Newsletter November 2023 No.218
Top News
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.
Topics
- Held the 50th GMP Case Study Workshop in 2023
- The 13th Annual Meeting of the Regulatory Science Society of Japan held
- Held "Economic Security and Cyber Security" seminar
- Toward the Utilization of Health Care Data and Real World Data Next Generation Medical Infrastructure Act and the Pharmaceutical Manufacturers Association of Japan
- Aiming to improve efficiency of case data recording and collection in clinical trials - Utilization of data linkage based on standardization of electronic medical record data such as HL7 FHIR
- About the Code Understanding Promotion Month in 2023
- Held "Meeting of Code Administration Managers and Practitioners for 2023
- Joint Symposium of the Pharmaceutical Cooperative Aging Group and the Health Policy Institute of Japan (HGPI)
Health Challenges Associated with Aging, Dementia and Cancer - Early Approaches to Extending Healthy Life Expectancy
Policy Research Institute page
From JPMA
Toward Building a Drug Discovery Ecosystem in the Infectious Disease Field