FDA Directors Peter Marks and Jeffrey Shuren to Speak on COVID-19 and Regulation at RAPS Convergence Opening


Rockville, MD, USA, June 22, 2021 (GLOBE NEWSWIRE) — The Regulatory Affairs Professionals Society (RAPS) today announced that two of the US Food and Drug Administration’s (FDA) top officials will appear on a panel during the opening plenary kicking off RAPS Convergence 2021. Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research (CBER), and Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health (CDRH), will join a discussion on COVID-19, regulatory affairs, and the impact on patients, on 12 September—the first day of RAPS’ signature annual event.

“Not only are Peter Marks and Jeffrey Shuren experienced and respected regulators, but both have also been key figures in FDA’s response to the COVID-19 pandemic,” said Kimberly Belsky, MS, executive director, regulatory policy & intelligence, Mallinckrodt Pharmaceuticals. Belsky also serves as vice chair of the RAPS Convergence 2021 planning committee and will be the moderator of this panel discussion. “At CBER, Dr. Marks has overseen efforts that have made safe, effective COVID-19 vaccines available to the American public. And at CDRH, Dr. Shuren helped streamline the emergency use authorization process for new COVID-19 diagnostics that have been invaluable to healthcare professionals and patients.”

“We are thrilled for the opportunity to hear directly from Dr. Marks and Dr. Shuren, and to get their insight on lessons learned from FDA’s response to the pandemic,” said Convergence Planning Committee Chair Meg Mucha, RAQA executive, IBM Watson Health.

Designed exclusively for regulatory professionals by regulatory professionals, RAPS Convergence 2021 convenes virtually 12–15 September and is the largest annual regulatory-focused event in the world. The event unites key stakeholders and decision makers across all intersections of the regulatory field for four powerful days of professional development, interactive discussions and relationship building.

Members of the media who wish to cover all or part of RAPS Convergence should contact Zachary Brousseau, senior manager, communications, RAPS, at zbrousseau@raps.org.

About RAPS

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with chapters and affiliates worldwide. www.RAPS.org


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