This Joint MHLW/PMDA-USP Workshop has ended. Thank you for attending.
The critical importance of quality for pharmaceutical medicines has never been more evident than it has been as the result of the COVID-19 public health crisis. Supply chains to bring quality medicines to patients have faced significant challenges, for example, the shutdown of certain manufacturing facilities, disruptions in transportation infrastructure and weaken urgent needs to find alternative sources of medicines. As a result, traditional approaches to bringing quality medicines to patients have undergone rapid change. Pharmacopeias, including the United States Pharmacopeia (USP) and the Japanese Pharmacopoeia (JP) have been working together on these critical issues facing medicine quality including setting specifications for wide variety of active pharmaceutical ingredients (APIs), formulations, excipients, and packages, as well as their standard test methods, with the goal to ensure that patients have trust in their medicines. USP and 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. As such, USP and MHLW/PMDA would like to promote a workshop on the topic of “Role of Quality in Pharmaceuticals” in East Asia including Japan by introducing our activities to ensure quality of medicines, the role we have played in the response to the current crisis and changes including global COVID-19 pandemic, and what this means for the future of the intersection of pharmacopeias, regulators, and industry in responding to a public health emergency, and how this may change our operations in the future.
Potential topics for the workshop include an analysis of supply chain vulnerabilities, and the roles that USP and MHLW/PMDA/JP can play in ensuring resilient supply chain. In addition, new and emerging areas for USP and MHLW/PMDA/JP collaboration may be explored, including examples such as Impurities Management, qNMR, and Biotechnological standards such as monoclonal antibodies and oligonucleotides. Furthermore, the workshop will explore ICH Quality Topics that intersect with USP and MHLW/PMDA/JP, specifically in the areas of Pharmaceutical Continuous Manufacturing, Analytical Method Validation, and Impurities (including mutagenic impurities).
USP and MHLW/PMDA look forward to your participation in our joint workshop!
Date and Time
JST Jun. 16 - 17, 2021 (EST Jun. 15 - 16, 2021)
Workshop Format
Virtual Meeting
Target Audience
Industry, academia, and regulator from Japan and East Asia. Doctors, medical workers, and patients are hopefully expected.
Host
Organizer: MHLW, PMDA and USP / Facilitator: PDA Japan
Program
English-Japanese Simultaneous Translation Available
<Day 1: JST June 16>
| Time | Contents, Speakers | ||
|---|---|---|---|
| 8:30~8:40 | Opening Remarks | Dr. Hiroyuki Arai, PMDA | |
8:40~9:05 9:05~9:15 |
Opening Session: Role of Pharmacopeia in the Pandemic Era Medicines quality throughout the COVID-19 pandemic: Collaboration and Trust” Q&A |
Dr. Ronald T Piervincenzi, USP |
|
9:15~9:50 |
(Policy) Session 1: Introduction of each Pharmacopeia Moderator: Dr. Kevin T Moore, USP |
||
| - USP Now and in the Future - Introduction of the Japanese Pharmacopoeia - PMDA’s activity against COVID-19 |
15 min 15 min 5 min |
Mr. Mario Sindaco, USP Dr. Yukihiro Goda, NIHS Mr. Kenichi Mikami, PMDA |
|
| 9:50~10:05 | Break | ||
| 10:05~10:45 | Session 1 contd. - Over Three Decades of Partnering in Public Health: USP-MHLW/PMDA Collaboration - Expectation from industry - Q&A |
