November 1, 2022
Pharmaceuticals and Medical Devices Agency
This timely forum aims for a better understanding about the updates of efficacy guidelines regarding clinical trial. In this forum, experts who are working on the E8(R1), E6(R3) and E19 guidelines will present the overviews as well as a panel discussion.We will also hold a panel discussion about the future work of ICH.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) decided to revise the ICH E8 guideline and the ICH E6 guideline as a part of the council’s “GCP Renovation” which was adopted in 2017.
The E8 guideline has reached Step4 in October 2021. The E6 guideline is under consideration in the Working Group since November 2019 and is expected to reach Step1 in November 2022. The ICH E19 guideline was decided to develop in 2016 and has reached Step4 in September 2022.
We hope that this forum will promote understanding of the ICH guidelines and proper use by sharing the latest status of each guideline with the participants.
Ministry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)
Japan Pharmaceutical Manufacturers Association (JPMA)
Thursday, December 8, 2022, 10:30 - 17:00
This forum is held in two formats: the in-person format and the online format.
Area Hamamatsucho Basement 1st Floor 2-4-1 Shibakouen, Minato-ku Tokyo
7 minutes by foot from JR Hamamatsucho Station North Exit
3 minutes by foot from Daimon Station A6 Exit
3 minutes by foot from Shibakouen Station A3 Exit
Depending on the situation of COVID-19, the forum format may become online only.
English-Japanese consecutive translation is provided only in the Panel Discussion in Session 1.
|10:30 - 10:40||Opening Remarks
Speaker: YAMAMOTO Fumi (MHLW), MORI Kazuhiko (JPMA)
|<Session 1> Moderator: OGAWA Kaori (PMDA)|
|10:40 - 11:10||Keynote Session: PMDA Latest Update
Speaker: FUJIWARA Yasuhiro (PMDA)
|11:10 - 11:20||ICH Awarding ceremony|
|11:20 - 12:05||Panel Discussion: Future Work of ICH
Chairs: NAKASHIMA Nobumasa (PMDA), YANAGISAWA Manabu (JPMA)
Panellists: Theresa Mullin (FDA)
YASUDA Naoyuki (MHLW)
YOKOTA Masafumi (JPMA)
|12:05 - 13:10||Lunch Break|
|<Session 2> Moderator: KATO Mariko (JPMA)|
|13:10 - 13:20
|Current Status and Scope of Efficacy Guideline
Speaker: ANDO Yuki (PMDA)
|13:20 - 13:50
|E8(R1) Overview and Current Status
Speaker: SAKAGUCHI Hiroshi (PMDA)
|13:50 - 14:20
|E6(R3) Overview and Current Status
Speaker: OBA Izumi (PMDA)
|14:20 - 14:50
Speaker: NISHIOKA Kinue (PMDA)
|14:50 - 15:10||ICH Efficacy Guidelines: Looking back from the past
Speaker: MORI Kazuhiko (JPMA)
|15:10 - 15:35||Coffee Break|
|15:35 - 16:55||Panel Discussion: Toward efficiency/optimization of future pharmaceutical development (From the perspective of Efficacy Guideline)
Chairs: TAMIYA Kenichi (PMDA), MATSUZAWA Hiroshi (JPMA)
Panellists: YASUDA Naoyuki (MHLW)
ANDO Yuki (PMDA)
KOMURO Yoshiko (PMDA)
NISHIOKA Kinue (PMDA)
MORI Kazuhiko (JPMA)
KOMIYAMA Osamu (JPMA)
WATABE Yukiko (JPMA)
NAKAMURA Kenichi (National Cancer Center Japan)
|16:55 - 17:00||Closing Remarks
Speaker: UZU Shinobu (PMDA)