2/24 International Pharmaceutical Regulatory Science Symposium
The Platform for Research and Inspiration in Regulatory Science co-hosted the International Pharmaceutical Regulatory Affairs Symposium on February 24, 2023, which was organized by the Taiwan Society of Regulatory Affairs for Medical Products. Dr. Scott Grossman and Ms. Susan Chan, the foreign regulatory affairs directors of Merck Sharp & Dohme (MSD) company introduced the various measures adopted by the US FDA Oncology Center of Excellence (OCE) and their benefits to the industry, as well as to share practical experiences of MSD in the field. The panel discussion section was hosted by Prof. Churn-Shiouh Gau, the principal investigator of the Platform for Research and Inspiration in Regulatory Science and Prof. Jaw-Jou Kang, the Chairman of the Taiwan Society of Regulatory Affairs for Medical Products. Representatives from the non-industry council members of the Taiwan Society of Regulatory Affairs for Medical Products, the division of Medicinal Products, Taiwan Food and Drug Administration, and the Center for Drug Evaluation, Taiwan, as well as experts, scholars, and industry leaders were gathered together. The panelists discussed the progress of the US FDA's accelerated approval process and the opportunities for Taiwan to participate in Project Orbis Partners (POP), as well as exchanged observations and suggestions for further improvement on regulatory oversight for the domestic industry.
2/24 國際藥政法規專題演講「Introduction of US FDA Oncology Center of Excellence Initiatives and Project Orbis」
於2023年2月24日，國際藥政法規科學研究平台協辦，由台灣醫藥品法規學會主辦的「國際藥政法規專題演講」。Merck Sharp & Dohme（MSD）公司國外法規主管Dr. Scott Grossman和Ms. Susan Chan介紹美國FDA腫瘤卓越中心（Oncology Center of Excellence, OCE）所採取的各項措施及其對產業界的效益，並分享MSD的相關實務經驗。綜合討論由國際藥政法規科學研究平台主持人高純琇教授與台灣醫藥品法規學會理事長康照洲教授主持，邀請到多位專家學者、產業界先進以及相關機構代表參與，包括台灣醫藥品法規學會非業界理事、衛生福利部食品藥物管理署藥品組、財團法人醫藥品查驗中心等代表，針對美國加速審查流程的進展情況以及台灣參與Project Orbis Partners（POP）的合作機會，討論國內產業在法規管理方面的觀察和改善建議。
