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Events and Symposia

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

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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 June 16 - 17, 2021 (EST June. 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


8:30 to 8:40: Opening Remarks Dr. Hiroyuki Arai, PMDA
8:40 to 9:15 Opening Session : Role of Pharmacopeia in the Pandemic Era

8:40 to 9:05
  • Medicines quality throughout the COVID-19 pandemic: Collaboration and Trust”
    Dr. Ronald T Piervincenzi, USP

9:05 to 9:15
  • Q&A
9:15 to 10:45 (Policy) Session 1: Introduction of each Pharmacopeia
Moderator: Dr. Kevin T Moore, USP

9:15 to 9:50
9:50 to 10:05 Break


10:05 to 10:45 Session 1 contd.
  • Over Three Decades of Partnering in Public Health: USP-MHLW/PMDA Collaboration（15min）
    Dr. Kevin T Moore, USP
  • Expectation from industry (10min)
    Dr. Makoto Ono, FPMAJ
  • Q&A (15min)
10:45 to 14:00 (Science) Session 2: New Technologies and Modalities
Moderator: Dr. Kenichi Izutsu, NIHS

10:45 to 11:30 (1) Continuous manufacturing
11:30 to 11:50 (2) qNMR
11:50 to 12:50 Lunch Break


12:50 to 13:15 Session 2 (2) contd.
  • Lifecycle Approach to Quantitative NMR Analytical Procedure (20min)
    Dr. Toru Miura, USP
  • Q&A (5min)

13:15 to 14:00 (3) Performance Testing
14:00 to 14:15 Break
14:15 to 15:45 Session 3: Standards for Biologics
Moderator: Dr. Akiko Ishii-Watabe, NIHS
 
16:00 to 17:30 Session 4: Impurities: Mutagenic impurities and more
Moderator: Mr. Hiromu Toyoda, FPMAJ / Dr. Mrunal A. Jaywant, USP
 
17:30 to 17:40 Day 1 closing

Day 2: JST June 17

8:30 to 8:40 Day 2 opening

8:40 to 9:30 Session 4 contd.
  • Nitrosamine Impurities, USP’s Response - Tools & Resources (20min)
    Mr. Naiffer E. Romero, USP
  • General Principles and Approach for Addressing Element-Specific Chapters and Tests in Excipient Monographs (20min)
    Dr. Catherine Sheehan, USP
  • Q&A (10min)

9:30 to 10:30 Panel Discussion for Session 2-4
Moderator: Mr. Kenichi Mikami, PMDA / Dr. Kevin T Moore, USP

10:30 to 10:40 Break
10:40 to 11:50 (Keynotes) Key Note Session: Future Perspectives
Moderator: Mr. Shigeki Tsuda, PMRJ
 

11:50 to 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