Regulatory Focus™ > News Articles > MDRA Faculty Discuss Importance of Regulatory Knowledge, Goals of Program

MDRA Faculty Discuss Importance of Regulatory Knowledge, Goals of Program

Posted 08 July 2014 | By Zachary Brousseau 

MDRA Faculty Discuss Importance of Regulatory Knowledge, Goals of Program

The Regulatory Affairs Professionals Society (RAPS) and the National University of Singapore (NUS) recently launched a joint Graduate Certificate in Medical Devices Regulatory Affairs (MDRA) program in Singapore. The program was developed in partnership with the government of Singapore to help cultivate an industry-ready regulatory workforce. The Singapore Workforce Development Agency recently announced it will provide funding for 70% of the registration fee to qualified Singapore citizens or Singapore permanent residents upon successful completion of the program.

The MDRA program draws on the teaching and research excellence of NUS’ biomedical engineering faculty and the real-world expertise of RAPS’ renowned regulatory leaders from around the globe, and it builds the foundational knowledge and important skills required of regulatory professionals.

Applying Regulatory Knowledge

“Being a competent regulatory affairs professional is not just about knowing the rules, but so much more,” said Michael Flood, principal, Locus Consulting, and one of the instructors for the program. “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.”

“As elsewhere, regulatory professionals in the Asia-Pacific region need well-developed skills in critical thinking, personal and professional ethics, communications, and cross-functional and cross-cultural collaboration,” said Michael Gropp, another of the instructors, and a professional with more than 30 years of engineering and regulatory affairs experience. “Developing these skills also can lead to competitive advantage—for the professional and the employer.”

A Global Curriculum

The MDRA curriculum will be delivered using a combination of online training, interactive seminars, peer interaction and case-based learning. “Through this blend of individual study, small group projects and tutorials, we expect this program to help students develop skills and prepare for leadership roles,” said Gropp. “In the introductory class, we will lay the foundation for themes that will run throughout the program.”

The curriculum covers regulations of Association of Southeast Asian Nations (ASEAN) countries, China, the Asia-Pacific region, the US and Europe. “This will allow students, whether they work for a Singapore-based exporter or a multinational corporation importing to Singapore and the region, to understand the context and requirements of other systems and to better plan, prepare and manage submissions,” explained Gropp. 

“Each section will build skills related to the major regulatory geographies around the world to enhance the understanding of differences, their rationale, and how to address global product development and management,” said MDRA faculty member Susan Alpert, former director of the US Food and Drug Administration’s Office of Device Evaluation, and former senior vice president and chief regulatory officer for Medtronic.

While the program examines the regulations of key regions and will give students a base of essential knowledge, Flood emphasized that it also positions students to better pursue their individual areas of interest. “The modular structure of this program, the course content, and the exercises and assignments are all designed not only to provide a broad understanding of the regulation of medical devices globally,” said Flood, “but also to encourage participants, through self-study, to develop their knowledge and competencies in the field.”

Enrollment in the program is open from now until 8 August. Visit www.bioeng.nus.edu.sg/edu/mdra.html for full program details and application information, or contact the RAPS Pan-Asia office at RAPSAsia@raps.org or Tel: +65 6496 5507.


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