Rockville, MD, USA—The Regulatory Affairs Professionals Society (RAPS) will bring approximately 70 healthcare regulators from around the world to Seattle next month as speakers for its annual conference, dubbed 2012 RAPS: The Regulatory Convergence, which is expected to draw around 2,000 attendees. The regulatory officials scheduled to speak represent national and international agencies overseeing health products, including 36 speakers from the US Food and Drug Administration (FDA), as well as representatives from agencies in Europe, China, Japan, India, Brazil, Canada and more. The Regulatory Convergence will take place at the Washington State Convention Center, 26–30 October.
The event is the largest annual gathering for regulatory professionals from around the world working for pharmaceutical, biotechnology, medical device and other related companies; regulators; researchers; academics and others involved in the regulation of healthcare and related products.
“We are excited to have so many regulatory agency representatives from around the world coming to Seattle for 2012 RAPS: The Regulatory Convergence,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “It is very gratifying to see how truly international RAPS’ annual conference has become. It is a unique opportunity to bring the global regulatory community together to examine the most important issues in the regulation of drugs, biotechnology, medical devices and other important products that impact so many lives every day.”
In addition to FDA officials, the conference also will feature speakers from the Federal Trade Commission, the Austrian Medicines and Medical Devices Agency, Peru’s DIGEMID, the European Medicines Agency, The European Commission, Japan’s Pharmaceuticals and Medical Devices Agency, China’s National Institute of Nutrition and State Foods, the Food Safety and Standards Authority of India, Health Canada, the UK’s Medicines and Healthcare Products Regulatory Agency, Brazil’s Nuclear Engineering Institute, and the Saudi Food and Drug Authority. For a full list of participating agencies and experts, visit http://www.raps.org/education-amp-training/2012-raps/experts.aspx.
Throughout the conference, expert speakers will update attendees on the latest developments in healthcare product regulation. Among the topics expected to draw particular interest are the FDA user fee programs established by the Food and Drug Administration Safety and Innovation Act (FDASIA) passed earlier this year. The user fees are mandated by FDASIA and are set to go into effect 1 October, but budget control measures have made the status of user fee programs themselves unclear. 2012 RAPS will feature a series of sessions examining FDA user fee programs with panelists from FDA, industry groups and other experts.
Other topics of interest will include the regulatory pathways for biosimilars among different global authorities; regulation of mobile apps, social media and software; global regulatory cooperation and harmonization; pharmaceutical advertising and promotion; new frontiers in vaccines; regulation of health-related foods; revisions to FDA’s 510(k) clearance process for medical devices; regulatory issues in clinical trials and clinical evaluation of medical devices; recalls and public access to safety information.
In a special plenary session on FDA’s Case for Quality initiative, Steven Silverman, director, Office of Compliance, Center for Devices and Radiological Health, FDA, and Howard Sklamberg, deputy associate commissioner, Office of Regulatory Affairs, FDA will outline the initiative, including goals, timelines and implementation.
In the conference’s closing plenary, Steve Usdin, host of BioCentury This Week, will lead a panel discussion exploring issues surrounding the impact of regulatory innovation on global health. The session will delve into issues such as how emerging markets will build regulatory capacity and how existing markets will increase their efficiency to provide consumers around the world with safe, affordable and effective products.
Conference sessions are organized by subject-matter tracks—biologics and biotechnology, clinical, compliance, electronic interaction, health-related foods, medical devices and in vitro diagnostics, pharmaceuticals, regulatory business and user fees.
For those seeking more in-depth instruction on specific subjects, one- and two-day workshops, taking place 26 and 27 October, will cover essentials of regulatory affairs for both the US and the EU; chemistry, manufacturing and controls; US combination products regulation; medical devices in Latin America; and strategic development of biosimilars; as well as a regulatory managers’ boot camp.
More information and a complete listing of all conference sessions and events are available at http://www.RAPS.org/2012. The Twitter hashtag for the conference is #2012RAPS.
Members of the working media who wish to cover all or part of 2012 RAPS should contact Zachary Brousseau, senior manager, communications for RAPS at firstname.lastname@example.org or +1 301 770 2920, ext. 245. On-site registration also will be available for media with valid press credentials or a letter from an assigning editor on company letterhead.
Conference sponsors include: Abbott, BSI, CCA, Cook Medical, GE Healthcare, OptumInsight, Pacific Bridge Medical, PDR Network, Research Presentation Strategies SGS, Tarius, Thoratec, and TUV SUD. Media Partners are: FierceMedicalDevices, PharmaVOICE and RegLink Associates.
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 offices in Europe and Asia, and chapters and affiliates worldwide. RAPS.org