of Submissions for Analytical Characterization and Bioassay Development

Regulatory Updates and Insights on Emerging Technologies for Analytical and Bioassay Development

Regulatory Guidelines on Analytical Procedure Validation vs. Qualification

FDA Town Hall - Open Forum Q&A with Multiple FDA Reviewers