About ISoP - Advisory Board 2016 - 2019 - Biographies
Board Member, ISoP
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 17 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 has established guideilnes and registries for PASS at national level back in 2003, and since then he was involved in development of standards and regulations surrounding non-interventional studies in safety areas.
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.
His recent main activities include provision of QPPV services, pharmacovigilance audits and inspections, development of risk management plans, and optimisation of pharmacovigilance systems. He leads PharmInvent as CEO, and is a Board Member and President of PrimeVigilance.
Jan is an active trainer for number of DIA international pharmacovigilance courses, and serves at the Advisory Board of International Society of Pharmacovigilance
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