Gabriele Schwarz, licensed pharmacist, has been employed at the Federal Institute for Drugs and Medical Devices (BfArM) since 2001.
Since the beginning of 2023, she dedicates her expertise and resources to regulatory activities at European and international level. She currently represents the EU member states in the ICH E6(R3) Expert Working Group, which is drafting a revision of the GCP guideline. At the same time, she contributes to several Priority Actions of the Accelerating Clinical Trials in the EU (ACT EU) Initiative, a joint project of the Commission, the EMA and the Heads of Medicines Agencies, which aims to modernise the European framework conditions for clinical trials and better meet the needs of patients and trial participants.
Until the end of 2022, she was Head of the GCP Inspectorate at BfArM and her responsibilities entailed the planning, coordination and implementation of BfArM’s GCP inspection activities, mainly in the context of the European marketing authorisation procedures for medicinal products.
From 2002 – 2022 she was also an appointed member of the GCP Inspectors Working Group (GCP IWG), which is hosted and chaired by the European Medicines Agency (EMA), and was actively involved in a high number of sub-groups and the development of regulatory guidelines.
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