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Joint MHLW/PMDA-USP Workshop “Role of Quality in Pharmaceuticals”

 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

Draft 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 

Q&A

Dr. Ronald T Pievincenzi, USP

9:15~9:50
(Policy)
Session 1: Introduction of each Pharmacopeia
Moderator: Dr. Kevin T Moore, USP
- USP
- JP
- 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.
- PDG and USP-PMDA collaboration
- Expectation from industry
- Q&A

15 min
10 min
15 min

Dr. Kevin T Moore, USP
TBD (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

- USP
- Q&A
(2) qNMR
- PMDA/JP

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 3 (2) contd.
- USP
- Q&A

20 min
  5 min

Dr. Toru Miura, USP
13:15~14:00 (3) Performance Testing
- PMDA/JP

- USP

- 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
General Monographs, New testing for endotoxin
Moderator: Dr. Akiko Ishii-Watabe, NIHS
- PMDA/JP
  General Monographs and testing methods

  New testing for Endotoxin



- USP
- Q&A

40 min


 



40 min
10 min

Dr. Akiko Ishii-Watabe, NIHS
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
Nitrosamines, Mutagenic impurities, Elemental impurities (short)
Moderator: TBD (FPMAJ) / TBD (USP)
- Industry
- PMDA/JP





- Q&A
40 min
40 min





10 min
TBD (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.
- USP

- Q&A

40 min

10 min

Dr. Naiffer E. Romero, 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
- Q&A for USP
- PMDA/JP

- 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  TBD

 

Registration

For registration and inquiries, please contact the following website.
Registration website: https://j-pda.jp/archives/mhlw_usp_pmda20210616
Registration Fee: Free

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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