Registration commences on 25 April 2018 and closes on 15 July 2018.
Please select your modules for Graduate Certificate in Pharmaceutical Regulation in AY2018/2019, Semester 1, only if you have received a Letter of Offer.
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 Centre (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).