Monika Pietrek

Company: Pietrek Associates GmbH

Dr. Monika M. Pietrek is a medical doctor and epidemiologist with more than 25 years of experience in international drug development and post-authorization safety monitoring/risk management. She has worked in clinical care, pharmaceutical and CRO industries as well as at the German regulatory agency responsible for vaccines and biologics.

Dr. Pietrek is the founder of Pietrek Associates GmbH, an independent consultancy firm to the pharmaceutical and biotechnology industry. Her team has contributed to several marketing authorisation applications, risk management and pharmacovigilance projects as well as more than 300 GCP/GVP audits and mock inspections.

For more than 10 years she has been co-chairing the EU Pharmacovigilance (PV) Working Group of industry experts. In this capacity Dr. Pietrek has been involved in the development and review of the EU PV legislation since the public consultation in 2006. She has published about Good Pharmacovigilance Practices, the PV terminology and the new EU PV legislation and PV quality management.

Dr. Pietrek has served as DIA volunteer for more than 20 years, as a speaker, session chair, theme leader and as a member of various programme committees for the annual conferences and workshops in North America and Europe, the Continuous Medical Education Committee and the Advisory Council Europe. She is a member of the Editorial Board of the Therapeutic Innovation and Regulatory Science (TIRS) Journal.

Since 2010 Dr. Pietrek has been coordinating and teaching the PV Module of the MSc in Regulatory Affairs for Biopharmaceuticals ( in collaboration with the University of Strasbourg.

Her interests are benefit/ risk assessments of medicinal products and process optimisation in clinical research and pharmacovigilance, balancing solutions to meet patient needs and public health decisions as well as to support innovative drug development. More details are available on