The USP-MHLW/PMDA Joint Workshop has successfully concluded. Thank you for your attendance.
The United States Pharmacopeia (USP) and the Japanese Pharmacopoeia (JP)/the Ministry of Health Labour, and Welfare (MHLW)/Pharmaceutical and Medical Devices Agency (PMDA) have a long history of collaboration and cooperation, and have developed an effective working partnership in the contribution to global public health. And USP and the JP have been working together on harmonization for wide variety of active pharmaceutical ingredients (APIs), formulations and excipients, as well as their standard test methods, with the goal to ensure that patients have trust in their medicines. We held the Joint USP-MHLW/PMDA Workshop “Role of Quality in Pharmaceuticals” in June 2021, and discussed the past cooperation between USP and MHLW/PMDA, future prospects, and activities of both parties on important issues.
USP and MHLW/PMDA will hold a second joint workshop following above on initiatives related to pharmaceutical quality on September 10 (Tuesday) and September 11 (Wednesday), 2024. The purpose of the workshop is to discuss the latest efforts of USP and MHLW/PMDA/JP to ensure pharmaceutical quality in Japan and the East Asia, as well as the prospects for the pharmaceutical industry, government agencies, and pharmacopeias.
Potential topics for the workshop include harmonization of standards for pharmaceutical quality that USP and MHLW/PMDA/JP have been working on. In addition, new and emerging areas for USP and MHLW/PMDA/JP collaboration may be explored, including qNMR and complex generics. Furthermore, the workshop will explore topics related to the quality of pharmaceutical excipients such as diethylene glycol (DEG) and ethylene glycol (EG) issues, and updates from Japan and the U.S. on Nitrosamines.
Date/Time
September 10 (Tuesday), 2024: 12:30 to 17:00 JST (UTC+9)
September 11 (Wednesday), 2024: 9:30 to 14:15 JST (UTC+9)
Workshop Format
Hybrid style including live webcast
(Note: For virtual participation, a participation link will be sent to those who have registered.)
(Note: Please note that on-site participation is on a first-come, first-served basis.)
Location
Iino Conference Center Room B
4F Iino Building, 2-1-1 Uchisaiwaicho, Chiyoda Ward, Tokyo
Iino Conference Center - Location and transportation (external website)
Target Audience
Industry, academia, and regulator from Japan and East Asia.
Medical workers and patients are also welcomed.
Registration Fee
There is no registration fee for this seminar.
Organizer
MHLW, PMDA, USP
Program
September 10 (Tuesday)
12:00 to 12:30 JST (UTC+9): Registration
12:30 to 13:30 JST (UTC+9): Opening remarks
- USP Overview and Global Impact USP[1.75MB]
Ron Piervincenzi (USP CEO) - PMDA Updates and Recent Cooperation with USP[1.84MB]
Hiroshi Suzuki (Executive director, PMDA)
13:00 to 14:45 JST (UTC+9)
Session 1: Advancing Harmonization of Standards
ICH-Q14 and ICH-Q2
- Q2(R2)/Q14：Summary and JP perspective[1.19MB]
Hiroko Shibata (National Institute of Health Sciences (NIHS))
- ICHQ14 and USP Chapter <1220>: Historical perspective and the path forward in Analytical QbD[865KB]
Horacio pappa (USP)
USP-JP Prospective Harmonization
- Overview of Pharmacopeial Convergence and Harmonization: Pilot for USP- JP Prospective Harmonization Project[1.28MB]
Kevin Moore (USP)
- Challenges on USP-JP harmonization from Pilot Project on drug substances and drug products monographs[301KB]
