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.

Keywords:

Speaker

Dr. Kosta Cvijovic, EU QPPV, Syneos Health

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).

Message Presenter

Who Should Attend?

This webinar is for professionals who are involved in:

Preparing or contributing to EU RMPs
Preparing or contributing to PBRERs
Preparing or contributing to PSMFs
The EU QPPV Office

What You Will Learn

Attendees will hear about:

An overview of the current Module V of the GVP
Changes resulting from Revision 2
Practical applications of Module V through case studies
Benefits and challenges of risk removal and/or adaptation
Changes to the modular system of the GVP documents

Xtalks Partner

Syneos

Our safety and pharmacovigilance teams support clinical trial and post-marketing safety surveillance across the globe. With patient safety as the critical component in product development, our quality focus aligns us to partner with our customers to provide both standalone and integrated services throughout the life cycle of a product.

What sets us apart is our people: highly qualified drug safety scientists and skilled healthcare professionals with experience in direct patient care, industry-specific pharmacovigilance services and a deep knowledge of regulatory legislation and dedication to providing quality safety services.

We manage your safety and pharmacovigilance needs at any stage of product/device development to ensure quality and compliance:

Clinical trial safety: Phase I-IV, from data entry to case closure, full processing, including expedited/periodic reporting
Post-marketing safety: AE case processing, reporting, signal detection, U.S.-based call center, literature search and review, product complaints, EU QPPV and Litigation case processing
Safety regulatory submissions: Dedicated subject matter experts in safety regulatory legislation and submissions
Safety physicians: We have dedicated/trained physicians in all aspects of the life cycle of safety and pharmacovigilance
Safety database: Dedicated support team with expertise in working both in customer and in-house safety database