はじめに：近藤 昌夫（阪大院薬）
Session information
Symposium
[S43] Harmonization of pharmaceutical regulation and medical innovation: the cutting edge of medical innovation strategy
Mon. Mar 29, 2021 3:45 PM - 5:45 PM [Room H] Oral Presentation H (Online)
Organizer: Kusakabe Tetsuya (Pharmaceuticals and Medical Devices Agency), Kondoh Masuo (Grad Sch Pharm Sci, Osaka Univ)
The philosopher F. Engels described the transformation of quality and quantity as the “mutual penetration of polar opposites and transformation into each other when carried to extremes.” This raises the question of whether regulations are a roadblock for innovation. Medical products must be developed in accordance with regulatory frameworks to ensure their quality, effectiveness, and safety. After approval, medical devices are subject to a regulatory framework for post-marketing surveillance. A regulatory framework is needed to ensure that patients have access to safe medical products. However, sometimes, a series of regulatory frameworks ends up acting as a roadblock for, and thereby preventing, medical innovation, leading to delayed patient access to innovative products. By contrast, when regulation is optimal, it is not roadblock; rather, it is the actual pathway to achieving real and lasting innovation (Margaret Hamburg, 2012). Since we kicked off discussion on medical innovation by harmonization between regulation and innovation in the last symposium, paradigm shifts have been occurred by enforcement of the revised Pharmaceutical and Medical Device Act and digital transformation, or even by the worldwide spread of COVID-19 infection. In this symposium, symposists from regulatory authorities, academia, and industry will speak about recent topics in regard to the development and/or regulation of medical products. Subsequently, we will discuss the cutting edge of the harmonization with pharmacists and pharmaceutical scientists. We hope that this symposium will serve to promote interpenetration between the regulation and innovation of medical products, leading to initiatives for medical innovation in Japan.
3:45 PM - 4:05 PM
○Tetsuya Kusakabe1 (1. Pharmaceuticals and Medical Devices Agency)
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4:05 PM - 4:25 PM
○Katsuaki Ura1 (1. AMED iD3)
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4:25 PM - 4:45 PM
○Jun Kunisawa1 (1. NIBIOHN)
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4:45 PM - 5:05 PM
○Yasushi Okuno1 (1. Kyoto Univ., Graduate School of Med.)
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5:05 PM - 5:25 PM
○Akihiko Tsuruoka1, Junji Matsui2, Yasuhiro Funahashi1, Corina Dutcus2 (1. Eisai, 2. Eisai Inc.)
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5:25 PM - 5:45 PM
○Naoki Sogo1 (1. Astellas Pharma China, Inc., Development Division)
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おわりに：日下部 哲也（医薬品医療機器総合機構）