This webinar focuses on benefit-risk management and evaluation and managing evolving regulatory safety standards. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are increasingly moving from a separate safety and effectiveness assessments model to combined benefit-risk assessments. Both the EMA and the FDA are making transparency a priority, proactively seeking the viewpoints of patients and other stakeholders, striving for optimum safety integration into the healthcare system and assessing a medication's real-world value by examining and optimizing its benefit-risk trade-offs in populations and sub-populations. This shift in approach provides challenges and opportunities in addressing these evolving requirements, as regulatory agencies increasingly look at safety through the lens of a benefit-risk balance, addressing both benefits and risks.
Speakers: Dr. Stella Blackburn, Vice President, Global Head of Risk Management, Real-World & Late Phase Research, Quintiles and Mary Mease, RPH, MPH, Senior Director, Benefit-Risk Management, Quintiles