Anamitro Banerjee

Company: AstraZeneca

Job title: Director, CMC Regulatory Affairs

Seminars:

Case-Study: Bridging Clinical Phase I to III Studies for Small Molecule Development to Demonstrate Quality Consistency & Safety 9:00 am

Understanding how to use a bridging study to communicate process similarity to health authorities and regulators for streamlined approval Outlining the use of modelling to aid bridging studies for similarity demonstrations for maximal efficiency Pinpointing data and cost limitations for large biologics and using this as a decisionmaking tool to explain when is best to…Read more

day: Conference Day Two