Vandana Sharma

Company: Astellas Gene Therapies

Job title: Associate Director

Seminars:

Considerations for Raw Material Selection and Testing to Support a Commercial Product 3:15 pm

Understanding the nuances of defining raw materials as ancillary or excipient Clarifying USP, EP, BP and JP raw material grade requirements: what grade of material should I be selecting? Ensuring security of supply and quality of materials for CGTsRead more

day: Conference Day Two

Panel Discussion: Highlighting Key Differences in Global Supply Chain Regulations Between Different Bodies 3:45 pm

What are some key US vs EU regional differences that impact critical and/or raw material sourcing, and supply chain continuity for drug sponsors? How do expectations and benchmarks differ between the FDA and EMA? Practical advice for CGT developers working in both regionsRead more

day: Conference Day Two