14 March 2013 | News | By BioSpectrum Bureau
The partnership aims to implement a new medical device regulatory affairs training program by the end of 2013
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."