Top FDA and EMA officials to kick off Convergence 2021
RAPS will hold its annual Convergence, the world’s largest conference dedicated to healthcare product regulation and regulatory issues, 12–15 September. Convergence 2021 will be a live, virtual event featuring more than 100 educational sessions, presentations, panel discussions, speaker and author meet and greets, and other interactive sessions with more than 200 expert speakers.The four-day conference will kick off with an opening plenary and panel discussion on COVID-19, regulatory affairs, and the impact on patients, featuring Acting US Food and Drug Administration (FDA) Commissioner Janet Woodcock, MD; FDA Center for Biologics Evaluation and Research (CBER) Director Peter Marks, MD, PhD; FDA Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren, MD, JD; and Alexis Nolte, head of the Human Medicines Division of the European Medicines Agency (EMA).
“Over the past year and a half as the world faced a historic public health crisis, the role of regulatory professionals has never been more critical,” said Convergence Planning Committee Chair Meg Mucha, MJ, RAC, FRAPS, CQA, director, Q & R audit and compliance, Philips Healthcare. “As the premier event for the regulatory profession, Convergence is an essential forum for regulators; healthcare innovators; pharmaceutical, biotech and medical device regulatory affairs leaders; senior executives and other stakeholders to share experiences, exchange ideas, get updates and discuss trends at this pivotal time.”
Attendees will hear from more than 50 speakers representing national and regional health authorities and notified bodies from Europe, Canada, Brazil, Japan and the US—including more than 25 from FDA alone—as well as myriad global thought leaders from healthcare and the life sciences.
Highly anticipated topics on the conference agenda include accelerating drug development, artificial intelligence in medical technology, postmarket surveillance and patient safety, real-world evidence, best practices for interactions between regulators and regulated industry, medical device cybersecurity, cell and gene therapy regulation, global regulatory and clinical strategy, successful remote work, risk management, crisis management, regulatory intelligence, and more.
This year’s Convergence is expected to draw around 1,500 participants from around the globe for a live, virtual, interactive experience. In addition to educational and informational sessions, the conference also offers attendees opportunities to connect virtually with 30 sponsor solution providers, peer-to-peer networking, wellness breaks and live entertainment.