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.
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.
Following up on CoRE’s previous Seminar Series on regulatory developments in China, the China Food and Drug Administration (CFDA) 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.
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.
Expert pharmacovigilance trainers from the World Health Organisation (WHO), the Uppsala Monitoring Center (UMC), and the Health Sciences Authority (HSA) of Singapore, will share with participants their expertise and experience over a 3-day workshop, jointly organised with the WHO, UMC, HSA, and CoRE, as part of a continuation of efforts to enhance pharmacovigilance capabilities in the ASEAN region. Given this year’s underlying theme of “Partnerships to Protect Public Health”, we welcome participation from non-regulators, such as people from the industry and non-government organisations (NGOs).