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2011 Regulatory Affairs Professionals Society: The Regulatory Convergence to Bring Top Global Regulators to Indianapolis


9/29/2011 2:35:16 PM

Rockville, MD USA—Healthcare product regulatory professionals, who help ensure the safety, effectiveness and availability of pharmaceuticals, medical devices, biologics and other vital products, will gather at the Indiana Convention Center in Indianapolis, 22–26 October, for 2011 RAPS: The Regulatory Convergence. The convergence is the premier annual event from the Regulatory Affairs Professionals Society (RAPS).

The meeting traditionally known as RAPS’ Annual Conference & Exhibition has taken the title of The Regulatory Convergence to reflect its status as the largest annual gathering exclusively for the regulatory profession and a critical opportunity for regulatory professionals and thought leaders from industry, regulatory agencies, academia and other stakeholder organizations to come together to learn, network and exchange ideas.

“This conference is the key event of the year for the regulatory profession,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “No other gathering focuses on regulatory issues, developments and thought leadership in the global healthcare product sector like The Regulatory Convergence. In addition, with attendees and regulators from so many parts of the international regulatory community, the conference has become more globally focused and universally relevant than ever.”

2011 RAPS attendees will hear from top officials from the US Food and Drug Administration (FDA); the Council of Better Business Bureaus; the European Medicines Agency (EMA); the European Commission; China’s State Food and Drug Administration (SFDA); Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Ministry of Health, Labour and Welfare (MHLW); the Korea Food and Drug Administration; and Health Canada, as well as regulators from Australia, Mexico, India, The Netherlands, Saudi Arabia, Singapore and Taiwan.

Expert presenters will cover regulatory implications across a range of topics, including the latest developments in biotechnology, the regulatory pathway for biosimilars, regulation of software and mobile applications as medical devices, clinical evidence for combination products, drug delivery systems for biologic therapeutics, social media communications for medical products, 510(k) reform, global postmarket surveillance, regulatory considerations in the development of oncology drugs, business impacts of regulatory milestones and the role of regulatory at companies ranging from small start-ups to large multinationals.

Sessions such as the FDA reviewer panel, Japan’s PMDA/MHLW briefing, the EMA update and one covering the EU medical device recast are expected to draw keen interest.

Conference sessions are organized by subject-matter tracks in biologics/biotechnology, clinical, compliance, electronic intervention, health-related foods, medical devices and in vitro diagnostics, pharmaceuticals and regulatory business. Workshops will offer additional instruction on essentials of regulatory affairs for both the US and the EU, regulatory strategy, combination products, over-the-counter drugs and generics, as well as a regulatory managers’ boot camp.

More information and a complete listing of the more than 60 conference sessions and events are available at http://www.RAPS.org/2011. The Twitter hashtag is #2011RAPS.

This year’s conference will also present valuable “outsider” perspectives. In an opening keynote address, Dan Heath co-author with his brother, Chip, of The New York Times bestseller Switch: How to Change Things When Change Is Hard, will address why some big changes happen easily while many small changes prove impossible.

In a session on speeding access to therapeutic goods, Chris Hempel will share her unique insight on the drug review process. Hempel gained national attention as the mother of twin daughters diagnosed with a fatal genetic disease who succeeded in having an Investigational New Drug Application approved, despite having no previous medical background.

2011 RAPS will close will a special plenary session. Panelists will include representatives from the Cystic Fibrosis Foundation and Vertex Pharmaceuticals, along with other regulatory experts discussing the unique collaboration between the two organizations and its broader implications. The discussion will probe the role of the regulatory profession in addressing global health challenges, including the move toward more personalized approaches to medicine and increasing involvement of patient groups in developing new therapies.

Members of the working media who wish to cover all or part of 2011 RAPS should contact Zachary Brousseau, senior manager, communications for RAPS at zbrousseau@raps.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: 3D Communications, Abbott, Anson Group, Baker & Daniels, Biologics Consulting Group, BSI Healthcare, Eli Lilly, GE Healthcare, Medtronic, Parexel, Regxia, SGS, Stericycle ExpertRecall, Tarius, and TUV SUD. Media Partners are: Elsevier, Fierce Pharma, Indiana Medical Device Manufacturers Council, PharmaVOICE and Securing Pharma.

About RAPS

The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org


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