OXON’s Free Live Online Webinar Series on RWE
'Unlocking Success: Mastering RWE Studies in the Healthcare Landscapes of Asia, Europe & the US'
Session 7 - Mastering real-world RMM & Controlled-Access Studies
Thursday, 13 March 2025 at 5pm CET
SPEAKERS:
Professor Antoine Pariente
Professor of Pharmacology, Pharmacoepidemiology and Pharmacovigilance at the University of Bordeaux (ex-PRAC member)
And
Nawab Qizilbash MRCP(UK) MSc DPhil(Oxon)
Senior Clinical Epidemiologist, OXON
Hon. Associate Prof., London School of Hygiene and Tropical Medicine
Clinical Observer, Madrid and Formerly Hon. Consultant Physician, Oxford.
Risk Minimisation Measure (RMM) studies and controlled access programmes (CAP) require a specialized set of skills that go beyond traditional epidemiological approaches. Researchers must tackle the intricate challenges of evaluating, implementing, and optimizing RMMs and CAPs to ensure patient safety and regulatory compliance. This session is designed to provide you with the tools and insights to successfully design, execute, and interpret real-world RMM studies and CAPs.
In 60 minutes, gain actionable knowledge on the methodologies and strategies critical for conducting effective RMM evaluations and CAPs . Learn how to apply these approaches in real-world settings, from understanding regulatory expectations to optimizing study and CAP outcomes.
Key topics include:
- What makes RMM studies unique?
- Recent updates in Good Pharmacovigilance Practices (GVP)
- Practical considerations and challenges in RMM survey studies
- Insights from European regulatory feedback
- Criteria for selecting effective data sources
- Navigating the scientific and logistical hurdles
- Practical considerations and challenges with CAPs
- Interactive Q&A session