September 22, 2021
Pharmaceuticals and Medical Devices Agency
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.
Ministry of Health, Labour and Welfare (MHLW)
Pharmaceuticals and Medical Devices Agency (PMDA)
Japan Pharmaceutical Manufacturers Association (JPMA)
Tuesday, December 14, 2021, 10:00 - 16:35
This seminar will be held in two formats: the in-person format and the online format.
Tokyo Conference Center Shinagawa
Area Shinagawa 5th Floor, 1-9-36 Konan, Minato-ku, Tokyo
2 minutes by foot from JR Shinagawa Station East Exit
Depending on how the COVID-19 infections will trend as we approach the date of the seminar, the seminar format may become online only.
English-Japanese consecutive translation is provided only in the Panel Discussion in Session 1.
|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
|Current Status and Scope of Q Guideline
Speaker: MATSUDA Yoshihiro (PMDA)
|13:20 - 13:50
|Topics from Q2(R2)/Q14 Draft Guidelines
Speaker: HIYAMA Yukio (National Institute of Health Sciences)
|13:50 - 14:20
|Q13 Continuous Manufacturing of Drug Substances and Drug Products
Speaker: MATSUI Yasuhiro (JPMA)
|14:20 - 14:40
|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)