Pharmaceutical and Medical Device Regulatory Science

Standardizing Site Documentation（Issue C）for the FY2025 Clinical Trial Ecosystem Project Takahiro SAKAI, Yasutoshi KUBOKI
Toward a Better Clinical Trial Environment in Japan　— Expectation for Synergistic Effects from the Implementation of ICH E6（R3） and the Introduction of the Clinical Trial Ecosystem— Mitsune YAMAGUCHI
Considerations on Quality Evaluation for Targeted mRNA-LNP Drug Products Shizu TSUKADA, Saori ISHIOKA, Hiroaki ARAI, Rei OKAZAKI, Takuya SUZUKI, Takayuki FUKUYAMA, Yu YOSHIOKA, Takeshi TERADA, Shohei TAKASUGI, Hiro HONDA, Ryohei TOGASHI, Kohei KUBOTA, Takayuki MORISE, Naoki TAKAHASHI, Shohei HACHIYA, Kohei OGAWA, Kosuke KAKITA, Yusuke NAGATO, Yasuhiro ABE, Hiroko SHIBATA, Masato KIYOSHI, Akiko ISHII-WATABE, Takashi NAKAMURA, Tomomi SATO
Pharmaceutical Industry Challenges in Enhancing the Clinical Trial Environment in Japan Masaaki JITSU, Kiyomi HIRAYAMA, Tomohiro UCHIDA