Pharmacovigilance Strategies Workshop
30+ confirmed speakers, including regulators, representatives from national authorities and the industry are key stakeholders in the field and will provide guidance and practical recommendations for you to bring back to your team and company.
- Pharmacovigilance Inspections & Audits: Joint inspections are now a reality! Hear directly from the first company to be subjected to one and know what to watch out for in your own company.
- Impact of the Clinical Trial Regulation: The European Commission has recently released the Q&A report on safety information regarding Clinical Trials. A top CTFG representative will explore this in detail so that you can fully understand the impact on your daily work in PV.
- Medical Device Regulation - Impact on PV: Be among the first to explore the impact of the new Medical Device Regulation in the PV world. What changes does it/will it bring for you?
- Signal Management: Discuss Signal detection in EudraVigilance, eRMR assessment for Generics, Innovator perspectives on signalling & more.
- Post-Authorisation Safety Studies &Registries: Hear about Patient Disease Registries, the impact of non-European PAS on European PV systems, and results from post-authorisation studies
- Risk Minimisation Measures & Safety Communication: A Regulator’s perspective on risk communication, Controlled Access Programmes, and aRMM effectiveness are on the menu.
- The Future of Pharmacovigilance: Where do we need new standards, and where is guidance too strict? How far are we with automation and AI? These are just some of the questions to be explored.