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FDA’s Marks and Shuren to speak at RAPS Convergence opening

Posted 22 June 2021 | By Zachary Brousseau 

FDA’s Marks and Shuren to speak at RAPS Convergence opening

Peter Marks and Jeffrey Shuren

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.

 

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