Welcome!

The purpose of the CMC Strategy Forum Europe 2020 is to offer a blend of topics that characterize the challenges facing the biotechnology industry in the next decade. This Forum focuses on relevant CMC issues throughout the lifecycle of a product and thereby fosters collaborative technical and regulatory interactions. The Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Europe. The EFPIA MQEG Biomanufacturing Satellite Session will include concept paper updates on polysorbates and antibody drug conjugates, as well as a session on AAV: Current Status, Manufacturing Challenges and Opportunties. The technical sessions will be: Bioassay Capabilities and Applications for Therapeutic Monoclonal Antibodies; Applying Patient-centric Quality Standards Concepts to Biotechnology and Advanced Therapy Products; ICH Guideline Updates and Discussion: Q5A(R2), Q12 and Q13; and The Use of Next Generation Sequencing to Characterize and Detect Adventitious Viral Agents in Biological Products.

To accommodate our global community, we made the decision to condense each session and keep the program length to three days. Each session will still include live speaker presentations and panel discussions. This means that you will have the opportunity to login and view each session, ask questions of the speakers and panel members, as well as interact with other attendees.