The Second Indonesia - Japan Symposium

May 13, 2014
Pharmaceuticals and Medical Devices Agency (PMDA)

Scope

    While pharmaceutical development and manufacture have being globalized, Asia is getting its importance in clinical development, supplying drug substances, and manufacturing drugs, as well as the market of medical products. Therefore, it is inevitable for Japan to enhance collaboration with Asian countries. Under the circumstances, we are pleased to announce on holding the second Indonesia – Japan Symposium scheduled on May 21^st, 2014 in Jakarta, Indonesia.
    In the symposium, representatives from regulatory agencies and the drug industries from both Indonesia and Japan will give presentations on update of pharmaceutical situations, safety measures such as GMP, pharmacopoeia, etc. Also, presenters will directly respond to the questions from audience. This symposium aims at the participants better understand each other’s regulatory system and then stimulate further expansion and development of medical products.

Host

Pharmaceuticals and Medical Devices Agency (PMDA)
Japan Pharmaceutical Manufacturers Association (JPMA)
National Agency of Drug and Food Control (NADFC)
Gabungan Perusahaan Farmasi Indonesia (GPFI)

Date (The symposium was already held.)

May 21, 2014 (Wednesday)
9:00~16:40

Venue

Novotel Mangga Dua, Jakarta, Indonesia

Quota

Quota: 250
Close the list when the registration reaches 250.

Registration

This symposium is designed for staff members of Indonesian regulatory agency and pharmaceutical companies based in Indonesia. For registration, please contact National Agency of Drug and Food Control (NADFC) directly.
Participants from Japan, please contact Pharmaceuticals and Medical Devices Agency (PMDA).
(https://www.pmda.go.jp/english/contact/index.html)

Language

Japanese - Indonesian simultaneous interpretation is provided.

Program

Opening remarks

9:00~9:20

Bpk. Johannes Setijono (Chairman / Executive Director, GPFI) Mr. Haruhiko Hirate (Chairman, International Affairs Committee, JPMA) Ms. Antonia Retno Tyas Utami (Deputy I, NADFC) Dr. Taisuke Hojo (Senior Executive Director, PMDA)

Key-note speech

9:20~9:30	Mr. Shinobu Uzu (Office Director, Office of New Drug I, PMDA) New Challenges of PMDA & New Drug Development in Asia
9:30~9:45	Ms. Antoia Retno Tyas Utami (Deputy I, NADFC) Ensuring and Enhancing Quality Assurance of Medical Products

Theme 1: GMP: Risk Management/Assessment related to Product Recall

10:15~10:45	Dr. Ichiro Tsunoi (Office of GMP/QMS Inspection, PMDA) PMDA update on GMP & QRM related to recall
10:45~11:15	Mr. Sumarno (GMP Expert, NADFC) Product Recall - Risk Assessment
11:15~12:00	Discussion

Theme 2: Voluntary Recall of Pharmaceuticals

13:00~13:30	Mr. Masato Kawamoto (Quality & Technology Committee, JPMA) Voluntary Recall
13:30~14:00	Mr. Sumarno (GMP Expert, NADFC) Voluntary Recall of Pharmaceuticals
14:00~14:30	Discussion

Theme 3: Database & Control of APIs (Active Pharmaceutical Ingredients), APAC Outcomes

14:45~15:15	Ms. Ratna Irawati (Database & Control of APIs, NADFC) Control of Active Pharmaceutical Ingredients
15:15~15:45	Dr. Kozo Akasaka (Director, International Affairs Department, JPMA) APAC Harmonization: New Activities
15:45~16:00	Mr. Parulian Simanjuntak (International Pharmaceutical Manufacturer Group (IPMG)) APAC from the Indonesian Perspective
16:00~16:30	Discussion

Closing Remarks

16:30~16:35	Dr. Hideaki Ui (Division Director, Office of International Programs, PMDA)
16:35~16:40	Ms. Augustine Zaini (Director, Therapeutic Products and Household Medical Supplies Standardization, NADFC)