Ben Clarke
Senior Scientist, Global Biologics U.S. Pharmacopeia
Seminars
Wednesday 28th October 2026
Interactive Discussion: Ask the USP
10:00 am
- Opening up discussion on proposed revisions to USP Chapter 1043, with a focus on the 4-tier risk assessment system
- Bringing together differing views on the tiered approach, encouraging participants to share perspectives and challenge assumptions
- Exploring what these potential changes mean in practice for raw material risk assessment and decision-making
Wednesday 28th October 2026
Creating Confidence Through Raw Materials Quality Standards for Cell & Gene Therapies
9:30 am
- Discussing USP Chapter <1043> on ancillary material quality, risk assessment and material qualification
- Noting recent developments in compendial methods for raw materials
