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Regulatory Affairs Professionals Society, Singapore to Collaborate on First Medical Device Regulatory Training Program in Southeast Asia


3/14/2013 10:58:48 AM

Singapore—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.

The 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.”

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 Europe and Asia, and chapters and affiliates worldwide. RAPS.org

About the Singapore Government Agencies

About A*STAR

The Agency for Science, Technology and Research (A*STAR) is Singapore's lead public sector agency that fosters world-class scientific research and talent to drive economic growth and transform Singapore into a vibrant knowledge-based and innovation driven economy.

To learn more, visit http://www.a-star.edu.sg.

About HSA

The Health Sciences Authority (HSA) applies medical, pharmaceutical and scientific expertise through its three professional groups, Health Products Regulation, Blood Services and Applied Sciences, to protect and advance national health and safety.

To learn more, visit http://www.hsa.gov.sg.

About EDB

The Singapore Economic Development Board (EDB) is the lead government agency for planning and executing strategies to enhance Singapore’s position as a global business centre.

To learn more, visit http://www.sedb.com.

About SPRING

SPRING Singapore is an agency under the Ministry of Trade and Industry responsible for helping Singapore enterprises grow and building trust in Singapore products and services.

To learn more, visit http://www.spring.gov.sg.

About WDA

The Singapore Workforce Development Agency (WDA) aims to help workers advance in their careers and lives by developing and strengthening skills-based training for adults.

To learn more, visit http://www.wda.gov.sg.



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