Session Details

Chair:

• Margareth Jorvid, MSc Pharm, MSc MTRA, MBA, Methra Uppsala AB, Sweden

Speakers:

• Patrick Celis, PhD, European Medicines Agency (EMA), Netherlands - The Regulator role and EMA support to CGT product development 
• Miguel Forte, MD, PhD, mC4Tx, Belgium - Key consideration and preparation for interactions with Authorities during CGT product development
• Anna Koptina Gültekin, PhD, Mendus AB, Sweden - Regulatory milestones and clinical progress of vididencel and ilixadencel in the treatment of AML and solid tumours – a case study

Clear communications with regulators during the development of a drug product is essential to success. This session addresses the European viewpoint of when and how to interact with your regulators through the product lifecycle and the different pathways to market.

1. An understanding of the drug developer:regulator relationship in cell and gene therapy development.
2. A description of the product lifecycle and role of the regulator during its development from inception to commercialisation.
3. An appreciation of the different routes to market and the best path to take dependent on disease and drug product