In a few weeks, 2012 RAPS: The Regulatory Convergence will bring approximately 70 healthcare regulators and some 2,000 total attendees from around the world to Seattle. 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.
This 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 a long list of expert speakers from agencies including the US 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.
Throughout the conference, 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 participating panelists from FDA, industry groups and other experts. Session presenters would like to hear from RAPS members and the regulatory community in advance what questions they have about the FDA user fee programs and their implementation. Questions can be submitted to RAPS online.
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.
Opening keynote speaker, Morton Hansen, co-author of Great by Choice and author of Collaboration, will discuss how regulatory professionals can work together to achieve great results.
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.
For more information and a complete listing of all conference sessions and events, visit RAPS.org/2012. Follow conference updates or share your thoughts on Twitter using the hashtag #2012RAPS, and for some ideas about what to do while in Seattle, visit RAPS' Experience Seattle blog.