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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Austin is known for many things. It is the capital of Texas, home of the state’s flagship university, a celebrated music hub, host of the annual South-by-Southwest technology and culture festival, and a famously eccentric city that proudly embraces its “Keep Austin Weird” motto.
Next month, Austin also will play host to regulatory professionals from around the world attending 2014 RAPS: The Regulatory Convergence, RAPS’ signature annual event and the world’s largest annual gathering for the healthcare product regulatory profession. The conference will draw approximately 2,000 participants to the Austin Convention Center, 27 September–1 October, to learn about and discuss important developments in medicine and healthcare technology, and the myriad regulations that help ensure their safety and effectiveness for patients and consumers across the globe.
The Regulatory Convergence brings regulatory executives from pharmaceutical, biotechnology, medical device and other companies making health products that require regulatory oversight together with regulators, researchers and healthcare thought leaders. More than 50 regulatory agency officials will present updates and participate in sessions throughout the conference.
Among the participants will be officials from the US Food and Drug Administration (FDA); 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 Korea Food and Drug Administration; the Taiwan Food and Drug Administration; and the ministries of health of Malaysia, Indonesia, Singapore and Brazil.
“Regulatory systems around the world no longer exist in isolation. Healthcare is global so regulators and regulatory professionals must think and work globally too,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “The Regulatory Convergence gives them an opportunity every year not only to build knowledge and competencies, but also to come together in person to catch up on trends, share ideas, discuss what’s on the horizon and network with colleagues who understand their challenges.”
2014 RAPS will open with a keynote address from David Bosshart, PhD, CEO of the Gottlieb Duttweiler Institute in Rüschlikon, Switzerland, a think tank specializing in trend research, retail, economic and social issues. Bosshart will discuss the continuing evolution in global healthcare, changing consumer behaviors and expectations, technological advances and how these elements will drive changes in the regulatory sector. A new group of RAPS Fellows also will be honored at the opening plenary.
The conference’s education sessions will cover biologics and biotechnology, health-related foods, pharmaceuticals, medical devices and in vitro diagnostics, and regulatory business. Session speakers from industry, regulatory agencies and academia will go in depth into important developments in RAPS’ core areas: drugs, devices and biotechnology. In addition, the health-related foods track has been redesigned to take place all on a single day, Tuesday, 30 September, and will feature authoritative speakers from the Consumer Healthcare Products Association, the International Life Sciences Institute Focal Point in China, the HealthCare Nutrition Council, Health Canada, the European Commission and FDA’s Center for Food Safety and Applied Nutrition.
In between sessions, attendees will be able to network over refreshments, browse the exhibit hall featuring more than 100 exhibitors or stop by RAPS Central to talk with RAPS staff, ask questions, participate in the “RAPS Experience” interactive game, purchase books or products or just take a moment to relax. RAPS staff also will be available at the RAPS Membership Booth inside the exhibit hall. There, attendees can get a professional headshot and upload it right to their professional profiles on RAPS’ Regulatory Exchange online network, take pictures in front of the RAPS logo wall and more.
Those interested in learning more about Regulatory Affairs Certification (RAC) will be able to ask questions at one of two 45-mintue RAC mini sessions taking place Monday and Tuesday. RAC-credentialed professionals and members of the Regulatory Affairs Certification Board will be on hand to answer questions.
When the day’s sessions are done, attendees will have a chance to unwind and chat with colleagues at a reception with exhibitors Monday evening featuring gourmet fare from some of Austin’s finest food trucks and local Texas beers, as well as live music featuring the Brain Pounds Band. On Tuesday evening, there will be a hosted cocktail hour and an opportunity to attend one of the always popular “dine-arounds,” dinner with other attendees at some of Austin’s highly regarded local restaurants.
Registration for all or part of 2014 RAPS is open now. Attendees can get the discounted rate if they register by 29 August. Those who want additional exclusive training in particular regulatory subject areas may sign up for one RAPS’ eight pre-conference workshops, which will take place Saturday and Sunday.