Anastasia Yemelyanova

Company: Spark Therapeutics

Job title: Director of Regulatory CMC

Seminars:

Exploring Different Approaches & Expectations in Proving Comparability in a Global Setting 10:00 am

Clarifying the FDA Expectations on Repeat Studies for Non-Clinical Studies Between and Before Phase 3 Exploring Different Global Approaches to Comparability between the FDA, EMA and other Regulatory Bodies Understanding the Depth and Timelines Needed for Comparability Data as Gene Therapy Programs progress to phase 1 and 2 When Resource Burden IncreasesRead more

day: Conference Day Two