Mon. Mar 27, 2023 1:50 PM - 3:50 PM [Room M2] The Alumni Hall "Frate": Seminar Room (1F)

Organizer: Masuo Kondoh, Tetsuya Kusakabe

Medical products should be developed in compliance with internationally harmonized regulations to ensure their quality, efficacy and safety. Various regulations have been introduced to maintain and improve the quality of medical products, even after distribution, to ensure proper use and to prevent counterfeit drugs and defective products from entering the market. Such regulations must be strict; however, it is essential that they are realistic for clinical use and are appropriately harmonized with the intended use of the medical product, rather than becoming an obstacle to translation of the medical innovation to medical care and therapy.
In the 140^th meeting, we initiated discussion about how innovation should originate from Japan via the mutual penetration of regulations and innovation. Discussion on the paradigm shift of medical innovation by digital transformation was deepened in the 141^st meeting.
In the upcoming 143^rd meeting, symposiasts from industry, academia, and government will convene to present the latest developments in pharmaceutical regulations, improvement of drug discovery, functional foods, in vitro human evaluation systems, in vitro diagnostics, and human resource development strategies. We will discuss how medical innovation should be promoted by harmonization of innovation and regulation.