Spearheading Regulatory Leadership In Asia

The Center of Regulatory Excellence at Duke-NUS will focus on pan-Asian regulatory policy for medical devices and pharmaceuticals.

AsianScientist (Nov. 7, 2014) – The Duke-NUS Graduate Medical School Singapore (Duke-NUS) has established a new Center of Regulatory Excellence (CoRE) to promote regulatory leadership, policy innovation in regulatory science and scientific excellence.

The biomedical and life sciences sectors have been rapidly developing across Asia, both in terms of clinical trials as well as biomedical research. While this presents opportunities, there continues to be a shortage of regulatory expertise, lack of supporting systems to facilitate regulatory policy innovation that addresses regional issues, and diverse regulatory requirements across different countries. These challenges may compromise the development of and timely access to quality therapeutic products for patients.

“The Center is the first dedicated pan-Asian Center for regulatory excellence targeted at the needs of both national health regulators and the biomedical industry, including pharmaceutical and medical device companies,” said Duke-NUS Dean, Professor Ranga Krishnan.

Leveraging on the Duke-NUS e-learning platforms and infrastructure, the center will develop programs with a focus on establishing competencies and building leadership capacity amongst senior staff and executives, across the biopharmaceuticals, medical devices and consumer healthcare industries. This is part of a multi-pronged strategy to promote regulatory excellence on a regional level.

To foster greater understanding of regulatory eco-systems and encourage policy innovation, the Center will also organize executive workshops and scientific seminars that stimulate the exchange of ideas and discussion on key issues across the regulatory landscape in Asia. These include current topics like the regulation of mobile health applications, adaptive licensing for expedited approvals, and personalized medicines.

CoRE is supported by Singapore’s Ministry of Health and Health Sciences Authority, and will be located within the Duke-NUS Graduate Medical School. Associate Professor John Lim, former CEO of HSA, has been appointed the Center’s Executive Director, concurrent with his role as MOH’s Deputy Director of Medical Services for Industry & Research Matters. An Advisory Board comprising key leaders with experience in regulatory agencies, industry and academia has been assembled to provide longer term strategic guidance for the Center.

“Regulation must follow science and where science proceeds apace, regulation may find it difficult to keep up. Thus, the creation of the Center of Regulatory Excellence in Singapore is both timely and opportune,” said Advisory Board Chairman, Professor Sir Alasdair Breckenridge.

Mr. Kevin Lai, Executive Director of Biomedical Sciences, Singapore Economic Development Board (EDB) said, “CoRE is a strategic platform where industry and regulators will be brought together to enhance regulatory knowhow and promote best practices in the region. With the increasing interest among global biomedical companies in Singapore as their regional headquarters in Asia, CoRE will help to build a pipeline of regulatory talent to support the growth of industry and Asia’s healthcare needs.”

The new Center will also link Duke-NUS initiatives in Singapore back to Duke University’s Translational Medicine Institute (DTMI) in USA—a center where the clinical and translational research community comes together.

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Source: Duke-NUS Graduate Medical School.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.

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