Ilya Shestopalov
Company: bluebird bio
Job title: Vice President, Analytical Development & Product Lead
Seminars:
Contrasting FDA vs EMA Experiences to Cement European Regulatory Strategy 9:05 am
One of the biggest challenges is navigating the regulatory frameworks, especially with FDA holds on release and potency assays. This workshop will explore the contrasting experiences of these two regulatory bodies, and provide insights into the challenges of assay development and validation in cell therapy potency testing. Attend this workshop to: Identify the challenges of…Read more
day: Pre-Conference Workshop Day
Outlining Strategies for Communicating Potency & Stability Data to European Regulatory Agencies 3:00 pm
Recounting best practice when communicating potency and stability data to European regulatory agencies to ensure product safety and compliance Highlighting common pitfalls and how to avoid them when presenting potency and stability data to European regulators Transferring an in vivo assay to in vitro and evaluating the limitations of European culture proceduresRead more
day: Conference Day Two