Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "PMDA-ATC RMP Seminar 2017 in Jakarta, Indonesia" for officials from Indonesia who are engaged in regulatory activities related to Risk Management Plan (RMP).
The Seminar will be offered by the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC), with Japan International Cooperation Agency (JICA) as the co-host, at Badan Pengawas Obat dan Makanan (BPOM) office in Jakarta, from May 18 to 19, 2017.
At this sminar, the details of regulatory activities for risk management of pharmaceuticals including labeling, risk minimization and risk communication will be shared. Discussions among participants are planned as well.
The aims of the Seminar are to provide the participants with chances to refer back to their work and to find any additional opportunities for enhancement of the participants' regulatory system.
The seminar is only for regulators working for Indonesian regulatory authorities (not open to those from other countries/regions).
Participation of many Indonesian regulators is expected.
Key Seminar Objective
- To learn basics of regulations and regulatory organization.
- To learn the key regulatory flow of the risk management.
The Seminar will focus on the following key regulatory activities.
- Labeling
- Risk minimization
- Risk communication
- To make use of the learnings from discussions and reflect it back to the regulatory system in the participant's organization.
Who should apply
- Officials from Indonesian regulatory authorities who are currently engaged in regulatory activities related to RMP.
- A basic knowledge of the regulations pertaining to the risk management of pharmaceuticals in his/her organization is required.
- The training will be provided in Japanese with consecutive interpretation into Indonesian.
- All participants are expected to actively participate in all of the sessions.
Date / Time
May 18 to 19, 2017. See attached draft program for schedule.
(On May 17, a preparation meeting for Seminar participants is organized by BPOM by JICA.)
Program (subject to change)
See attached draft program.
Registration
Registration will be internally gathered by BPOM.
Fee
There is no registration fee for this seminar.
Location
Lumire Hotel & Convention Center
Jl. Senen Raya No.135, Jakarta 10410, Indonesia
Contact Us
For more information, please contact:
Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC@pmda.go.jp
Office of International Cooperation
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan