Dr. Axel F. Wenzel

Dr. Axel F. Wenzel

Chief Scientific Officer and Director: Dr. Axel F. Wenzel, PhD; MSc; BSc; FTOPRA

Dr. Axel F. Wenzel is Chief Scientific officer (CSO) and Director of EU Vigilance Ltd. in our German office (and in addition CEO of P.SS.T Pharma Scientific Services Team, a consulting and service provider for drug development and post marketing services.)

He earned a PhD (Dr rer nat) in life sciences and a Masters degree (Diplombiologe) in Microbiology at the University Saarbrücken (Germany) and Innsbruck (Austria).

He has more than 25 years scientific and professional experience: basic and clinical microbiology, pharmacology and toxicology, pharmaceutical R&D, project management in drug development, drug regulatory affairs and pharmacovigilance. Wenzel´s medical expertise and operational routine is complemented by a thorough understanding of global and EU pharmacovigilance system requirements.

After ten years in various management positions at the Sandoz Research Institute in Vienna, Austria, he served for seven years at MSD, Germany, as head of New Product development with additional EU wide functions. Thereafter he established the P.SS.T consultancy and later he co-established EU Vigilance Ltd.

Axel is experienced in many fields of Health Care product safety, e.g.

  • as pharmaceutical QPPV on a national level
  • as approved XEVMPD data base user
  • as responsible person for medical device vigilance
  • as manager for technical complaints of medical devices
  • in safety evaluations of medicinal drugs, medical devices, cosmetics etc.
  • in all risk management issues for medicinal products as well as in medical devices
  • in writing RMSs, PSURs, DDPSs (RSMFs) etc.

For many years he served as Board member of TOPRA (The Organisation for Professionals in Regulatory Affairs (2005-2008 as President) and Co-founder + editor in chief of the leading regulatory affairs journal “Regulatory Rapporteur” and he is still a member of TOPRA’s pharmacovigilance SPIN group. He also served as President of PEFRAS (Pan European Federation of Regulatory Affairs Societies) and MEGRA (Mid European Society for Reg. Affairs Professionals). Actually he holds the function of a 1st Vice President of the European Association of Pharmaceutical Biotechnology and chairs its Regulatory and pharmacovigilance special interest group.

Axel Wenzel has been, since 1996, a lecturer at the University of Essen for Drug Regulatory Affairs, Clinical Research and project management and at the German University for Professional Studies (DUW, Deutsche Universität für Weiterbildung; FU Berlin) he is a lecturer in the postgraduate course „Drug Research and Management”. He has developed, chaired and ran various training courses for industry and agencies on pharmacovigilance and drug development subjects (eg. TOPRA CRED courses, MEGRA basic courses).

He has published more than 70 scientific articles, columns and contributions to scientific books. See more in Publications.