Rockville, MD, USA, Sept. 15, 2021 (GLOBE NEWSWIRE) -- The Regulatory Affairs Professionals Society (RAPS) today wrapped up its annual RAPS Convergence, the world’s largest conference dedicated to healthcare product regulation and regulatory issues. The event drew more than 1,500 participants again this year—from 37 countries around the globe—in the second year it was held virtually.
Convergence 2021 attendees heard from more than 300 expert speakers, including more than 50 from national and regional health authorities and notified bodies from around the world. More than 25 US Food and Drug Administration (FDA) officials were among the speakers.
The conference kicked off on Sunday, 12 September, with an opening plenary featuring FDA Commissioner (acting) 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).
In recorded remarks, Woodcock praised Convergence for creating “an important and valuable conversation with talented regulatory professionals, scientists and innovators with a direct connection to the development and regulatory processes.” Following that, Marks, Shuren and Nolte engaged in a discussion of the impact of the COVID-19 health emergency on the work of regulators. While acknowledging the extraordinary and unsustainable workload, panelists also commended their staffs’ dedication. “I think what's very motivating here is that we really are making a difference,” said Marks.
In another comment making news on Monday, during a CBER health authority forum, Marks defended FDA’s potential authorization of COVID-19 booster shots, in spite of two departing CBER officials questioning the need for boosters in a recently published opinion piece. Marks told session attendees that he is “fully confident” that evidence to be presented at an upcoming advisory committee meeting will provide “a good rationale for why boosters might be necessary.”
Over the course of four days, the event offered more than 200 sessions focused on in-depth education and networking opportunities, including speaker, author and chapter/local networking group meet and greets; interactive roundtables; and wellness and entertainment experiences. Plus, attendees had the opportunity to connect with 32 sponsor solutions providers via interactive virtual booths and matchmaking.
In a session this morning, RAPS and Elemed, a leading technical recruiter specializing in regulatory affairs, previewed the findings of a joint report on the Global Regulatory Affairs Professionals Workforce. The report found that nearly 100,000 professionals around the world currently work in the regulatory field. It examines data from LinkedIn, as well as an opinion survey of the global regulatory community, to provide a picture of the size and health of the global regulatory profession.
Other conference highlights included health authority forums with other top regulators from FDA’s CDER and CDRH, Health Canada, and Japan’s Pharmaceuticals and Medical Devices Agency and Ministry of Health, Labour and Welfare. Additional noteworthy sessions touched on topics such as advancing gene and cell therapies, the European Medicines Agency's study of using real-world evidence, the US-Japan 'Harmonization by Doing' program, and pediatric drug development pitfalls. Additional Convergence coverage is available on RAPS’ Regulatory Focus.
The conference garnered praise from attendees like Nancy Watts, a regulatory manager with Network Partners. Posting on social media, Watts wrote “This week's #RAPSConvergence has brought valuable insight from leaders in our field. Happy to be able to join and gain understanding of our current regulatory landscape, and know we really are all in this together.”
“I really must applaud the efforts of everyone who made this year’s Convergence such a success,” said Convergence Planning Committee Chair Meg Mucha, MJ, RAC, FRAPS, CQA, director, Q & R audit and compliance, Philips Healthcare. “The planning committee, the volunteers, the speakers, sponsors and RAPS staff all did an outstanding job delivering quality content and a virtual experience that truly benefited attendees.”
Convergence 2022 is planned for 11–13 September 2022 in-person in Phoenix.
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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