2016 APEC Good Registration Management Regulatory Science Center of Excellence Workshop

The 2016 APEC Good Registration Management (GRM) Regulatory Science Center of Excellence (CoE) Pilot Workshop was conducted in Taipei, during 15-17 November, 2016. The objectives of this pilot workshop were to disseminate the concept of GRM, to promote the best practices of GRM, so as to enhance the quality and efficiency of the medical product registration process and review time, thus to achieve the ultimate goal of promoting public health.

The 2016 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), The APEC Harmonization Center (AHC) and Regulatory Affairs Professionals Society Taiwan Chapter (RAPS Taiwan Chapter).

The pilot workshop is consisted of 3 major sessions, the common sessions, and the parallel separate session of applicant-specific sessions and reviewer-specific sessions. Series of topics like Basic Concept of GRM, An overview of Good Review, An Overview of Good Submission, Planning of application, Preparation of application dossier, Managing the review, Review personnel-critical thinking, Conducting the review, Communication: fundamentals and case studies, Rolling out the GRM training program in each economy were delivered by expert speakers in the 3-day-program. Moreover, the program brought together participants of regulatory agencies, academia and industries, to discuss about the best practices and regulatory science of GRM.

Overall, the workshop was well attended by more than 102 participants from 17 economies (Chile, China, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Papua New Guinea, Peru, Philippines, Singapore, Thailand, Taiwan, USA, UK and Vietnam). Among the participants, there were 56 trainees, 32 expert speakers, 3 facilitators and one observer.

Comments from participants:

For the Common Sessions:

“It would be better to be more interactive“

“More examples from other regulatory agencies, about communication between applicants and regulatory agencies“

“More case studies & examples“

For the Applicant-Specific Sessions:

“Free discussion, QC was very fun“

“Very interactive and practical“

“The case study that focus on communication is very good“

For the Reviewer-Specific Sessions:

“Ms. Houn's session was very good and interactive“

“This session is very interesting and useful“

“Well presented and appreciated. Recommendation on how best we can develop a framework to monitor the implementation of this important training course to different regulatory systems“

For the workshop:

“The workshop was a great experience, very enriching, that I try to take advantage of the movement and that intend to apply in my country has been learned“

“Excellent workshop“

“Excellent speakers and topics. I learn a lot. Thank you for the initiation“

Brief summary of feedback from trainees:

The pilot workshop was rated of high satisfaction from the participants. Most participants commented the pilot workshop was good with significant interactive elements, such as interactive discussions, group discussions, case studies and practices. The overall written feedbacks from trainees were further organized and considered. It was planned (1) to create more collaborative sessions to allow trainees from industry to talk to regulators, (2) to provide more case studies and interactive discussions, and (3) to put more emphasis on the topics of “communication” and “critical thinking” for the 2017 training program.