Topics The 11th Annual Meeting of the Regulatory Science Society of Japan held
The 11th Annual Meeting of the Regulatory Science Society of Japan was held on September 17 and 18, 2021, under the theme of "Regulatory Science for Accelerating Social Implementation" at the web venue.
Introduction
The Society for Regulatory Science was established in August 2010 with the founding philosophy of bringing together people in the medical field, universities and research institutions, industry and regulatory authorities to openly discuss research results and ideas related to regulatory science of pharmaceuticals and medical devices, and to promote the academic progress and dissemination of such science. The Society will celebrate its 11th anniversary in 2021, during which time the concept of regulatory science has been widely spreading. The conference was held on September 17 and 18, 2009. The conference consisted of a plenary lecture, 3 special lectures, 13 symposia, and 32 general presentations (18 oral and 32 poster presentations).
Although the conference was held under the emergency declaration of new coronavirus infection, and was the first ever to be held via the Internet, more than 500 participants, including more than 430 registrants and invited lecturers, actively discussed in each section, providing an opportunity for useful information exchange across the boundaries between industry, academia, and government. The symposium was attended by more than 430 participants and invited lecturers. The following is a summary of one symposium and four poster presentations.
Symposium 8: Drug Development in a Changing Environment in Light of the Corona Disaster
The theme of the symposium was "Drug Development in a Changing Environment in Light of the Corona Disaster," chaired by Yuji Kashiwatani, Chairman of the Pharmaceutical Affairs Committee of the Pharmaceutical Association of Japan, and Hiroshi Matsuzawa, Chairman of the Clinical Evaluation Subcommittee of the Pharmaceutical Evaluation Committee of the Pharmaceutical Association of Japan.
Fig. 1 Slides of the day
First, as topics related to clinical trials, Yukari Suzuki of the Core CRC Office, Implementation Support Division, Center for Clinical Research Promotion, Niigata University Medical and Dental Hospital spoke about the challenges of clinical trial operations experienced during the spread of novel coronavirus infection from the standpoint of medical institutions and how to ensure quality in the future. Mr. Hiroshi Yanaginuma, Assistant Director, Drug Evaluation and Management Division, Pharmaceuticals and Life Health Bureau, Ministry of Health, Labour and Welfare, gave a presentation on changes in the clinical trial environment and ensuring reliability in clinical trials using online technology. He discussed the changes in the clinical trial environment and the use of online technology to ensure the reliability of clinical trials.
Next, on the topic of post-approval conformity surveys, Mitsumine Yamaguchi, Investigator, Reliability Assurance Department, Pharmaceuticals and Medical Devices Agency (PMDA), gave a presentation by Natsuko Hamada, Member of the Pharmaceutical Affairs Committee, Application and Regulatory Affairs Subcommittee, Pharmaceutical Manufacturers Association of Japan, on the details of the study and current status from the first emergency declaration to the start of remote surveys, Ms. Natsuko Hamada, a member of the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), gave a presentation on the use of remotes in post-application conformity assessment and other issues (from a pharmaceutical company perspective).
In the general discussion, there was a question-and-answer session on the content of each presenter's presentation, as well as a discussion on the challenges faced by the industry as a result of the change in communication methods from face-to-face to web-based communication.
Panel discussion by the chairperson and speakers
In closing, the chairperson emphasized the importance of getting to know each other well in order to ensure mutual trust, as well as the importance of communication between the public and private sectors through their respective efforts, even in different situations, although there are difficulties in communication in situations where they cannot meet in person during normal times, such as in the implementation and monitoring of clinical trials and communication during remote surveys. He concluded by commenting that, even in different situations, the public and private sectors have been able to exchange useful opinions by devising ways to communicate with each other.
Distribution status from the Pharmaceutical Cooperative Meeting Room
General Abstract (Poster)
The Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) presented posters on the following four topics.
The posters were posted as PDF files on the Web, and during the discussion time, the presenters and participants were connected online in the breakout room to exchange opinions, which was an unprecedented response in previous years.
The results of a questionnaire survey conducted to understand the actual situation and factors behind the application lag were presented by Dr. Wu-San and other committee members. The survey was conducted on the application lags for drugs with new active ingredients approved from April 2018 to March 2020 and for new drugs approved for pediatric indications. The results suggest that participation in global clinical trials and simultaneous application are effective in reducing the application lag, and further progress in these areas is expected to lead to the elimination of the application lag. Regarding the development of pediatric indications, the committee indicated that it would continue to investigate whether the new indication and the extension of the reexamination period for adult indications for pediatric development would accelerate the development of drugs for pediatric patients.
