Overview
Are you aware of the key developments on the benefit-risk guidelines?
Benefit-risk guidelines continue to evolve with the EMA publishing guidance revisions as recently as this March. This workshop provides you the tools to address these changes by giving you:
- Overview of benefit-risk assessments
- Examples of challenges and solutions across different departments
- Impacts and interpretations of the new guidelines
EMA experts join this workshop to give you tangible insights and tips to navigate the evolving benefit-risk guidelines. The hands-on workshop structure provides you with real-world examples from regulatory and industry perspectives, and explores tangible ways to improve your best practices.
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Program Committee
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Martin Huber, MPH, MPharm Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair
Federal Institute for Drugs and Medical Devices (BfArM), Germany -
Steve Mayall, PhD Director
Huron Consulting Group, United Kingdom -
Jan Petracek, MD, MSc CEO
Ivigee, Czech Republic -
Steffen Thirstrup, MD, PhD Chief Medical Officer
European Medicines Agency, Netherlands
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