2019 APEC Good Registration Management Regulatory Science Center of Excellence Workshop

The 2019 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence (CoE) Workshop was conducted during 17-19 September, 2019 in Taipei.

The objectives of the workshop were to disseminate the impact of regulatory science training of GRM in APEC and further to adopt GRM’s application and best practices to the product life cycle.

The 2019 APEC GRM CoE Pilot Workshop was hosted by Taiwan Food and Drug Administration (TFDA) and were collaborated with the APEC Life Science Innovation forum (LSIF) Regulatory Harmonization Steering Committee (RHSC), Pharmaceuticals and Medical Devices Agency (PMDA), Asia Partnership Conference of Pharmaceutical Associations (APAC) and Regulatory Affairs Professionals Society Taiwan Chapter (RAPS Taiwan Chapter).

The 2019 workshop began with Dr. Shou-Mei Wu, Director General of Taiwan Food and Drug Administration (TFDA), Dr. Eriko Fukuda, Office Director of Pharmaceuticals and Medical Devices Agency (PMDA), Japan and Dr. Shinji Hatakeyama, leader of Regulations and Approvals Expert Working Group (RA-EWG) of Asia Partnership Conference of Pharmaceutical Associations (APAC), Japan. The followed fundamentals sessions and case studies were planned by TFDA/RAPS Taiwan Chapter/PMDA/APAC. The 3-day-program were arranged in the consideration of the life cycle of medical products, began with the sessions of Planning of Application and Preparation of Application (Pre-market consideration) in day 1, followed by the Sessions of Managing & Conducting the review, Critical Thinking and Regulatory Decision-Making (Reviewing after submission) in day 2, and finally the session of Application of the GRM Concept to Post Marketing Surveillance (Post-market surveillance). A total of 21 experts from domestic and foreign regulatory authorities and pharmaceutical industries, such as U.S.A, Denmark, Canada, Japan, Singapore and Taiwan, were invited to introduce how to apply GRM to the entire product life cycle.

The workshop were delivered to 67 trainees from 12 APEC member economies (Including Brunei Darussalam, Chile, Hong Kong, Indonesia, Korea, Malaysia, Papua New Guinea, Peru, Philippines, Chinese Taipei, Thailand, and Vietnam). However, the overall number of workshop participants was 173 (from 16 APEC member economies and 1 European Union member state).

Comments from participants:

For the Day 1 Sessions:

“Very good arrangement. Thanks! “

“Good Session, but the place can be bigger for focusing team. “

“More time to allocated for case discussion & presentation“

For the Day 2 Sessions:

“More time for each lecturer especially with those who have very new topics.”

“If possible, can arrange the schedule not to be too packed so that we have time to group all the info delivered/shared and also have time to think of questions that may be useful In the process of establishing GRM in our country.”

“The experts from EU, FDA, and Canada make it excellent.”

For the Day 3 Sessions:

“Clear introduction for EU NDA reviewing category and good examples of elaborating the RWE, very helpful for understanding how to utilize RWE better in the future, thanks.”

“May consider role-play session as wrap-up”

“More time for country sharing, particularly sharing best practice.”

For the workshop:

“Good program; high quality presentation reports; good logistics”

“Excellent training & organized”

“It would be interesting to survey the participants of the workshop from regulatory authorities about the amount of new drug applications and generic drug applications in their countries in the last year, and how many reviewers they have for both kinds of application. As a reviewer, this information would be very useful to put in context the challenges that my institution faces and how those challenges are faced by other regulatory authorities”.

Brief summary of feedback from trainees: