RAPS – Singapore to Collaborate on First Medical Device Regulatory Training

The Regulatory Affairs Professionals Society (RAPS) is partnering with five Singapore government agencies to develop and implement a new medical device regulatory affairs (MDRA) training program by the end of 2013. In addition to covering the regulatory systems of the US, Europe and Asia Pacific markets, the training program will be the world’s first to offer instruction focused on the medical device regulatory requirements across Southeast Asian markets.

singaporeThe five agencies involved are the Agency for Science, Technology and Research, Health Sciences Authority, Singapore Economic Development Board (EDB), SPRING Singapore and the Singapore Workforce Development Agency.

For medical device companies seeking access to markets in Asia, skilled and knowledgeable regulatory talent is becoming increasingly critical to successfully navigate the fragmented regulatory environment.

Singapore has emerged as a leading biomedical hub in Asia today for global medical device companies to conduct their research and development, manufacturing and regional headquarters activities. Through its first-of-its-kind MDRA training program in Singapore, RAPS aims to help cultivate the next generation of medical device regulatory professionals for Asia.

“RAPS is a global leader in the training and development of regulatory professionals and we are highly supportive of their plans to develop the region’s first MDRA training program in Singapore. This program will build up regulatory capacity available in Singapore and the region, to facilitate the market adoption and innovation of new medical devices,” said Kevin Lai, director, biomedical sciences, EDB.

RAPS’ proposed training program will take a blended learning approach, combining elements of online learning with in-person lectures, interactive seminars and case-study-based learning by renowned regulatory experts from Asia, Europe and North America. This program will be jointly implemented by RAPS and a training partner in Singapore.

“With our extensive experience defining competencies of regulatory professionals, providing self-paced and in-person applied regulatory education, and our coverage of regulatory systems throughout the world, RAPS is well-positioned to work with the EDB and a local partner to create regulatory training specifically for Southeast Asia’s needs,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “This initiative aligns perfectly with RAPS’ goal of driving regulatory excellence and building global regulatory talent and capacity.”

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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About Christopher Ford

Christopher Ford is an expert in global medical device manufacturing compliance with over 20 years of experience, specializing in Class II and Class III medical devices and combination products. He is a certified ISO 13485 Lead Auditor, with over 600 audits under his belt, and he works with organizations of all sizes. His approach to compliance requirements balances customer needs with business objectives, while assuring that all regulatory requirements are met.