PrimeVigilance is pleased to share the news that Dr Jan Petracek (PrimeVigilance CEO, and former Head of Risk Management at EMA) was honored to be invited as a speaker at the 2019 APEC LSIF RHSC Center of Excellence in Regulatory Sciences Pilot Workshop on Pharmacovigilance, which was held April 23-25 at Peking University in Beijing, China.

Dr. Petracek shared his experience and knowledge on three topics: ICSR Assessment plus a Case Study, Benefit Risk Assessment through Product Lifecycle plus lead a Group Discussion about how to Evaluate Appropriate Risk Management Plan. By sharing his knowledge and experiences, Dr Petracek is hoping to help tackle current and future challenges in health products regulation.

This CoE was set up with great support from the APEC Regulatory Harmonization Steering Committee (RHSC), the China National Medical Products Administration (NMPA), Peking University, and related government agencies and industry organizations, to 1) promote regulatory convergence (harmonization), capacity and cooperation for health related products; 2) to leverage the development of guidance and criteria in regulatory sciences in China. As part of Peking University, the CoE provides a neutral academic platform for regulatory stakeholders to come together for the sharing of knowledge and experiences in tackling current and future challenges in health products regulation.

For more information and the program please visit the APEC website




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