15 min 10 min 15 min |
Dr. Kevin T Moore, USP Dr. Makoto Ono, FPMAJ |
|
10:45~11:30 11:30~11:50 |
(Science) Session 2: New Technologies and Modalities Moderator: Dr. Kenichi Izutsu, NIHS |
||
| (1) Continuous manufacturing - PMDA/JP Perspective on Continuous Manufacturing - Supporting Continuous Manufacturing: Ongoing USP Initiatives - Q&A (2) qNMR - Implementation of qNMR in the Japanese Pharmacopoeia |
20 min 20 min 5 min 20 min |
Dr. Yoshihiro Matsuda, PMDA Dr. Atul Dubey, USP Dr. Nahoko Uchiyama, NIHS |
|
| 11:50~12:50 | Lunch Break | ||
| 12:50~13:15 | Session 2 (2) contd. - Lifecycle Approach to Quantitative NMR Analytical Procedure - Q&A |
20 min 5 min |
Dr. Toru Miura, USP |
| 13:15~14:00 |
(3) Performance Testing - New performance tests for formulations in Japanese Pharmacopoeia - USP updates on Performance Tests - Q&A |
20 min 20 min 5 min |
Dr. Hiroyuki Yoshida, NIHS Dr. Margareth Marques, USP |
| 14:00~14:15 | Break | ||
| 14:15~15:45 | Session 3: Standards for Biologics Moderator: Dr. Akiko Ishii-Watabe, NIHS |
||
| - Current trends and future perspectives of JP standards for biologics - General Information: Bacterial Endotoxins Test and Alternative Methods using Recombinant Protein-reagents for Endotoxin Assay <G4-4-180> - Evolving USP Biologics Standards - Q&A |
20 min
20 min 40 min 10 min |
Dr. Akiko Ishii-Watabe, Dr. Hiroko Shibata, NIHS Dr. Yutaka Kikuchi, JP (Chiba Prefectural University of Health Sciences) Dr. Fouad Atouf, USP |
|
| 15:45~16:00 | Break | ||
| 16:00~17:30 |
Session 4: Impurities: Mutagenic impurities and more Moderator: Mr. Hiromu Toyoda, FPMAJ / Dr. Mrunal A. Jaywant, USP |
||
| - ICH M7: Situation at a Japanese Company - Current approach for control of nitrosamine impurities in Japan - Control of organic impurities in marketed products in Japan - current status and perspectives - Control of elemental impurities and current status in Japan - Control of nitrosamine impurities in sartan drugs - Q&A |
20 min 20 min 20 min 10 min 10 min 10 min |
Dr. Kazusei Komatsu, FPMAJ Mr. Yasuo Hirai, FPMAJ Dr. Junichi Fukuchi, PMDA Mr. Shunin Hikage, PMDA Dr. Masahiro Uchino, PMDA |
|
| 17:30~17:40 | Day 1 closing | ||
<Day 2: JST June 17>
| Time | Contents, Speakers | ||
|---|---|---|---|
| 8:30~8:40 | Day 2 opening | ||
| 8:40~9:30 | Session 4 contd. - Nitrosamine Impurities, USP’s Response -Tools & Resources - General Principles and Approach for Addressing Element-Specific Chapters and Tests in Excipient Monographs - Q&A |
20 min 20 min 10 min |
Mr. Naiffer E. Romero, USP Dr. Catherine Sheehan, USP |
| 9:30~10:30 | Panel Discussion for Session 2-4 Moderator: Mr. Kenichi Mikami, PMDA / Dr. Kevin T Moore, USP |
||
| 10:30~10:40 | Break | ||
10:40~11:50 |
(Keynotes) Key Note Session: Future Perspectives Moderator: Mr. Shigeki Tsuda, PMRJ |
||
| - USP’s Vision for the Advancement of Science Quality as a Framework for Pharmacopeial Collaboration. - Q&A for USP - JP’s Future Perspective on collaboration with USP - Q&A for PMDA/JP |
25 min 10 min 25 min 10 min |
Dr. Jaap Venema, USP Dr. Haruhiro Okuda, PMRJ |
|
| 11:50~12:00 | Closing Remarks | Mr. Masahiro Takahata, MHLW | |
Registration
Registration closed
For registration and inquiries, please contact the following website.
Registration website: https://j-pda.jp/archives/mhlw_usp_pmda20210616
Registration Fee: Free