Founder of the Institute of Pharmacovigilance
Dr. Jan Petracek is a qualified physician from Charles University in Prague and holds a Master of Science degree with Distinction in Quality and Safety in Healthcare from the Imperial College London.
Former Head of Risk Management Unit at the European Medicines Agency, former Head of Pharmacovigilance, Strategy and Development at the State Institute for Drug Control in the Czech Republic and a former member of PhVWP, Signal Management Task Force, Innovation Task Force, ATMP Implementation Task Force, CIOMS and ICH. His professional expertise combines experience of a senior regulator, senior consultant, EU QPPV, auditor, and successful entrepreneur in pharmacovigilance services.
Today Jan is the COO and member of the Board of Directors of Ergomed plc, and the CEO of PharmInvent and PrimeVigilance, renowned expert companies providing Regulatory Science and Pharmacovigilance services to clients worldwide.
Since 2004 he was also appointed as a trainer for DIA, ISoP and ICH approved pharmacovigilance courses.
Jan has participated in the development of several national, European, ICH and CIOMS guidelines. He is the lead author of the EMA Guideline on Safety and Efficacy Follow-up - Risk Management of Advanced Therapy Medicinal Product, and a member of the ICH E2F Expert Working group on Development Safety Update Reports.