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Talk Global Insights track

S0404 - Japan Townhall

Tue, Mar 18, 2025 · 3:10–4:20 PM CET Shanghai 1-2 Room, Congress Center Basel

About this session

In Japan, industry, regulatory authorities, and academia are working together to improve patient access to innovative new drugs. In line with this, PMDA has initiated a new 5-year plan to promote access since April 2024. This session will focus on the attractiveness of developing and obtaining marketing approval for pharmaceutical products in Japan from both regulatory and industry perspectives.

1. Introduction to the Pharmaceuticals and Medical Devices Agency’s (PMDA’s) Plan and the Direction to Achieve It
2. Clarifying Misconceptions and Urban Legends About the Drug Development Environment, and Providing an Update on the Latest Situation in Japan
3. The Attractiveness of Performing Drug Development in Japan, from Both Regulatory and Industry Perspectives

Programme:
- 3 Japan's Attractiveness for Drug Development — Shinichi Noda
- 4. Panel Discussion — Meni Melek
- 2 Japan’s attractiveness for drug development — Eri Sekine
- 1. Setting the scene — Daisuke Tanaka

Speakers

  • Daisuke Tanaka

    Office Director, Office of International Programs · Pharmaceuticals and Medical Devices Agency (PMDA)

    Chair

  • Meni Melek

    Regulatory Affairs Head, International · Novartis

    Panelist

  • Shinichi Noda

    Division Director · Pharmaceuticals and Medical Devices Agency

    Speaker

  • Eri Sekine

    Executive Vice President · CMIC CO., LTD

    Speaker