2018 APEC Good Registration Management Regulatory Science Center of Excellence Workshop

:::

Drugs

APEC in Taiwan

【Update Date：2019-03-13】unit：藥品組

On Sep 26-28, 2018, the Taiwan Food and Drug Administration, Ministry of Health and Welfare (TFDA) and Regulatory Affairs Professionals Society Taiwan Chapter (RAPS Taiwan Chapter) convened the 2018 APEC GRM CoE workshop for promoting regulatory convergence and understanding in the area of Good Registration Management. This workshop was participated by a total of 62 regulators and industry from 14 APEC member economies, including Chile, Hong Kong, Indonesia, Japan, Republic of Korea, Malaysia, Mexico, Papua New Guinea, Peru, Philippines, Singapore, Chinese Taipei, Thailand and Viet Nam.
The workshop opened with remarks by Dr. Shih-Chung Chen, Minister of Ministry of Health and Welfare, followed by the message from Dr. Shou-Mei Wu, Director General of TFDA, Ministry of Health and Welfare and Dr. Eriko Fukuda of PMDA and Dr. Shinji Hatakeyama of Eisai Co. Subsequent lectures and case studies were co-organized by TFDA/RAS Taiwan chapter/PMDA/APAC. The topics discussed included the introduction of GRM and experience sharing from different APEC member economies, managing and conducting the review, critical thinking and regulatory decision making, planning of application, preparation of application dossier/ practice, comprehensive exercises in GRM, competencies and training for reviewers and applicants and rolling out the GRM training program in each economy. The participants provided the details of the status of implementing GRM in their own economies and positively engaged in discussions throughout the seminar. (see agenda for details).
A total 28 trainers from TFDA/ PMDA/MHRA/APAC/RAPS Taiwan chapter/Duke-NUS CoE contributed to the lectures and case studies.
On the final day of the seminar, the Course completion certificates were handed to each participant by Dr. Shou-Mei Wu, director general of FDA.

Comments from participants:

For the Common Sessions:

〝Achieve cooperation ties with different APEC health agencies and strengthen the GRM initiative around the world〞

〝Know the different realities and problems that exist in all APEC countries〞

〝Collect useful information on how to start the implementation of Good Review Practice〞

〝Learn what added values can be obtained via Good Review Practice and Good Submission Practice〞

〝Affirm the concepts of Good Review Practice and Good Submission Practice〞

For the Case Study Session:

〝Effective and Efficiency communication〞

〝The case study derived clear strategic direction for submission〞

〝The case studies improved the management of the preparation process for application dossier〞

〝Through case study sharing, all participant well understood the standard process for a high-quality submission preparation〞

Brief summary of feedback from trainees:

From the on-site survey form which analyzed for assessing the performance of this train program, most sessions could be considered as good satisfactions. Both speakers lead a lively interaction with audiences and the participants initiated to discuss the topic of how to resolve identified common issues and challenges.The response ratio of the onsite evaluation during the 3 days of workshop was between 69%-88%. Basically, all sessions were highly evaluated. To have more clues to improve and revision of further GRM training activity held in the 2019.The written feedbacks from trainees were further organized and considered.

For more information, please refer to http://www.apecgrmcoe.tw/2018CoE/index.html

Photos