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2017 APEC Good Registration Management Regulatory Science Center of Excellence Workshop

【Update Date:2017-10-30unit:藥品組

Taiwan Food and Drug Administration (TFDA) in collaboration with Japan in APEC Life Science Innovation Forum - Regulatory Harmonization Steering Committee (LSIF-RHSC) promotes Good Registration Management (GRM). A memorandum of understanding (MOU) was signed between TFDA and APEC LSIF in July 2017, and TFDA is an APEC Training Center of Excellence (CoE) in Regulatory Science in the area of Good Registration Management. TFDA will host “2017 APEC Good Registration Management Regulatory Science Center of Excellence Workshop” in National Taiwan University Hospital (NTUH) International Convention Center in Taipei from October 31 to November 2. APEC LSIF-RHSC, Pharmaceuticals and Medical Devices Agency (PMDA), Asia Partnership Conference of Pharmaceutical Associations (APAC), Regulatory Affairs Professionals Society (RAPS), Ching Kang Foundation for Pharmacy Promotion and National Yang Ming University are the primary co-organizers.

This workshop is a 3-day training program with Common sessions, Reviewer-Specific Sessions, and Applicant-Specific Sessions to offer the participants the concept of GRM through training regulators from different APEC member economies. It will be more than 90 participants from 13 different countries to attend this workshop; they are mainly from regulatory authorities and industry. There are more than 30 invited speakers from Japan, Canada, UK, Singapore, Philippine and Taiwan. In addition, there are more than 60 trainees from 10 different APEC economies including Hong Kong, Indonesia, Korea, Malaysia, Papua New Guinea, Philippine, Singapore, Thailand and Vietnam.

GRM working group will collect feedback from speakers and trainees through this Workshop to refine the GRM core curriculum and the training contents. TFDA has been participating in APEC LSIF-RHSC for years. By hosting this workshop, TFDA expects to enhance the quality and efficiency of the medical product registration process, shorten innovated product review time, and achieve the goal of promoting public health.