Page 54 - 2018食藥署年報(英文版)
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a memorandum of understanding (MOU) in CoE operations in July 2017 based on the CoE
Operating Model stipulated by RHSC. This achievement is credited as a milestone for TFDA
because the capability in organizing regulatory science training has been well-recognized by
a regional harmonization initiative, and is attributed to our long-term involvement of APEC
activities.
Outcomes and Benefits
The TFDA hosted the “2017 APEC Good Registration Management Regulatory Science
Center of Excellence (CoE) Workshop” in Taipei between October 31 and November 2, 2017.
PMDA (Japan), RAPS Taiwan Chapter and Asia Partnership Conference of Pharmaceutical
Associations (APAC), Ching-Kang Foundation for Pharmacy Promotion (CKF) and National
Yang-Ming University were the co-organizers of this training event (Figure 3-4).
The training event lasted for 3 days, including common sessions, reviewer-specific sessions
and applicant-specific sessions. A total of 70 (industry, academy, and official) participants from
10 APEC member economies took part in this training event, including Hong Kong (China),
Figure3-4 Group photo of the “2017 APEC Good Registration Management (GRM) Regulatory
Science Center of Excellence Workshop”
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