Tatsuo Koide (NIHS)
- AstraZeneca's Perspective on the Prospective Harmonisation pilot[992KB]
Ryo Kondo (AstraZeneca), Edward Bush (AstraZeneca)
Panel Discussion
Panelists: Hiroko Shibata (NIHS), Horacio pappa (USP), Kevin Moore (USP), Tatsuo Koide (NIHS),
Ryo Kondo (AstraZeneca), Edward Bush (AstraZeneca)
Moderator: Hikoichoro Maegawa (PMDA)
14:55 to 16:55 JST (UTC+9)
Session 2: Excipient Quality
- Testing of Ethylene Glycol and Diethylene Glycol in High-risk Excipients[1.74MB]
Catherine Sheehan (USP), Jenny Liu (USP)
- Current Regulatory Landscape of Pharmaceutical Excipients in Japan[1378KB]
Yasuhiro Abe (NIHS) - Detecting and Managing Excipient Quality Issues: Singapore’s Experience[1,136KB]
Tan-Koi Wei Chuen (Duke-NUS Centre of Regulatory Excellent, Singapore) - The Problem of Ethylene Glycol and Diethylene Glycol Contamination
Paul Huleatt (Therapeutic Goods Administration, Australia) - Ethylene Glycol and Diethylene Glycol Contamination Cases Learnings and Regulatory Challenges[934KB]
Tri Asti Isnariani (Badan POM, Indonesia)
Panel Discussion
Panelists: Yasuhiro Abe (NIHS), Nguyen Thi Hong Hanh (Institute of Drug Quality Control, Vietnam),
Tan-Koi Wei Chuen (Duke-NUS Centre of Regulatory Excellent, Singapore),
Paul Huleatt (Therapeutic Goods Administration, Australia), Tri Asti Isnariani (Badan POM, Indonesia)
Moderator: Hikoichoro Maegawa (PMDA)
September 11 (Wednesday)
9:00 to 9:30 JST (UTC+9): Registration
9:30 to 11:00 JST (UTC+9)
Session 3: Future segment – what lies ahead?
Complex Generics
- Japanese Perspective on Complexity of Complex Generics[728KB]
Kumiko Sakai-Kato (Kitasato University)
- USP Initiatives for Complex Generics – Documentary and Physical Standards[777KB]
Prabhakar Reddy (USP)
Quantitative nuclear magnetic resonance (qNMR)
- qNMR in the Japanese Pharmacopoeia (JP), now and future[1.35MB]
Yukihiro Goda (NIHS)
Panel Discussion
Panelists: Kumiko Sakai-Kato (Kitasato Uuniversity), Prabhakar Reddy (USP), Yang Liu (USP),
Yukihiro Goda (NIHS)
Moderator: Kevin Moore (USP)
11:15 to 13:30 JST (UTC+9)
Session 4: Nitrosamines – Past, Present and Future
- Nitrosamine Impurities: Beyond a Compendial Standard – Learnings from USP’s Nitrosamines Exchange Community[2.74MB]
Naiffer Romero (USP), Mrunal Jaywant (USP)
- Approaches and considerations for N-nitrosamine issues from a quality perspective[3.32MB]
Yusuke Nagato (FUJIFILM Toyama Chemical)
- Past, Present (& Future) Regulation on Nitrosamines in Japan[2.9MB]
Tomoyuki Miyasaka (MHLW)
Lunch
Panel Discussion
Panelists: Mrunal Jaywant (USP), Yusuke Nagato (FUJIFILM Toyama Chemical), Tomoyuki Miyasaka (MHLW)
Moderator: Kevin Moore (USP)
13:30 to 14:00 JST (UTC+9): Way forward
- USP future perspectives[1,104KB]
Jaap Venema (USP)
- JP future perspectives[1,049KB]
Yoshiro Saito (NIHS)
14:00 to 14:15 JST (UTC+9): Closing remarks
Tomoyuki Miyasaka (MHLW)
Anthony Tann (USP)
(Note: Simultaneous interpretation between Japanese and English will be available.)
Registration
Registration has closed.
(Note: Acquired personal information (name, affiliation, and e-mail address) will be used jointly with PMDA, MHLW and USP, the co-sponsors of the workshop. This personal information shall only be used for organizing the workshop including the announcement, preparation of name plates, attendance confirmation, display of seating order, and sending and collection of questionnaires. Information will be handled appropriately in accordance with PMDA privacy policy.)