Regulatory Convergence Preview: Regulation and Innovation

Posted 01 September 2016 By Zachary Brousseau


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 or to preview the program as a digital flipbook. Follow conference updates and conversations on Twitter using the #2016RAPS hashtag.

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