About ISoP - Advisory Board 2019 - 2022 - Biographies

Dr Jan Petracek MD MSc DIC

ISoP Board Member

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.

Jan has over 19 years of experience in all areas of pharmacovigilance, being former Head of Risk Management Section at 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.

He was trained as the 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 participated in development of several national, European, ICH and CIOMS guidelines. He was the lead author of the EMA Guideline on Safety and Efficacy Follow-up – Risk Management of Advanced Therapy Medicinal Product, and member of the ICH E2F Expert Working group on Development Safety Update Reports.

He contributed to development of new regulatory pathways as a member of the EMA Innovation Taskforce, including biosimilars, nano medicines, and challenging combination products.

Jan is a very active trainer for number of DIA international pharmacovigilance courses and is an elected member of the Advisory Board – International Society of Pharmacovigilance. He also works as EU QPPV for major innovative companies, performs complex audits, strategic consultancy, and leads fast growing organizations as entrepreneur and CEO for the last 9 years.

Declaration of Interest Download PDF