March 5, 2013
Pharmaceuticals and Medical Devices Agency (PMDA)
Scope
The first Indonesia - Japan Symposium, which co-hosted by Pharmaceuticals and Medical Devices Agency (PMDA), Japan Pharmaceutical Manufacturers Association (JPMA), National Agency of Drug and Food Control (NADFC), and Gabungan Perusahaan Farmasi Indonesia (GPFI), was held on February 13, 2013 at Jakarta, Indonesia.
In the symposium, representatives from regulatory agencies and the drug industries from both Indonesia and Japan gave presentations on update of pharmaceutical situations, Pharmacovigilance and GDP of each country.
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.)
February 13, 2013 (Wednesday)
Venue
Redtop Hotel, Jakarta
| Address: | Jl. Pecenongan 72, Jakarta 10120, Indonesia |
| Tel: | +62-21-3500077 |
| Fax: | +62-21-3500055 |
| Web: | http://www.redtophotel.com/ |
Program
Opening remarks
- Drs. Johannes Setijomo, Apt (Chairman, GPFI)
- Dr. Akira Kawahara (Managing Director, JPMA)
- Dr. Tatsuya Kondo (Chief Executive, PMDA)
- Dra. Lucky S. Slamet, M.Sc. (Head, NADFC)
Key-note speech
- Mr. Shinobu Uzu (Office Director, Office of New Drug I, PMDA)
- Dra. A. Retno Tyas Utami, Apt, M.Epid. (Deputy of Therapeutic Products and Narcotic, Psychotropic & Addictive Substance Control, NADFC)
Overview of Pharmacovigilance and Good Distribution Practices: Program and Activities in Indonesia
Theme 1: Pharmacovigilance
- Dr. Shoji Takamatsu (Office Director, Office of Safety II, PMDA)
Present and Future of Drug Safety Measures in Japan
- Dra. Ratna Irawati, Apt, M.Kes. (Director for Distribution Control of Therapeutic and Household Healthcare Products, NADFC)
Pharmacovigilance System and Its Implementation in Indonesia
- Dr. Jarir Thobari, M.D., DPharm, Ph.D. (Faculty of Medicine, Gadjah Mada University)
Importance of Pharmacovigilance for Pharmaceutical Industry
- Discussion
Theme 2: GDP (Good Distribution Practice)
- Mr. Hiroshi Ichijo (Chairperson of the Pharmaceutical Regulation Committee, the Federation of Japan Pharmaceutical Wholesalers Association (JPWA))
Drug Distribution and GDP in Japan
- Mr. Erwin Tenggono (PT. Anugrah Argon Medica)
GDP Implementation: Business and Ethics
- Discussion
Closing Remarks
- Dr. Nobumasa Nakashima (Office Director, Office of International Programs, PMDA)
- Dra. A. Retno Tyas Utami, Apt, M.Epid. (Deputy of Therapeutic Products and Narcotic, Psychotropic & Addictive Substance Control, NADFC)