Online meeting

Speaker: Annelies Inzé, PhD – Regulatory Affairs Team Leader – Pfizer

Advanced Therapy Medicinal Products (ATMPs) are a fast-growing field of innovative medicinal therapies that have the potential to bring highly transformative value to patients, including potential cures, by either correcting the underlying cause of their disease (e.g. a genetic defect) or by modifying a function in the body to cure or significantly ameliorate their disease. Some ATMPs, such as gene therapies, are classified as Genetically Modified Organism (GMO) and therefore are subject to the EU GMO legislation. Investigational medicinal products containing a GMO (GMO-IMP) constitute a special regulatory case, as these IMPs are, in addition to the standard review of a CTA application and the Ethics Committee review,  subject to a separate assessment and approval process, to ensure protection of persons (including non-patients), as well as to permit the release of the GMO-IMP into the environment.

During this session, an overview will be provided of both the overarching European GMO legislation as well as the GMO regulatory framework and procedures in Belgium and how this impacts the Clinical Trial Application process for gene therapy clinical trials in Belgium.