Regulators, pharmaceutical, biotechnology and medical device industry leaders, innovators, thought leaders and other regulatory stakeholders will participate in the Regulatory Affairs Professionals Society’s signature annual event.
Rockville, MD, USA—The practitioners of a profession that has a profound impact on healthcare around the world, but whose work is not well understood by the general public will gather in Austin, TX, this month when the Regulatory Affairs Professionals Society (RAPS) holds its annual Regulatory Convergence at the Austin Convention Center from 27 September through 1 October. 2014 RAPS: The Regulatory Convergence will bring together healthcare product regulators from agencies including US Food and Drug Administration (FDA), scientists, innovators, and representatives from small, mid-sized and large multinational pharmaceutical, biotechnology and medical device companies.
“Every day, consumers and patients around the world rely on healthcare products they count on to be safe and effective. It may not be well known or understood, but the regulatory profession—including regulators, industry professionals, researchers and others—plays a critical role in ensuring the safety and efficacy of those products,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “The Regulatory Convergence is where regulatory stakeholders from different areas and different parts of the world come to learn, network and share ideas. Beyond that, it’s where the regulatory community comes together to drive regulatory excellence at the individual, organizational and global levels.”
While the profession gathers in Austin, it presents an opportunity for healthcare journalists and bloggers to get insight into how medical products and technology are regulated, get the latest regulatory updates and hear directly from the people involved. The 2,000 expected attendees include those responsible for safeguarding public health and those who ensure the products their companies make meet regulatory standards, as well as industry vendors and exhibitors.
Program tracks include Biologics and Biotechnology, Health-Related Foods, Pharmaceuticals, Medical Devices and In Vitro Diagnostics, Regulatory Business and the roundtable-discussion Situation Room sessions. For the full schedule of workshops and sessions, visit http://connect.raps.org/2014raps/schedule, or download the conference program. Follow conference updates and conversations on Twitter using the #2014RAPS hashtag.
Topics to be covered in the more than 70 sessions by 250 speakers include:
- Regulatory challenges of bringing a mobile medical app to market
- Medical device cybersecurity
- Social media rules for the pharmaceutical and other closely regulated industries
- 3D printing and regulatory implications
- Regulation of human cells and tissues
- Clinical trials and transparency
- Healthcare regulation in emerging markets
- International regulatory collaboration and harmonization
See also: 10 Sessions We Can't Wait to Attend at 2014 RAPS
Speakers will include more than 50 officials from approximately 20 health authorities. Top officials from FDA who will be in Austin include: Ann Ferriter, director, division of risk management operations, Office of Compliance, Center For Devices And Radiological Health (CDRH); Sabine Haubenreisser, MSc, PhD, European Medicines Agency liaison official; Reynaldo (Ricky) R. Rodriguez, Jr., district director, Dallas District; Leah Christl, PhD, associate director for therapeutic biologics, OND Therapeutic Biologics and Biosimilars Team, Center for Drug Evaluation and Research (CDER); and Alberto Gutierrez, PhD, director, office of in vitro diagnostics, CDRH.
Several FDA officials will participate virtually, including CDER Director Janet Woodcock, MD; Kimberly Trautman, associate director, internal affairs, Office of the Center Director, CDRH; and Robert "Skip" Nelson, MD, PhD, deputy director and senior pediatric ethicist, Office of Pediatric Therapeutics.
Other international health authority speakers will include officials from the European Medicines Agency; the European Commission; the China Food and Drug Administration; Japan’s Pharmaceuticals and Medical Devices Agency, and Ministry of Health, Labour and Welfare; the Health Science Authority of Singapore; Health Canada; the Food Safety and Standards Authority of India; the Taiwan Food and Drug Administration; and the ministries of health of Malaysia, Indonesia, Singapore and Brazil.
Conference sessions will begin on Monday, 29 September with a keynote presentation on the continuing evolution in global healthcare and changing consumer behaviors and expectations from David Bosshart, PhD, CEO of the Switzerland-based Gottlieb Duttweiler Institute.
During the closing plenary on Wednesday, 1 October, expert panelists will tackle a similar topic from a different angle. Martha Brumfield, PhD, from the Critical Path Institute; Mike Ward, Health Canada; Murray Lumpkin, MD, MSc, Bill & Melinda Gates Foundation; and John Lim, Singapore Ministry of Health and the Duke-National University of Singapore Graduate Medical School will examine the complexity of delivering healthcare products to consumers around the world in a safe and cost-effective manner while dealing with shifting regulatory paradigms, regulatory science and regulatory capacity.
For those seeking more in-depth instruction on specific subjects, one- and two-day pre-conference workshops on 27 and 28 September will cover essentials of regulatory affairs and regulatory strategy for specific regions and product categories.
Reporters, bloggers and other members of the media who wish to cover all or part of 2014 RAPS should contact Zachary Brousseau, senior manager, communications for RAPS at email@example.com 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.