ICH Quality Forum

September 22, 2021
Pharmaceuticals and Medical Devices Agency

Introduction

Quality control of pharmaceutical drugs is essential for assuring efficacy and safety. Many ICH Quality Guidelines are now under development and being revised. Q2(R2)/Q14 and Q13 are about to reach Step 2. Q12 reached Step 5 in 2019 and is under implementation in Japan.
Those guidelines will improve the CMC process and accelerate the patients’ access to new pharmaceutical drugs.
In this forum, experts who are working on the Q2(R2)/Q14, Q13 and Q12 guidelines will present the overviews as well as a presentation and a panel discussion about Q12 and amendment to “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices”. We will also have a presentation about the updates of quality guidelines and a panel discussion about the latest views of ICH.
This forum providing opportunities to lead better public health and proper use of ICH guidelines.

Hosts

Ministry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)
Japan Pharmaceutical Manufacturers Association (JPMA)

Date and Time

Tuesday, December 14, 2021, 10:00 - 16:35

Seminar Format

This seminar will be held in two formats: the in-person format and the online format.

Venue:
Tokyo Conference Center Shinagawa
Area Shinagawa 5th Floor, 1-9-36 Konan, Minato-ku, Tokyo
(Directions)
2 minutes by foot from JR Shinagawa Station East Exit
https://www.tokyo-cc.co.jp/eng/shinagawa/index.html

Depending on how the COVID-19 infections will trend as we approach the date of the seminar, the seminar format may become online only.

Registration

Registration closed

• There is no registration fee for this seminar.
• Capacity will differ between the seminar 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=MTUxNw==&mode=3
Online format
https://www.praise-net.jp/pn/m/semi/top.asp?seminar_id=MTUxOA==&mode=3

• Registration can be made until Friday, November 26th.

Interpretation

English-Japanese consecutive translation is provided only in the Panel Discussion in Session 1.

Program

Time	Contents, Speakers (speakers will be)
10:00 - 10:10	Opening Remarks   Speaker: YAMAMOTO Fumi (MHLW), MORI Kazuhiko (JPMA)
<Session 1> Moderator: UEDA Mami (PMDA) English - Japanese consecutive translation is provided.
10:10 - 10:40	Keynote Session: PMDA Latest Update   Speaker: FUJIWARA Yasuhiro (PMDA)
10:40 - 11:50	Panel Discussion: Latest Work of ICH   Chairs: NAKASHIMA Nobumasa (PMDA), YANAGISAWA Manabu (JPMA)   Panellist: Theresa Mullin (FDA)                   Celia Lourenco (Health Canada)                   Peter K. Honig (Former SVP Pfizer R&D and Former PhRMA Representative)                   YASUDA Naoyuki (MHLW)                   EHARA Teruyoshi (PMDA)                   YOKOTA Masafumi (JPMA)
11:50 - 13:00	Lunch Break
<Session 2> Moderator:  YANAGISAWA Manabu (JPMA) Presentations are in Japanese only.
13:00 - 13:20 (incl. Q&A)	Current Status and Scope of Q Guideline   Speaker: MATSUDA Yoshihiro (PMDA)
13:20 - 13:50 (incl. Q&A)	Topics from Q2(R2)/Q14 Draft Guidelines 　Speaker: HIYAMA Yukio (National Institute of Health Sciences)
13:50 - 14:20 (incl. Q&A)	Q13 Continuous Manufacturing of Drug Substances and Drug Products 　Speaker: MATSUI Yasuhiro (JPMA)
14:20 - 14:40 (incl. Q&A)	ICH Q12 Technical and Regulatory Considerations for Pharmacutical Product Lifecycle Management 　Speaker: YAGI Satomi (PMDA)
14:40 - 15:00	Coffee Break
15:00 - 16:30	Presentation: Amendment to “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices” and Q12 Speaker: ARAKAWA Yuji (MHLW) Panel Discussion: Amendment to “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices” and Q12  Chairs: EHARA Teruyoshi (PMDA), NAKAGAWA Tomonori (JPMA)  Panellists: ARAKAWA Yuji (MHLW)                   MATSUDA Yoshihiro (PMDA)                   HARA Kentaro (PMDA)                   YAGI Satomi (PMDA)                   HIYAMA Yukio (National Institute of Health Sciences)                   WADA Masaaki (JPMA)                   KIBE Mayumi (JPMA)
16:30 - 16:35	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 seminar venue. This will be used in counting the number of people in the audience.
• Social distancing will be observed at the seminar 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).