Risk Management Plans: GVP Module V Revision 2 and Its Local Impact in the EU

Module V of the Good Pharmacovigilance Practices (GVP) of the European Medicines Agency (EMA), which governs Risk Management Plans (RMPs) and Systems, has gone through a significant overhaul with its second revision. One of the most important aspects of this update is the possibility to remove risks from RMPs, provided that it can be demonstrated to the authorities that these are adequately managed. This issue does not always arise with central authorities like the EMA but can affect approvals of local EU authorities as well.

In this free webinar, the featured speaker will review the current Module V of the GVP, discuss changes resulting from Revision 2 and demonstrate its practical applications through case studies, both when it comes to interactions with the EMA as well as local authorities such as the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). Special focus will be put on data and arguments for risk removal and/or adaptation, the success rate of such an approach, as well as the change in the modular system of the GVP documents which no longer necessarily makes Periodic Safety Update Reports’ (PSURs’)/Periodic Benefit-Risk Evaluation Reports’ (PBRERs’) and RMPs risk sections fully exchangeable.

Dr. Kosta Cvijovic has six years of experience in a clinical research organization (CRO) as a director of pharmacovigilance & medical information and as the European Union Qualified Person for Pharmacovigilance (EU QPPV). Dr. Cvijovic also has 10 years of experience in companies such as Pfizer, Novartis and small biotechs, with positions up to and including head of global pharmacovigilance and EU QPPV. Dr. Cvijovic has three years of experience working with Health Canada as a research fellow and one year of experience working as a clinical pharmacist. Among others, Dr. Cvijovic was able to improve the PV system of one of his past employers to the point that a previous failed inspection was passed during re-inspection. Additionally, he has led and passed several PV inspections from authorities such as the US Food and Drug Administration (FDA), Health Canada, UK Medicines and Healthcare Products Regulatory Agency (MHRA), French ANSM and German BfArM.

His therapeutic area experiences include oncology (ALK-positive NSCLC, leukemia), central nervous system (ALS), cardiology (pulmonary hypertension) and biosimilars (rheumatoid arthritis).