FDA Commissioner Scott Gottlieb’s Keynote Among Highly Anticipated Sessions at RAPS Regulatory Convergence

Posted 10 August 2017 By Zachary Brousseau


RAPS will host its annual Regulatory Convergence conference at the Gaylord National Resort and Convention Center at National Harbor on the DC waterfront 9–12 September. This year’s event features more than 75 educational sessions and over 200 speakers, including an opening keynote from FDA Commissioner Scott Gottlieb, MD. The Convergence is expected to draw more than 2,000 participants. It is the largest annual gathering of the global healthcare regulatory profession.

“This is the premier event dedicated completely to the regulatory profession,” said RAPS Executive Director Paul Brooks. “This is where top regulatory officials, senior executives, innovators and thought leaders come together to share knowledge, get updates, discuss trends and examine regulatory issues in depth from multiple angles.”

Highly anticipated topics on the agenda this year include Europe’s new medical device and in vitro diagnostics regulations, the impact of FDA user fee reauthorizations and the 21st Century Cures Act, medical device cybersecurity, developments in off-label promotion, regulatory challenges of conducting clinical trials in gene therapy, accelerating approval for medicinal products and more.

Regulatory agencies from around the world will be represented among session speakers and panelists. Agencies participating include: the US Food and Drug Administration (FDA); the European Medicines Agency (EMA); the World Health Organization (WHO); the Pan American Health Organization (PAHO); the Health Surveillance Agency, Brazil (ANVISA); the Pharmaceuticals and Medical Devices Agency, Japan (PMDA); the Medicines and Healthcare products Regulatory Agency, UK (MHRA); the National Regulatory Authority, Cuba and others.

For the full conference schedule, visit http://www.raps.org/convergence/#agenda Follow conference updates and conversations on Twitter using the #2017RAPS hashtag. Today, 10 August, is the final day for early discounted registration but attendees may register any time, including on site.

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