Dr. Kyoki Hojo and other committee members spoke on the theme of "Current Status of Development Projects at Member Companies of the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ): Consideration from the Global Development Implementation Status, The theme of the meeting was "The current status of development projects at the member companies of the Pharmaceutical Cooperative Association of Japan (PPCJ)", "More efficient global development strategies", and "Development in Japan based on the "General Principles for the Planning and Design of Global Clinical Trials" guidelines (ICH E17), which were implemented in June 2018". The results of the study focused on the "How should development in Japan be based on the "General Principles for the Planning and Design of Global Clinical Trials" guidelines (ICH E17) implemented in June 2018? The results of the analysis of 1,028 development projects showed that, similar to the trend up to 2020, a large percentage of the projects were for anti-cancer drugs, 45% in total, 49% for foreign capital, and 37% for domestic capital. Although the implementation of ICH E17 is progressing in many countries, efforts to develop a consolidation strategy are still not widespread, and the biggest challenge is thought to be the establishment of evidence to demonstrate the appropriateness of the consolidation strategy. The committee members indicated that they would like to continue to closely monitor the challenges of the consolidation strategy and to continue to examine ways to promote more efficient, high-quality, and speedy global development.
Under the theme of "Questionnaire on the Current Status of Face-to-Face Advice Provided by the Pharmaceuticals and Medical Devices Agency and Companies' Perceptions of the Current Status," Tadashi Sugihara and other committee members surveyed the current perceptions and requests for face-to-face advice provided from October 2019 to September 2020 by member companies of the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers' Association of Japan. As a result, the number of face-to-face advices implemented was 537, and the level of satisfaction was as high as in the previous survey, and no significant impact was found due to changes in the response and consultation format in the Corona Disaster. Many companies considered the face-to-face advice in the form of web conferencing, which was started after the Corona Disaster, to have been beneficial, indicating that flexible selection of the meeting format after the end of the Corona disaster may increase user convenience. This presentation received the 11th Best Poster Award.
Under the theme of "Changes in the description in the manufacturing method section of the approval certificate during the product lifecycle - with a view to implementation of ICH Q12 -", Dr. Shimizume and his colleagues examined manufacturing and quality management based on PQS activities, with a focus on the establishment of a robust quality management system (mainly PQS) including risk management to ensure a stable supply of high quality pharmaceutical products with a view to the implementation of ICH Q12 in Japan. We focused on manufacturing and quality control based on the establishment of a robust quality management system (mainly PQS), including risk management, and examined the contents of the description in the approval document based on PQS activities. As a result, we found that PQS results are useful as a basis for the deletion of residual solvents in the process control of approval documents, and that many of the anticipated change cases require a partial change approval application, which is a hurdle for reviewing the contents of approval documents based on PQS results. It was indicated that expanding the consultation system with the regulatory authorities would contribute to the efficiency of pharmaceutical procedures.
Closing Remarks
This year's Annual Meeting was held via the web for the first time due to the measures taken against new coronavirus infection, but the secretariat and other related people made a great effort to hold the meeting based on the belief that it is important to create an opportunity to present the latest findings from the members of the Society. Although face-to-face communication was not possible, participants were able to participate from anywhere with a computer or other equipment and a communications environment, and they were able to ask questions to the lecturers easily using the Q&A function. New attempts were also made to make it possible to listen to multiple abstracts at the same time by streaming them on-demand for a certain period of time after the conference.
Eleven years have passed since the Society for Regulatory Science was established, and the number of members has exceeded 1,000, with progress being made in the collaboration between industry, academia, and government, which was the original goal of the Society. As the theme of this year's symposium, "Regulatory Science to Accelerate Social Implementation," suggests, there were no abstracts that referred to the definition of regulatory science in the symposium or general abstracts, but rather, the theme was how to address issues that exist today by utilizing regulatory science for social implementation, A wide range of discussions were held from various angles in industry, academia, and government. It is expected that the activities of the society will become more and more active along with the further development of regulatory science in the future.
( Hironori Takayama and Masatsugu Kobayashi, Pharmaceutical Affairs Committee)