5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
JPeDNet - Japan Pediatric Society Drug Development Network |
|
| Evidence of collaboration with regulatory authorities | Yes | Committee of Pharmaceutical Affairs communicate closely with the relevant divisions of the Ministry of Health, Labour and Welfare (MHLW) and also Pharmaceuticals and Medical Devices Agency (PMDA). There have been symposium co-sponsored by the JPeDNet and PMDA and/or JPMA. The symposium organized by JPeDNet almost always have speakers from the MHLW. |
| Capacity to provide competent consultation to regulatory authorities | Yes | Junko Sato, one of the external members of the Committee of Pharmaceutical Affairs belongs to PMDA. Whenever necessary, MHLW and/or PMDA request the JPS to provide expert advice. The advice is given by the member of the Committee on Pharmaceutical Affairs (CPA) and/or specialists designated by the CPA. |
| Formal meetings for clinical trials | No | Meetings for clinical trials are coordinated by industries sponsoring clinical trials. JPeDNet collaborates with this kind of activity. |
| Training courses given over the last 2 years | No | JPedNet itself does not give training courses. PCTN, Japan, does. |
| Training courses received over the last 2 years | No | JPedNet itself does not give training courses. PCTN, Japan, does. |
| Promotion of participation in clinical trials in countries with limited resources | No | None |
| List of Countries |