The founder and director of the Institute of Pharmacovigilance is a highly visible figure in the pharmacovigilance world for over 20 years.
Dr. Jan Petracek qualified as a physician from Charles University in Prague and holds a Master of Science with Distinction in Quality and Safety in Healthcare from Imperial College London.
Twenty years in pharmacovigilance
Jan has enjoyed over 20 years of intensive work in all areas of pharmacovigilance, being former Head of Risk Management Section at the European Medicines Agency, Head of Pharmacovigilance in the Czech Republic, Head of Strategy and Development of the Czech National Authority, and member of CHMP Pharmacovigilance Working Party, CEO of PharmInvent and PrimeVigilance, and Board Director of a public company in London.
He was trained and contributed as an inspector within the Benchmarking of the European Medicines Authorities, assessing performance of regulatory authorities in the EU and helping to set benchmarks for regulatory approaches and performance. He also audited dozens of pharmaceutical companies, resulting in significant improvements of their pharmacovigilance systems.
Developing the guidelines
Jan took part in the development of national, European, ICH and CIOMS guidelines. One highlight of his contribution was the EMA Guideline on Safety and Efficacy Follow-up - Risk Management of Advanced Therapy Medicinal Products, which was so visionary that even after 13 years it is still highly effective as it predicted future safety issues and suggested lasting solutions. He also enjoyed international regulatory diplomacy while representing the EU at the ICH E2F Expert Working group on Development Safety Update Reports.
He contributed to the development of new regulatory pathways as a member of the EMA Innovation Taskforce, including biosimilars, nanomedicines, and challenging combination products. He assessed borderline products and OTC switches and often found fresh new solutions to difficult questions.
Still improving the pharmacovigilance industry
Jan is a very active trainer on international courses and is an elected member of the Advisory Board - International Society of Pharmacovigilance. He also worked as EU QPPV for major innovative companies, performed complex audits, strategic consultancy, and has led fast growing organizations as entrepreneur and CEO for the last 10 years.
Jan is now dedicated to the building of the Global Pharmacovigilance Professional Certification, leading the Special Interest Group on the Pharmacovigilance Qualification Framework of ISoP, Scoping Group of ISoP, and many associated collaborations.