Friend or Foe: How COVID-19 Changed the Dynamic with Global Regulatory Agencies
3:30 PM - 4:30 PM (EDT), Monday, June 5, 2023 ・ Session Room 204AB
COVID-19 lit a fire under global regulatory systems, triggering regulatory bodies and pharma companies to prioritize and streamline their development efforts. While regulation may help to ensure safe medicines, the pandemic’s accelerated vaccine development and approval processes prompted concerns about perceived ethical and regulatory shortcuts. Despite the industry’s commitment to safety and efficacy, fast-tracked R&D and market authorization bred hesitancy toward COVID-19 vaccines, impacting vaccine access and uptake. In this session, experts will explore the regulatory challenges underpinning the swift roll-out of COVID-19 vaccines, resulting obstacles in vaccine confidence and adoption, and opportunities for better collaboration between sponsors and regulators at the forefront. With an increased understanding of COVID-19 through real-world evidence, these learnings and evolving partnerships present an opportunity to carry lessons learned forward for future treatments and technologies.
Director, Center for Biologics Evaluation and Research (CBER)
U.S. Food and Drug Administration
Principal Scientific Administrator, Stakeholders and Communications Division
European Medicines Agency (EMA)