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2018 APEC Good Registration Management Regulatory Science Center of Excellence Workshop

【Update Date:2018-09-25】 unit:藥品組

  Taiwan Food and Drug Administration (TFDA) will host 2018 APEC Good Registration Management Regulatory Science Center of Excellence Workshop at the venue of Taipei Nangang Exhibition Center from September 26th to 28th. This is a training event under the auspices of APEC Life Science Innovation Forum (LSIF) Regulatory Harmonization Steering Committee (RHSC). This year's 3-day program follows the core curriculum of previous years and will train more than 60 trainees from Chile, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Papua New Guinea, Peru, Philippines, Singapore, Taiwan, Thailand and Vietnam, a total of 14 APEC member economies. The objective is to train more trainers for disseminating the concept of good registration management (GRM) in individual APEC member economies.

  More than 30 international experts were invited to deliver training in good review practices or good submission practices, including experts from German regulatory authority BfArM, Japan regulatory authority PMDA, UK regulatory authority MHRA, and several other institutions. The total number of participants is expected to be more than 120, including participants from 15 APEC member economies and 2 European Union member countries. This workshop is hosted by TFDA and co-organized by Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter, APEC LSIF-RHSC, Pharmaceutical and Medical Device Agency (PMDA) and Asia Partnership Conference of Pharmaceutical Associations (APAC).

  APEC is a premier economic forum in the Asia-Pacific region. TFDA has long been participating in the APEC LSIF-RHSC to promote (GRM). In July 2017, TFDA and RAPS Taiwan Chapter formally became an APEC Regulatory Science Training Center of Excellence in the area of GRM. Since then, the CoE has delivered an annual training event with focus on the best practices of good review and good submission. Established by APEC Leaders in 2002, the LSIF has since grown to become APEC's leading initiative on health and health sciences innovation. The LSIF Leadership recognizes Taiwan’s important contributions to the LSIF workstreams over the years and nominates Minister Shih-Chung Chen of the Ministry of Health and Welfare to succeed the chair of the LSIF Executive Board this year in August. Hosting this event has deepened and consolidated Taiwan’s international relations through capacity building, exchanges and cooperation, and added another highlight in Taiwan’s pharmaceuticals affairs after becoming an official member of ICH this year.