November 1, 2022
Pharmaceuticals and Medical Devices Agency
Introduction
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.
Hosts
Ministry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)
Japan Pharmaceutical Manufacturers Association (JPMA)
Date and Time
Thursday, December 8, 2022, 10:30 - 17:00
Forum Format
This forum is held in two formats: the in-person format and the online format.
Venue:
AP Hamamatsucho
Area Hamamatsucho Basement 1st Floor 2-4-1 Shibakouen, Minato-ku Tokyo
(Directions)
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
https://www.tc-forum.co.jp/ap-hamamatsucho/
Depending on the situation of COVID-19, the forum format may become online only.
Registration
Registration closed
- There is no registration fee for this forum.
- Capacity will differ between the forum formats; choice of in-person or online format will need to be made when registering.
- Please register through the following website. (Available only in Japanese)
in-person format
https://www.praise-net.jp/pn/m/semi/top.asp?seminar_id=MTYzNw==&mode=3
Online format
https://www.praise-net.jp/pn/m/semi/top.asp?seminar_id=MTYzOA==&mode=3 - Registration can be made until Thursday, December 1st.
- Questions for Efficacy Guideline can be accepted until Thursday, November 24th.
(The item of Questions in Registration form will be closed on November 24th.)
Interpretation
English-Japanese consecutive translation is provided only in the Panel Discussion in Session 1.
Program
| Time | Contents, Speakers |
| 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 (incl. Q&A) |
Current Status and Scope of Efficacy Guideline Speaker: ANDO Yuki (PMDA) |
| 13:20 - 13:50 (incl. Q&A) |
E8(R1) Overview and Current Status Speaker: SAKAGUCHI Hiroshi (PMDA) |
| 13:50 - 14:20 (incl. Q&A) |
E6(R3) Overview and Current Status Speaker: OBA Izumi (PMDA) |
| 14:20 - 14:50 (incl. Q&A) |
E19 Overview 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) |
Other Points to Note
- Participants for the in-person format will be asked to provide a print out of their registration confirmation email or their business card at the forum venue. This will be used in counting the number of people in the audience.
- Social distancing will be observed at the forum venue for the in-person format: no walk-ins will be allowed entry that day. Please make sure to register beforehand.
- In an effort towards a paperless briefing, printed materials will not be handed out at the venue. Briefing materials will be available on our website prior to the event. Participants are asked to prepare beforehand by bringing their own copies (printed or downloaded on their mobile devices).