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2013 Regulatory Affairs Professionals Society: The Regulatory Convergence in Boston to Feature Harvard Health School Dean, Biomedical Innovators, FDA and Global Regulatory Officials



9/24/2013 10:04:19 AM

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Rockville, MD, USA—Healthcare regulators, innovators, researchers, executives from pharmaceutical, biotechnology and medical device companies, and other regulatory professionals and stakeholders from around the world will gather at the Hynes Convention Center in Boston, 28 September–2 October, for 2013 RAPS: The Regulatory Convergence. The signature annual event of the Regulatory Affairs Professionals Society (RAPS), the Regulatory Convergence conference is largest annual gathering in world for the healthcare product regulatory profession.

The conference is expected to draw around 2,000 participants to hear about the latest developments in healthcare products, technology and regulation, and examine how regulations and regulatory systems are adapting to keep pace. Among the regulators scheduled to speak are 27 officials from the US Food and Drug Administration (FDA), including Jeffrey E. Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health (CDRH) and Jay Crowley, senior advisor, patient safety, CDRH; Howard Sklamberg, director, Office of Compliance, Center for Drug Evaluation and Research; and Daniel Fabricant, PhD, director, Division of Dietary Supplement Programs, Office of Nutrition, Labeling and Dietary Supplements, CFSAN. In addition, representatives from agencies in Europe, China, Japan, Taiwan, India, Brazil, Canada, Indonesia and Malaysia will also speak.

“This is a very dynamic and exciting time in the pharmaceutical, medical technology and biotechnology industries, and for the regulatory professionals who help bring these innovative technologies to market as products,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “2013 RAPS: The Regulatory Convergence will bring healthcare product regulators, researchers, scientists, industry representatives and other stakeholders from all over the world together in Boston to share the ideas, knowledge, best practices and new thinking that drives regulatory excellence and ultimately results in better healthcare products for patients.”

The full 2013 RAPS sessions schedule is available online and as an easy-reference session matrix PDF document. The Twitter hashtag for the conference is #2013RAPS.

The conference will open on Monday, 30 September with a keynote presentation on regulatory innovation and global health from Julio Frenk, MD, PhD, MPH, dean of the Harvard School of Public Health and the former minister of health of Mexico from 2000 to 2006.

Technologies such as 3-D bio printing and mobile medical apps are challenging regulators to adapt existing regulatory frameworks to products that were barely imaginable only a few years ago. In the conference’s closing plenary on Wednesday, 2 October, entitled “Medical Innovation: The Future is Closer Than You Think,” Laura Bosworth-Bucher of TeVido BioDevices, and Roger Narayan, PhD, MD, professor, Joint Department of Biomedical Engineering, University of North Carolina-North Carolina State University, will examine some of the latest medical innovations share their thoughts about how regulatory paradigms will need to shift in response.

In between the opening and closing, more than 75 individual sessions will cover all areas of healthcare product regulation, from R&D and clinical trials to marketing compliance and postmarketing surveillance. Some of the sessions expected to be of keen interest include the following:

Monday, 30 September

- FDA/CDER/Office of Compliance Feedback Session, 11:00 am–12:30 pm

- How to Establish Credibility with Health Authorities (The Do’s and Don’ts of Interactions with Regulatory Authorities), 11:00 am–12:30 pm

- Regulatory Landscape for Biosimilars Development: Part 1, 1:30–3:00 pm

- Practical Aspects of Implementing a Compliant UDI Program for Medical Devices, 1:30–3:00 pm

- Practical Considerations for the China Medical Device Market, 3:30–5:00 pm

- Regulatory Landscape for Biosimilars Development: Part 2, 3:30–5:00 pm

Tuesday, 1 October

- Promoting Device Quality in a Global Marketplace, 8:30–10:00 am

- Medical Device Innovation Consortium, 11:00 am–12:30 pm

- Challenges and Strategies in the Early Phase Development of Biological Products by Small Companies, 11:00 am–12:30 pm

- Personalized Medicine and Regulations, 11:00 am–12:30 pm

- FDASIA Tools: Accelerated Approval and Breakthrough Therapies, 1:30–3:00 pm

- Global FDA Compliance Update, 1:30–3:00 pm

- Regulatory Considerations in the Development of Biosimilars, 1:30–3:00 pm

- Regulatory Requirements for Cell Therapy Tools, 3:30–5:00 pm

For those seeking more in-depth instruction on specific subjects, one- and two-day workshops on 28 and 29 September will cover essentials of regulatory affairs for the US and the EU; regulatory strategy for medical devices; and for pharmaceuticals; Japan regulatory essentials for devices and IVDs; and medical devices in Latin America; as well as a regulatory managers’ boot camp.

Members of the working media who wish to cover all or part of 2013 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.

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 offices in Europe and Asia, and chapters and affiliates worldwide. RAPS.org

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