Date: 23 October 2025

Time: 18:00 - 21:00

Venue: Magdalen Centre (Thames Room), Robert Robinson Ave, Littlemore, Oxford OX4 4GA, United Kingdom

The recent publication of FDA Complete Response Letters (CRLs) has shed light on persistent Chemistry, Manufacturing, and Controls (CMC) challenges that continue to hinder regulatory approval.

This event brings together experts to dissect recent CRLs, clarify the key themes regulators are emphasizing, and discuss strategies for proactively closing compliance gaps. Through candid conversations and peer exchange, you’ll gain practical insights into how to interpret regulatory feedback, strengthen CMC submissions, and minimize the risk of costly delays.