Last year, RAPS and the National University of Singapore (NUS) launched a joint graduate certificate program in Medical Devices Regulatory Affairs (MDRA) for Singapore-based regulatory professionals. The program was developed in partnership with Singapore’s government as part of its effort to help cultivate the highly competent regulatory workforce needed to support the country’s growing medical technology industry.
The first year of the MDRA certificate program will soon draw to a close as the 31 students enrolled in its initial cohort—several regulatory agency officials among them—prepare for their final presentations in August. The program currently is enrolling its next group of students, who will begin classes in September. Applications will be accepted until the 16 July deadline.
Foundational and Practical Knowledge
The program takes a blended learning approach, using a combination of online lessons, interactive classroom sessions and group projects. NUS faculty and experienced regulatory experts serve as instructors. It designed to give students foundational knowledge on the regulatory systems of ASEAN and other Asia-Pacific countries, China, the US and Europe, as well as practical tips and information from experienced professionals in the field.
As regulatory consultant and program instructor Michael Flood told Regulatory Focus last year, “[b]eing a competent regulatory affairs professional is not just about knowing the rules, but so much more. It is about understanding the role of regulation in ensuring safe products, it is about understanding the principles behind the rules and being able to apply them, and it is about interacting in a professional manner both within your own organization and on behalf of your organization.”
Denise Teoh, senior manager, diagnostics development hub, Exploit Technologies Pte. Ltd., one of the first group of students, calls the program “an ideal platform for entry- to mid-level professionals seeking to build a strong foundation in regulatory science, enhance existing regulatory know-how and integrate regulatory strategy into real-world, on-the-job settings.”
Teoh also praised the experience of going through the program for giving her an opportunity to build her regulatory professional network that she will rely on to help her stay current on important regulatory developments.
Cultivating Singapore’s Regulatory Workforce
For the Singapore government’s goal to develop its regulatory workforce, the program appears to be on target. “The MDRA program is an outstanding and comprehensive course, which [will] play a pivotal role in developing regulatory talent in Southeast Asia,” says David Lai, director of surgical research and development, department of surgery, National University of Singapore.
Over the past decade plus, the Singapore government has worked hard to attract biopharma and medical technology companies and the effort has worked, turning the country into a major hub for life sciences. By continuing to invest in infrastructure and promote the development of critical underlying needs like its regulatory workforce, Singapore has shown it remains committed to fully supporting the industry it has attracted.
For more information about the certificate program, visit NUS’s MDRA program page.
MDRA Faculty Discuss Importance of Regulatory Knowledge, Goals of Program