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.
Who should attend?
Professionals involved in benefit-risk strategy from various departments, e.g. pharmacovigilance, regulatory, clinical, drug safety, medical affairs, or medical writing.
Program leads who oversee the clinical development, dossier preparation, and post-marketing phases of the medicines life cycle.
What will you gain?
New benefit-risk regulations call for a more structured and formalised process. This workshop will:
- Increase your understanding of the current benefit and risk landscape
- Empower you to perform benefit-risk management more effectively within your organisation
- Create a toolkit for you to address tactical components of risk assessments, including data collection and digital innovation
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