Pharmaceuticals and Medical Devices Agency (PMDA) recently completed the PMDA-Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (ATC) RMP Seminar 2017 in Jakarta, Indonesia on May 18-19, 2017, with Japan International Cooperation Agency (JICA) as the co-host. This seminar was designed for officials working for Indonesian regulatory authorities, per request from National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan: BPOM). Total of 30 regulators joined the seminar.
The seminar opened with remarks by Mr. Shinobu Uzu, Chief Safety Officer, Mr. Shunsuke Takatoi, Senior Representative, JICA Indonesia Office, Mr. Masahiro Takahata, First Secretary, Embassy of Japan in Indonesia, and Dra. Nurma Hidayati, Deputy for Therapeutic Product and Narcotics, Psychotropic, and Addictive Substance Control, BPOM. The seminar consisted of 5 sessions whose topics were about pharmacovigilance, Risk Management Plan (RMP) in particular (see agenda for details).
The program were provided as lectures basically, but in an interactive manner with some questions to participants. Also, many questions were raised by participants in the Q&A time of each session. Participants enthusiastically engaged in discussions throughout the seminar.
In total, 6 staff members from PMDA contributed to the seminar.
At the end of the seminar, certificates for course completion were awarded to each participant by Dr. Junko Sato, Office Director, Office of International Cooperation, and Mr. Masahiko Yokota, Chief Advisor, JICA.
Lectures were provided by experts in RMP related regulatory activities. The participants enthusiastically asked many questions.
Comments from the participants:
"Very well presentation. The topic is very interesting, completed with detailed information regarding pharmacovigilance system in Japan. The cases and examples of cases made the presentation become more interesting. The lecturer also has a very good knowledge of this topic."
"It’s excellent for Japan to regulate the labeling in order to maximize drug safety (pre-market). I hope that information in this presentation will help BPOM, to strengthen the registration process and control to contribute in the post-market activities."
"A great and comprehensive presentation. This is the exact topic that we’re looking for since Indonesia will start to implement RMP. The information given are easy to understand and contain detailed explanation regarding RMP and its implementation in Japan. However, we still need guidance on how to compile RMP guideline which will be used in Indonesia. I hope there will be a continuous communication between BPOM and PMDA facilitated by JICA, in order to develop PV system in Indonesia."
"The presentation topics are very useful for us BPOM, as we are in the process of strengthening our pharmacovigilance system, and also starting to implement RMP in our drug regulation. We are very grateful to the presenters for delivering good presentations and having broad knowledge on the topics."
"The content of the seminar is very useful, enriches my knowledge about how to provide "drug safety". Hopefully it can be adopted in Indonesia."
"In general the implementation of the training is quite good. Training materials provide enough knowledge related to pharmacovigilance and about RMP that I have never been exposed to."
"Very good. This seminar can improve my knowledge especially about pharmacovigilance, which is a new skill for me. I hope by following this seminar, I could implement that to our country/region, so Indonesia will be as the same as Japan… someday…"
PMDA-ATC Seminars are held periodically, with a different theme for each seminar.
The Seminar announcements are posted on this page.
For any questions regarding PMDA Training Seminar, please contact us by clicking on the "Contact us" logo on top of the website, or please contact the Secretariat (e-mail: PMDA-ATC●pmda.go.jp).
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