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The "2023 APEC Good Registration Management (GRM), Center of Excellence (CoE) Workshop" will be held.
Center of Excellence (CoE) Workshop
First local event after the COVID-19 pandemic
The Asia-Pacific Economic Cooperation Regulatory Harmonization Steering Committee (APEC RHSC) was established to promote regional regulatory harmonization for pharmaceuticals and medical devices as part of the APEC economic cooperation framework. Under the co-chairmanship of Japan and the United States, the RHSC is working to harmonize regulations on access to healthcare and medical products. Among its activities is the promotion of Good Registration Management (GRM), and the Pharmaceutical Manufacturers Association of Japan (PMAJ) has participated in the Asia Partnership Conference of Pharmaceutical Associations, Regulations and Approvals (APAC RAAC) and the APAC RAAC Expert Working Group (APAC RAAC). The Pharmaceutical Association of Japan (PAK), through the activities of the Asia Partnership Conference of Pharmaceutical Associations, Regulations and Approvals Expert Working Group (APAC RA-EWG), has selected experts from member companies since 2016 to develop training materials, dispatch lecturers, and cooperate in holding GRM CoE Workshops to train trainers of GRM. The Workshop has continued in a web-based format since the COVID-19 pandemic, but in 2023 it will be held locally in Taipei, Taiwan, for the first time in many years, and active discussions were held over three days from September 6 to 8.
Group photo of all lecturers
Introduction
GRM activities are continuously conducted based on the annual plan, which has been introduced in the Pharmaceutical Manufacturers Association Newsletter No. 177, 183, 187, 188, 194. 2023 Workshop in Taipei was held from September 6 to 8, 2023 with participants (8 economies, 83 people) gathered at Beitou Participants (83 people from 8 economies) gathered in Beitou Resort, Taipei, for a three-day workshop from September 6 to 8. I participated in the series of activities of the APAC RA-EWG as a lecturer, and I would like to report on my impressions of the event.
Scenery around the venue
Day 1
Mr. Shou-Mei Wu, Director General of the Food and Drug Administration (TFDA), Ministry of Health and Welfare, Taiwan, and the Asia Training Center for Pharmaceuticals and Medical Devices (ATCMDA) of the Pharmaceuticals and Medical Devices Agency (PMDA) The GRM Workshop was kicked off with words of expectation and encouragement for the participants from Ms. Ayumi Endo, Director of the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affair (ATC), and Mr. Shinji Hatakeyama of Eisai, the leader of the RA-EWG.
Mr. Shou-Mei Wu, Secretary of TFDA
RA-EWG Leader Mr. Shinji Hatakeyama
Mr. Ayumi Endo, Director of ATC Business Office, PMDA
As a Keynote Speech, Dr. Herng-Der Chern of TFDA gave a presentation on "Good Review Practice and Regulatory Convergence in Accepting Global Clinical Data for Regulatory Approval". Mr. Herng-Der Chern of TFDA gave a presentation on "Good Review Practice and Regulatory Convergence in Accepting Global Clinical Data for Regulatory Approval" as a Keynote Speech. After that, Mr. Aaron Sosa Mejia of EMA gave a presentation titled "Assessment of Global Clinical Data for Drug Approval in Europe," explaining the central review process in the EU, as well as the Accelerating In addition to the explanation of the EU central review, he also introduced recent initiatives such as Accelerating Clinical Trials in the EU (ACT EU), which was introduced in 2022, and The Clinical Trials Information System (CTIS), a portal site for storing a single unified document. In addition, the main theme of "Managing and Conducting the Review" was presented by Ms. Yueh-Tung Tsai of TFDA, Ms. Kanae Ohara of PMDA, Mr. Cheong Ooi Jin of the National Pharmaceuticals Regulatory Agency (NPRA) of Malaysia, and Mr. Vringga Sandia Surya of the FDA of Indonesia. The lecture was very interesting as it included the review systems and review methods of each country as well as expectations for GRM training.
Mr. Lawrence Liberti from University of Southern California (USC) presented the draft version of the Global Competency Framework for regulators of medical products of the World Health Organization (WHO). He also explained the importance of the Competency Framework.
The GRM Trainer's Manual was also introduced by the Pharmaceutical Manufacturers Association of Japan (PMAJ). Regulatory Licensing Team responded, and Ms. Hiroko Kawaguchi of MSD explained it to the participants.
Lawrence Liberti of USC
Day 2
Unlike the lecture session on Day 1, Day 2 consisted of three interactive sessions with lectures followed by group discussions. Note that this Workshop provided a valuable opportunity for companies (applicant side) and authorities (reviewing side), who are in different positions, to exchange opinions in the same group.
The first session, moderated by Mr. Rosa Fu of Eli Lilly Taiwan, focused on the Planning of Application, an important topic for companies. After discussing new drug and generic application strategies in eight groups, each team presented the application plans they had discussed in their presentations.
The second session continued the theme of the corporate side, Preparation of Application Dossier, and was led by the Pharmaceutical Cooperative Regulatory Licensing Team, which leads the APAC RA-EWG activities. The first half of the lecture session was moderated by Ms. Yukiko Noguchi of Astellas Pharma Inc. and a game called "Quick Memory Test" was played at the beginning of the session to ease the participants' tension. The game started with each participant memorizing a few items shown on a slide, and the final problem was to memorize dozens of items through teamwork. The game promoted communication within each group, which led to a very relaxed atmosphere for the lecture session.
Ms. Yukiko Noguchi of Astellas Pharma Inc.
In the lecture, Ms. Kumiko Ritta of Mitsubishi Tanabe Pharma Corporation introduced standard procedures for efficient preparation of high-quality application documents, followed by an explanation of various useful tools indispensable for application document preparation by Mr. Masaaki Kanno of Otsuka Pharmaceutical Co.
Ms. Kumiko Ritta of Mitsubishi Tanabe Pharma Corporation
Mr. Masaaki Jianno of Otsuka Pharmaceutical
The group discussion in this session continued in the afternoon after lunch, with Mr. Hatakeyama, RA-EWG Leader, moderating a discussion on the use of Digitization, Digitalization, and Digital Transformation (Digitxxx) from the perspective of application document preparation. A discussion was held on the use of Digitxxx, including future expectations. Various opinions were expressed, including dreams on the part of applicants, such as the hope that AI, the latest digital tool, will be able to take charge of checking the quality of application documents.
Group Discussion
The third session was the "Communications" session, moderated by Mr. Min Chen, advisor to TFDA (former FDA examiner in the U.S.), on the side of the authorities, and Mr. Wimolsiri Punjatanasak of MSD from APAC RA-EWG, on the side of the companies, explained the difficulties that applicants feel in communicating with the authorities. He explained the process, including the hurdles in communicating with the authorities that he feels are involved. As the session progressed, the relationships among group members became even closer across authorities and companies, and the discussions became more in-depth.
Day 3
In the morning, a discussion was planned on Critical Thinking and Regulatory Decision-Making, which is extremely important on the authorities' side. First, the importance of regulatory decision-making in the review process was explained, and a lecture was given based on trends, difficulties, and solutions in decision-making. In the group discussion that followed, discussions were held using hypothetical clinical data on pharmaceutical products. One of the discussion questions was, "Is there any clinical meaning to the PK/PD between Caucasian and Asian data?" The discussion was very practical and interesting, making us, the observers of the group discussion, think about it. The discussion was very practical and interesting, making us, the group participants, think about it. The cases were so different that we could experience the difficulty of decision-making and the problems faced by the examiners. This was the last group discussion in the workshop, and the discussion was heated, with even the teams having different opinions.
Scene of the session
Lunch
In the afternoon, the last Keynote Speech was given on the theme of "Decentralized Clinical Trials" by the U.S. FDA. After the closing session, Mr. Shou-Mei Wu, Director of TFDA, presented certificates of completion to the participants who had completed the workshop.
Mr. Shou-Mei Wu, Director General of TFDA, and participants in a commemorative photo
Conclusion
The APEC GRM Workshop adopted the Train the Trainer model, and before the COVID-19 pandemic, it gradually started to be effective, with several countries reporting that participants who attended the Workshop in Taiwan returned to their home countries to conduct local GRM Workshops as trainers. Some countries reported that the workshop participants in Taiwan returned to their own countries and held local GRM Workshops as trainers. However, due to the COVID-19 pandemic, there seems to be no progress in holding GRM Workshops other than the one in Taiwan. We hope that the holding of the GRM Workshop locally in Taiwan this time will serve as a stimulus for the GRM Workshop to be held again in other countries.
APAC RA-EWG members
( Hiroko Kawaguchi, APAC RA-EWG, Regulatory Licensing Team)