Title: Unlocking BLA, NDA, IND Submissions
Date: January 26, 2021
Time: 5PM CET
Duration: 1 hour
Key Learnings:
- eCTD submission for BLA
- Compilation and submission lifecycle of a BLA
- Main differences to other application types such as IND and NDA
Speakers:
Adair Turner
Principle, Consultant, Director RegOps, PharmaLex
Karl-Heinz Loebel
Director, Principal Consultant RegOps Industry/Agency Liaisons, PharmaLex
Melissa Rapp
Manager, RegOps, PharmaLex
Parul Patel
Senior Product Consultant, LORENZ Life Sciences Group
Akira Yamaguchi
CTO, LORENZ Life Sciences Group
Jan Wermusch
Product Manager, LORENZ Life Sciences Group