On Friday, December 12th, we will be holding the "Nakanoshima Qross Drug Discovery Cluster Campus Project PMDA Co-hosted Event: What are the regulations that accelerate innovation?"

On Friday, December 12th, the "Nakanoshima Qross Drug Discovery Cluster Campus Project PMDA Co-hosted Event: What are the regulations that accelerate innovation?" will be held at Nakanoshima Qross 1F Congress Square Osaka Nakanoshima (Square 323).
This symposium is being held in collaboration with the Pharmaceuticals and Medical Devices Agency (PMDA) as part of the "Nakanoshima Qross Drug Discovery and Practical Application Promotion Program Support Project," which was adopted as part of the Ministry of Health, Labour and Welfare's FY2024 supplementary budget project, the "Drug Discovery Cluster Campus Development Project."

As issues such as drug lag and drug loss become more apparent, early and constructive dialogue with regulatory authorities and a deeper understanding of the system are essential to rebuilding and re-strengthening Japan's drug discovery capabilities, particularly in order to lead the drug discovery seeds of startups and academia to practical application.

In collaboration with the PMDA, this symposium will share the latest regulatory trends in the Japanese market and efforts toward international harmonization. It will also discuss ways to promote both the global expansion of Japanese-originated drugs and the introduction of overseas drugs and capital through open innovation with diverse domestic and international players. The symposium will cover a wide range of areas, particularly regenerative medicine products, nucleic acid medicines, gene therapy, and CDMOs. By sharing awareness of the challenges faced by a diverse range of stakeholders, including industry, academia, financial institutions, medical institutions, regulatory authorities, and local governments, the symposium aims to accelerate the social implementation of innovative new drugs. Furthermore, it aims to continue the international exchange sparked by the Osaka-Kansai Expo and maintain and develop a sustainable global network even after the Expo ends.

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Date and time: Friday, December 12, 2025, 14:00-16:15 (networking until 18:00)
Location: Nakanoshima Qross 1F Congress Square Osaka Nakanoshima (Square 323)
Capacity: 100 people on-site, 200 people online
◆Participation fee: Free
◆Application:https://nq20251212.peatix.com/view
◆ Organizer: Future Medicine Promotion Organization
Co-hosted by: Pharmaceuticals and Medical Devices Agency
◆ Supported by: Osaka Prefecture
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■ Program
*Please note that the program may be subject to change without notice.
*Speakers' titles omitted

14:00-14:15 Opening remarks

• Organizer's greeting: Yoshiki Sawa (Chairman of the Board of Directors, Future Medicine Promotion Foundation)
• Co-host speech: Yoichi Onodera (Director of the Kansai Branch, Pharmaceuticals and Medical Devices Agency (PMDA))
• Greetings from Osaka Prefecture: Hirofumi Yoshimura (Governor of Osaka Prefecture (Video Message))
• Introducing the Drug Discovery Cluster Campus Project: Masahiro Mori (Minister's Secretariat, Ministry of Health, Labour and Welfare, Vice-Minister for Pharmaceutical Industry Promotion and Medical Information (online))

14:15-14:30 Organizer's Lecture: "Creating an Ecosystem at the International Center for Future Medicine Nakanoshima Qross"

• Yoshiki Sawa (President, Future Medicine Promotion Foundation)

14:30-15:00 Keynote speech

• Yasuhiro Fujiwara (President, Pharmaceuticals and Medical Devices Agency (PMDA))

15:00-15:10 Lecture: "Trends in the field of regenerative medicine"

• Ryosuke Maruyama (Director, Regenerative Medicine Products Review Division, Pharmaceuticals and Medical Devices Agency (PMDA))

==Break==

15:25-16:15 Panel discussion: "Regulations that accelerate innovation"

[Panelists]

• Yasuhiro Fujiwara (President, Pharmaceuticals and Medical Devices Agency (PMDA))
• Yoshiki Sawa (President, Future Medicine Promotion Foundation)
• Ryosuke Maruyama (Director, Regenerative Medicine Products Review Division, Pharmaceuticals and Medical Devices Agency (PMDA))
• Takaji Terai (Professor, Department of Gastroenterology, Niigata University Graduate School of Medical and Dental Sciences)
• Akihiko Kawakami (MEDISO Chief Project Manager, Drug Discovery and Health Ecosystem Division, Mitsubishi Research Institute, Inc.)

[Moderator]

• Yoichi Onodera (Director of the Kansai Branch of the Pharmaceuticals and Medical Devices Agency (PMDA))
• Other

16:15-16:30 Closing and commemorative photo

16:30-18:00 Networking (@Qrossover Lounge Yume)

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■ Contact:
Future Medical Promotion Organization　
Email:jimukyoku@miraikiko.jp