The GPPC: ISoP's Global Pharmacovigilance Professional Certification

14^th International Conference on Pharmaceutical Education and Practice

October 28, 2022 | Webinar

Jean-Christophe Delumeau

Institute of Pharmacovigilance, Canada

Posters & Accepted Abstracts: Biomedical & Pharmaceutical Sciences

Abstract :

The core mission of the Institute of Pharmacovigilance (IPV), a non-profit NGO, is to develop and deliver the Global Pharmacovigilance Professional Certification (GPPC) in partnership with the Internal Society of Pharmacovigilance (ISoP). This programme is based upon a Pharmacovigilance Career Framework Guideline developed by ISoP’s Special Interest Group on PV Professional Qualification. For the identified roles matching existing jobs and positions, competency standards are established. Qualified Person for Pharmacovigilance (QPPV) was identified as the most suitable model for implementing the GPPC programme. The examination process uses sets of Multiple Choice Questions (MCQs) substantiated by a comprehensive Knowledge Management System (KMS). Subject Matter Experts (SMEs) elaborate batches of MCQs following a consistent, standardised methodology. Subsequently, those batches are reviewed and checked for quality by professional MCQ-making specialists, then endorsed by professional MCQ-making specialists. Candidates are evaluated during online testing sessions. The testing platform, including a proctoring solution using artificial intelligence, was selected and adapted to the specificity of the GPPC. For specific roles, the required skills are tested via real-life scenarios that candidates need to address, followed, for the most senior roles, by an oral examination. ISoP-certification is granted upon completion of the examination process. The whole process is managed by IPV with the contribution of recognized ISoP experts appointed regionally. Considering the nature of the GPPC project and its component aimed at characterising the PV-relevant regulatory component, collaboration with National Regulatory Authorities is essential.

Biography :

Jean-Christophe Delumeau graduated in Medicine and neuropharmacology from Rennes and Paris-Sorbonne universities. After residency in hospitals and French Institute of Medical Research, he moved to clinical research conducting multinational clinical trials in neurology from Basel, Paris and Tokyo. From 2002, he led pharmacovigilance departments in Asia-Pacific based in Osaka, Beijing, then Singapore. In 2017, he moved to a global-scope Pharmacovigilance Policy Strategy position. In 2022 he joined the Scientific Board of the International Society of Pharmacovigilance (ISoP) and was appointed Boad Director of the Institute of Pharmacovigilance the NGO developing ISoP’s Global Phamacovigilance Professional Certification.