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Advanced Therapies is a rapidly advancing field that offers exciting new therapeutic possibilities. To promote a better understanding of the frameworks and processes regulating cell, tissue, and gene therapies, this 2.5-day workshop provides a platform for global and regional experts to share their expertise and experience, including major and regional regulatory authorities, as well as leading companies in this domain. This second pilot workshop has been co-developed with guidance from APEC Life Sciences Innovation Forum Regulatory Harmonization Steering Committee (RHSC) and a programme committee consisting of the Health Sciences Authority (HSA) Singapore, and key opinion leaders from industry and scientific organisations.
Following up on CoRE’s previous Seminar Series on regulatory developments in China, China's regulatory agency has since met all of its objectives to initiate reforms to its regulatory frameworks in 2017. This resulted in a reduction of lag time, increase in regulatory capacity and the implementation of a science-based regulatory review approach. To further improve China’s regulatory environment, the Deepening Reform was implemented in October 2017 which has resulted in the publication of various new guidelines, regulations and requirements. In light of these rapid and successive changes, this seminar examines the key reforms and their impact on the global regulatory environment in the near future.
Accessibility to accurate and reliable information is essential to healthcare professionals and patients for ensuring the safe and correct use of health products. A trend of providing electronic product information, or e-labelling, over the use of traditional printed labels is accelerating. This shift in improving accessibility to information opens up exciting possibilities for health literacy, but also raises concerns. The advent of the internet and social media has resulted in an explosion of alternative information sources, increasing the risk of accessing incorrect information, and potentially compromising the appropriate use of health products. CoRE welcomes you to join us for this seminar with Dr Shimon Yoshida on the potential for e-labelling in Asia and sharing initiatives from other parts of the world. Closing the seminar will be a panel discussion with representatives from the healthcare sector, regulatory authority and industry to further discuss the contemporary topic of e-labelling.
We are pleased to welcome you to the launch of the Duke-NUS Centre of Regulatory Excellence (CoRE) Graduate Certificate in Pharmaceutical Regulation. This is dedicated regulatory training programme caters to the learning needs of regulatory professionals in national regulatory authorities and industry, researchers, healthcare professionals and other stakeholders interested to gain a deeper understanding of regulatory science, both in terms of international best practice and specific relevance to South-East Asia and Asia-Pacific. To find out more, join us at the open house.
Singapore’s rapidly ageing population and growing burden of chronic diseases have created a new imperative for population health improvement. These challenges open new opportunities for policymakers and providers to source and scale payment and delivery innovations to fill key needs. For example, initiatives such as the new Health IT Master Plan (HITMAP) highlight how the path towards population health will depend on the capacity to collect, share, analyse, and act upon health and social data. This talk will provide a global perspective on policy, payment, and delivery innovations that hold promise to improve health and healthcare, and opportunities in Singapore to incorporate global lessons to transform the health system toward population health.
Data sources such as electronic health records and patient registries enable the development of real world evidence (RWE), which can inform decisions across the medical product lifecycle, including treatment decisions and those that impact care quality as well as payment and delivery. While the U.S. FDA has relied on RWE to support decision-making in specific contexts, there are further opportunities for RWE to further enhance the regulatory framework, especially regarding efficacy and benefit. CoRE invites you to join us for Professor Gregory Daniel’s seminar, which will: 1) provide an update on the current U.S. policy landscape with respect to RWE; 2) describe current efforts to support the enhanced development and use of RWE across a range of activities; and 3) stimulate discussion on how lessons from the U.S. context might inform existing efforts in Singapore.
APEC Life Science Innovation Forum Regulatory Harmonization Steering Committee Meeting. By Invitation only.
DIA and Duke-NUS Centre of Regulatory Excellence (CoRE) will host a 2-day conference in Singapore on accelerating access to health products to improve the response to pandemic diseases. Over these 2 days, we will discuss the global impact of infectious diseases and approaches to expedite research and product development (including vaccines and medical devices). We will also explore the pathways to accelerate patient access to innovative products and how to effectively manage a pandemic situation in Asia.
Of all the fields that Artificial Intelligence (AI) will disrupt in the coming years, the healthcare market may see the greatest paradigm shift. We will discuss current trends in AI development and investment in the healthcare sector, as well as the Food and Drugs Administration (FDA) regulatory hurdles that such technology may encounter.
As medical management moves beyond the traditional pills, tablets and injections, the arrival of new treatment modalities in the form of cells, tissues and gene therapies has gained the attention of many in the healthcare environment. While these products hold new promises and advances in medical sciences, they also pose new challenges and concerns across various stakeholders.