ASEAN-Japan Risk Management Plan Symposium and Seminar 2022

ASEAN-Japan Risk Management Plan Symposium and Seminar 2022
21 June 2022 -

Effective and safe medicine is essential to maintain and improve public health and it is the responsibility of regulators in all countries of the world to carry out their monitoring. Therefore, the global harmonisation of technical regulatory requirements for the approval of medicinal products and cooperation among the authorities is essential for realising product review and efficient exchange of safety information.

The Risk Management Plan (RMP) is a breakthrough developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to provide information on the safety profile of drugs.

The University of Indonesia (UI) through the Faculty of Pharmacy (FF) is trusted as the implementing agency of the ASEAN-Japan Risk Management Plan Symposium and Seminar 2022, co-hosted by the Indonesian Food and Drug Authority (BPOM RI) and the Pharmaceuticals and Medical Devices Agency (PMDA) Japan. This symposium and seminar, funded by the Japan-ASEAN Integration Fund (JAIF) as part of the project ASEAN-Japan Pharmaceuticals Training in Risk Management Plan, aims to enhance efforts to harmonise drug regulations among the ASEAN Member States.

The ASEAN-Japan RMP Symposium and Seminar 2022 was held virtually for three days, on 23-25 May 2022. The symposium which was held on the first day had discussion on pharmacovigilance activities in Japan, the current status of RMP and the perspective of regulators in Indonesia, and the role of labelling to minimise risks. On the next day, the seminar was held with the same focus as the symposium, which is to discuss the latest information related to RMP as an official regulation. The seminar is intended for regulatory staffs in ASEAN Member States. The speakers of the ASEAN-Japan RMP Symposium and Seminar 2022 are experts from PMDA Japan, Japan Pharmaceutical Manufacturers Association, and BPOM RI.

The PMDA also captured these events on their Newsletter June 2002 on page 2.