Suman Jangid

Company: Bridge Bio

Job title: Director Global Regulatory CMC

Seminars:

Fireside Chat: Analyzing the Most Recent FDA Draft Guidance on Potency Assays to Navigate Differences & Obstacles 11:45 am

Comparing the newly released draft guidance with previous versions Removing uncertainties stemming from the draft guidance to determine clear next steps Discussing strategies for updating and aligning potency assay techniques with the new guidanceRead more

day: Conference Day Two

Cultivating a Global Perspective on Regulation to Unveil the Similarities & Differences in Regulation Across the World to Simplify Application Processes in Regions Outside the USA 8:02 am

With many companies preparing for global expansion of their cell and gene therapies, clarity in regulation across the USA, Europe, UK, Australia, Canada, Japan, and South America is paramount to this journey. Whilst there is much similarity between regulatory body requirements, this session aims to highlight key differences to foster understanding and provide solutions to…Read more

day: Pre-Conference Workshop Day