Considering the international emergency due to COVID-19, the Benelux Pharmacovigilance Conference will be postponed to 2021.
The new date will be available soon.
“Safety and Pharmacovigilance” increasing Awareness of Significant and Essential Needs in Benelux Countries
The 4th Benelux Pharmacovigilance Day conference will be the opportunity to discuss, deliberate and debate the latest operational and technological challenges in the Pharmacovigilance (PV) and drug safety field. Recent advances and perspectives in PV and drug safety in clinical trials will be shared during the meeting, with an emphasis on practical aspects and how-to. This event brings together the relevant experts to share their experience in the field using practical examples. This will trigger engaging discussions and will guide participants’ efforts in the jungle of currently available methods. The objective is to help find solutions to multiple challenges that, as a cross-functional development team in PV, must solve to maximize new opportunities ahead.
This year’s event focuses on hot topics that have major impact on Safety and Pharmacovigilance related processes and activities such as, but not limited to:
- New inspection mood and audit feedback (PV quality compliance linked to new AI tools)
- New medical device regulation: Impact on safety reporting
- Safety reporting in drug-device combination
- AI in Literature monitoring, new tools
- Assessment of effectiveness of risk Minimization Measures
- Big Data in PV- Signal management
- QPPV challenge & emerging trends linked to Brexit
- New PV tools, Machine learning and AI (data protection and Signal detection – requirements, challenges and compliance) how to capture safety concerns?
- Clinical Trial regulation (CLINICAL TRIALS REGULATION (EU) NO 536/2014 Q&A document)
- PV requirements for health supplements or alternate therapies
During this one-day forum we will provide and discuss the best solutions to help drive success in your organization.
Elena Prokofyeva – Head of Drug Safety Unit at FAMHP
Leanne Walsh - Global Director, Drug and Device Safety Services at Covance
Parminder Kaur - CEO & EU QPPV at RegPak BioPharma Consulting
Who should attend?
This conference is designed to benefit functional/technical professionals working in the pharmaceutical and health care area dealing with the Pharmacovigilance system, such as: Safety and Pharmacovigilance dept, Clinical operation dept, Statistic dept, Medical Affairs dept, Medical Information dept, Regulatory Affairs dept, Quality & Compliance dept, Legal dept, Software Developing dept, Medical Devices Manifacturing Companies, University Faculties scientists who are related to clinical and medical research (Senior, Associate and Assistant Professors, Research Scholars, Phd students). Also, Directors/Seniors Directors/Executive Directors and Vice Presidents /Senior Vice Presidents/Executive Vice Presidents and Heads/Leaders/Partners of: CROs and CMOs, Clinical Research Sites, Pharma, Biotech and Medical Devices Industries.