March 13, 2017
Pharmaceuticals and Medical Devices Agency
Globalization of research and development, manufacturing and marketing of medical products has progressed, and cooperation in regulatory activities amongst regulatory agencies has become necessary. Nowadays, Asian countries have become significant in the area of clinical development and manufacturing of medical products, and therefore, PMDA strives to strengthen the collaborative relationship with the Asian regulatory agencies.
In this symposium, representatives from regulatory agencies and the drug industries from both Indonesia and Japan will give presentations on regulatory updates, regulatory schemes including orphan drug regulation, pharmacovigilance activities including Risk Management Plan (RMP), etc. Also, presenters will directly respond to the questions from audience. This symposium aims at the participants’ better understanding of regulatory systems in Indonesia and Japan, and then to stimulate further expansion and development of medical products.
Badan Pengawas Obat dan Makanan (BPOM)
Pharmaceuticals and Medical Devices Agency (PMDA)
Gabungan Perusahaan Farmasi Indonesia (GPFI)
Japan Pharmaceutical Manufacturers Association (JPMA)
May 16, 2017 (Tuesday)
TBD (Jakarta, Indonesia)
Simultaneous interpretation (Japanese to Indonesian and vice versa)
Major topics will be:
|Japan:||Office of International Cooperation,
Parmaceuticals and Medical Devices Agency