Attendees of RAPS’ 2018 Regulatory Convergence in Vancouver, 1–4 October, were among the first to learn about important developments and the latest news on topics including the coming EU Medical Device Regulation (MDR), the US Food and Drug Administration’s (FDA) cybersecurity policies and the results of RAPS’ comprehensive global salary survey of regulatory professionals. The event also marked the first time RAPS’ annual gathering has been held in Canada.
The conference featured more than 200 expert speakers, participating in more than 100 sessions covering all facets of the regulation of pharmaceuticals, biologics, medical devices and other health and medical technologies. Attendees heard from speakers and panelists from pharma and medtech companies and industry groups, academics, government agencies and other thought leaders. In all, around 2,000 people participated, including representatives from 125 exhibitors.
Global Regulators at the Convergence
Among the government bodies represented were FDA; Health Canada; the European Commission; the UK’s Medicines and Healthcare products Regulatory Agency; the Brazilian regulator, ANVISA; the Austrian Medicines Agency; the Austrian Federal Agency for Safety in Health Care; Japan’s Ministry of Health, Labour and Welfare, and also its Pharmaceuticals and Medical Devices Agency; the Ministry of Food and Drug Safety of Korea; the Ministry of Public Health of Cuba; COFEPRIS, the Mexican regulatory agency; and the Caribbean Public Health Agency.
The Regulatory Community Gathering
In keeping with RAPS’ emphasis on the importance of the global regulatory community, instead of a traditional opening keynote speaker, this year’s Convergence kicked off with a special welcome for first-time attendees followed by the official opening, an interactive “community gathering.” Attendees were welcomed by RAPS Board President—and native Canadian—Don Boyer, and RAPS Executive Director Paul Brooks, along with facilitator, Sara Michel, an expert on “connexity,” the intersection of community and connecting. Brooks appeared via video due to a family health concern.
RAPS Announcements and Awards
The opening session also served as the venue for several important announcements. RAPS announced the relase of its 2018 Global Compensation & Scope of Practice Report, an analysis of survey responses from more than 2,300 regulatory professionals on their compensation, responsibilities, priorities, backgrounds and more.
RAPS also introduced two new Regulatory Affairs Certifications (RACs): the RAC (Drugs) and RAC (Devices). The credentials and their associated exams will focus specifically on regulation of pharmaceuticals and of medical devices, respectively. The winners of RAPS’ Founder’s Award and Community Leadership Award, and the latest group of regulatory professionals named as RAPS Fellows also were recognized with video presentations during the opening session.
EU Medical Device Regulation
Among the buzzworthy topics and newsworthy events at Convergence, were the results of two new surveys about medical device makers’ readiness for the MDR, which will go into effect beginning in 2020. A joint RAPS/KPMG survey revealed concerns about a lack of understanding of the new regulation. Another report, this one from Team-NB, focused on the expected shortage of notified bodies prepared for the MDR as well as the new IVD Regulation to be implemented by the EU in 2022.
Director of FDA’s Center for Drug Evaluation and Research (CDER) Janet Woodcock described to attendees via video how of the agency’s reorganization of its Office of New Drugs will help support the modernization of new drug reviews.
ANVISA to Eliminate Backlog
The general manager of Brazil’s ANVISA vowed the agency would eliminate its backlog of new and generic drug applications by January 2019.
Cuban Regulator Discusses Challenges
Cuba’s CECMED director spoke about the Cuban agency’s evolution and challenges during a Latin America Forum session, and also addressed the topic in an interview that took place during the Convergence.
News From CDRH
Officials from FDA’s Center for Devices and Radiological Health (CDRH) gave a number of newsworthy updates this year. Center officials discussed their work on updated cybersecurity policies, a proposed de novo regulation, expanding the case for quality pilot program, and the creation of a pediatric device safety network.
IMDRF UDI Update
Virtual presenter Salvatore Scalzo, the European Commission’s policy and legal officer, provided an overview of the IMDRF UDI Application Guide scheduled for completion at the beginning of 2019.
Click this link for all coverage of the 2018 Convergence from Regulatory Focus.
Networking and Knowledge-Sharing
Along with speakers and traditional education sessions, attendees also participated in the always popular “Conversations That Matter” and new, but well received “Solution Circles” that allowed new and experienced regulatory professionals alike to engage in less formal discussion and collaboration. The exhibit hall and social opportunities like receptions, dine-arounds and the closing celebration rounded out the 2018 Convergence experience, giving attendees a chance to not just connect, but also have some fun.
See more photos from this year's Convergence in RAPS' Facebook photo album.
The 2019 Regulatory Convergence will be held 21–24 September in Philadelphia.