Dr Gertzen became Director after being the Regional Director for Clinical Quality Assurance of Development Activities in Europe, Africa, and Middle East. Since 2010 he is Sanofi R&D Quality Intelligence Leader. Dr Gertzen has a MSc and PhD degrees in Experimental/Mathematical Psychology of University of Heidelberg.

Noémie Manent is the Operations Lead in the Clinical Trial Transformation team at the European Medicines Agency, facilitating change management for member states and sponsors with the implementation of the clinical trial Regulation. She has played an essential role in the set up of structured summary results for clinical trials. Also, she has experience in the coordination of inspections for marketing authorisation application. Noemie has more than 15 years experience working in clinical R&D for small and medium enterprises in industry and academia mainly in France and the United Kingdom.

Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing and personal data protection in health research on medicines. He joined the EMA Inspections Service in 1999, and became Head of Compliance and Inspections (2009) and Head of Division Inspections and Human Medicines Pharmacovigilance in 2013 (including Scientific Committee Services from 2016). He has a BA (Physiology 1979) a Dr de 3eme Cycle (cancer biology 1982), and PhD (Pharmacology 1986). Fergus worked in clinical research mainly in QA from 1982 to 1999.

Mrs. Van de Voorde qualified as a pharmacist. She is also registered as “lead assessor” in the “International Register of Certified Auditors”. Kristel Van de Voorde is part of the faculty of the DIA GCP Compliance course since 1995.

Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having previously had a split inspection role between the GCP and Laboratories teams. As an Expert Inspector his role includes the provision of technical leadership, guidance and support. Jason has a degree in Biomedical Science and a Postgraduate Diploma in Pharmaceutical Technology & Quality Assurance. Previously Jason spent seven years in the UK National Health Service working in hospital pharmacy (including clinical trials & manufacturing).

Vincent has been the GCP Operations Manager since July 2008. He joined the MHRA in September 2005 as a GCP Inspector. He worked in NHS for 17 years as a clinical trial pharmacist before joining the MHRA. He is an honorary Senior Lecturer at the School of Pharmacy, University of London.