RAPS' Regulatory Convergence in San Jose to Focus on Healthcare Regulation and Innovation

ROCKVILLE, Md., Sept. 1, 2016 -- The Regulatory Affairs Professionals Society (RAPS) will bring the largest annual gathering of the global healthcare regulatory profession to San Jose, CA, 17–20 September. The 2016 Regulatory Convergence will take place at the San Jose McEnery Convention Center.

The Convergence is expected to draw more than 2,000 participants, including healthcare product regulators, scientists, researchers and regulatory professionals from life sciences companies. This year marks RAPS' 40th anniversary, and the Convergence will celebrate RAPS' four decades, as well as examine the future of the profession, healthcare product innovation and regulation. The focus on innovation is particularly apt this year as the event convenes in the heart of technology hub, Silicon Valley.

Attendees will hear an opening keynote on disruptive technology, new business models and how regulatory can keep up from leading tech analyst and author R "Ray" Wang. There also will be an innovation and technology panel discussion featuring top regulatory professionals from companies including 23andMe, and the associate director for digital health for the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health. The closing keynote speaker, Lori Hartwell, founder of the Renal Support Network, will provide a view from the patient perspective.

The conference will feature more than 100 educational sessions and 250 speakers on all aspects of healthcare products and their regulation. Major topics include biopharmaceuticals, medical devices, health-related foods, and legal and regulatory business issues. Some of the sessions on particularly hot topics will cover biosimilars, expedited approval pathways, personalized medicine and next generation sequencing, Zika clinical trials, real-world evidence, off-label promotion and more.

Regulatory agencies from around the world will be represented as session speakers and panelists, including for the first time ever, the head of Cuba's National Regulatory Agency. Other participating agencies include: FDA, the European Medicines Agency (EMA), the Pan American Health Organization (PAHO), the Brazilian Health Surveillance Agency (ANVISA), Pharmaceuticals and Medical Devices Agency, Japan (PMDA) and others.

For the full conference schedule, visit www.raps.org/convergence2016/Agenda or http://online.flipbuilder.com/verz/fuae to preview the program as a digital flipbook. Follow conference updates and conversations on Twitter using the #2016RAPS hashtag.

Reporters, bloggers and other members of the media who wish to cover all or part of RAPS' Regulatory Convergence should contact Zachary Brousseau, senior manager, communications for RAPS at [email protected] 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.

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 Shanghai and Singapore, and chapters and affiliates worldwide. www.RAPS.org

CONTACT: Zachary Brousseau
         Senior Manager, Communications, RAPS
         +1 301 770 2920, ext. 245
         [email protected]