On Monday, September 22nd, we held the "Plug and Play x Nakanoshima Qross Co-hosted Event - Trends in domestic and international regulations for drug discovery and medical devices."

On Monday, September 22nd, the "Plug and Play x Nakanoshima Qross Co-hosted Event - Trends in Domestic and International Regulations for Drug Discovery and Medical Devices" was held at the Qrossover Lounge Yume on the second floor of Nakanoshima Qross.

This event focused on regulatory affairs (approval applications, quality control, etc.), which are essential for the growth of biotech and medtech startups, and was held as an opportunity to learn about specialized knowledge and the latest trends in domestic and international pharmaceutical regulations.

At the beginning of the event, Jun Miyagawa, Assistant to the President of the Future Medicine Promotion Organization and CEO of MIRACLE SCIENCE INNOVATION Co., Ltd., introduced the industry-academia collaboration and startup support initiatives in the life sciences field that are being carried out at Nakanoshima Qross.

Next, Lidia Cánovas (pharmaceuticals) and Talyta Carteano (medical devices) from Asphalion, a European-based regulatory consulting firm, took the stage. They gave specific explanations based on their practical experience on the differences and similarities between pharmaceutical regulations in Europe, the United States, and Japan, as well as the pharmaceutical approval process.

Additionally, Kazuo Miyazaki, CEO of Mican Technologies Inc., which is currently establishing a subsidiary in Germany, gave a very realistic talk about his experience dealing with domestic and international regulations and the challenges of expanding globally in the field of regenerative medicine.

In the subsequent cross-talk session, Moriguchi Yu, specially appointed lecturer in the Department of International Future Medical Studies at the Osaka University Graduate School of Medicine and expert supporter at the Future Medical Promotion Organization, also joined in, and opinions were exchanged from various perspectives on the relationship between the advancement of AI technology and regulations, as well as the challenges and strategies that Japanese startups face when expanding overseas.

At the end of the event, a stand-up networking session was held, where speakers and participants actively interacted with each other. Over delicious food, it was an opportunity to forge diverse connections around the common theme of pharmaceutical affairs and regulations.