MATSUDA YOSHIHIRO

J-GLOBAL         Last updated: Sep 9, 2019 at 17:16
 
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Name
MATSUDA YOSHIHIRO
Affiliation
PMDA
Job title
Senior Scientist (for Quality)
Degree
Ph.D.

Research Interests

 
 

Research Areas

 
 

Education

 
 
 - 
2003
Tokyo Medical and Dental University
 
 
 - 
1999
Graduate School, Division of Pharmaceutical Sciences, Toyama Medical and Pharmaceutical University
 
 
 - 
1997
Faculty of Pharmaceutical Science, Toho University
 

Committee Memberships

 
Feb 2015
 - 
Dec 2018
PDA Japan Chapter  representative
 

Published Papers

 
Global Regulatory Landscape
MATSUDA YOSHIHIRO
AAPS PharmSciTech   20(1)    Dec 2018   [Refereed][Invited]
Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice
Moheb M. Nasr, Markus Krumme, Yoshihiro Matsuda, Bernhardt L. Trout, Clive Badman, Salvatore Mascia, Charles L. Cooney, Keith D. Jensen, Alastair Florence, Craig Johnston, Konstantin Konstantinov, Sau L. Lee
Journal of Pharmaceutical Sciences   106(11) 3199-3206   Jun 2017   [Refereed]
MATSUDA YOSHIHIRO
Regulatory Science of Medical Products   7(2) 99-103   May 2017   [Refereed][Invited]
Major revised points of the 17th Edition of Japanese Pharmacopoeia
MATSUDA YOSHIHIRO
PHARM TECH JAPAN   31(8) 23-28   May 2015   [Invited]
Kumiko Sakai-Kato, Nobuhiro Nishiyama, Masato Kozaki, Takeshi Nakanishi, Yoshihiro Matsuda, Mai Hirano, Hiroyuki Haneda, Shigeru Hisada, Hiroshi Onodera, Hideyoshi Harashima, Yasuhiro Matsumura, Kazunori Kataoka, Yukihiro Goda, Haruhiro Okuda, Toru Kawanishi
Journal of Controlled Release   210 76-83   2015   [Refereed]
Evaluation of Block Copolymer Micelle Medicinal Products
Kumiko SAKAI-KATO, Takeshi NAKANISHI, Masato KOZAKI, Yoshihiro MATSUDA, Mai HIRANO, Hiroyuki HANADA, Shigeru HISADA, Hieoahi ONODERA, Nobuhiro NISHIYAMA, Hideyoshi HARASHIMA, Yasuhiro MATSUMURA, Kazunori KATAOKA, Haruhiro OKUDA, Toru KAWANISHI
PMDRS   44(12) 968-975   2013   [Invited]
Review and GMP inspection for New Drug Applications based on Quality by Design -Present situation and Challenges-
MATSUDA YOSHIHIRO, MORISUE MASATOSHI
PHARM TECH JAPAN   29(6) 61-68   May 2013   [Invited]
The PMDA Initiative for QbD Applications
MATSUDA YOSHIHIRO
Pharmaceutical and Medical Device Regulatory Science   43(7) 593-599   Jul 2012   [Invited]
Q-IWG
MATSUDA YOSHIHIRO
Pharmaceutical and Medical Device Regulatory Science   42(10) 897-899   2011   [Invited]

Misc

 
Effects of Shicimotsu-koka-to on learning deficit and neuronal degeneration induced by permanent occlusion of bilateral common carotid arteries in rats
Journal of Traditional Medicines   15(5) 330-331   1998
Proceedings of the National Academy of Sciences of the United States of America   97(11) 6132-6137   2000
Biochem. Biophys. Res. Commun.   289(4) 791-795   2001

Books etc

 
Current development in ICH Q13
MATSUDA YOSHIHIRO
PHARM TECH JAPAN   Mar 2019   

Conference Activities & Talks

 
ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products –Heading towards implementation- [Invited]
MATSUDA YOSHIHIRO
The 21st INTERPHEX Japan   4 Jul 2019   
PMDA Perspective [Invited]
MATSUDA YOSHIHIRO
The 4th FDA/PQRI Conference on Advancing Products Quality   10 Apr 2019   
The Challenge to the Continuous Manufacturing in Japan- from the Perspective of Regulators - [Invited]
MATSUDA YOSHIHIRO
Consortium on Continuous Pharmaceutical Manufacturing, Japan (CCPMJ) - 1st Seminar   13 Dec 2018   
Continuous Manufacturing [Invited]
MATSUDA YOSHIHIRO
25th PDA Japan Annual Meeting 2018   27 Nov 2018   
PMDA Update [Invited]
MATSUDA YOSHIHIRO
3rd International Symposium on Continuous Manufacturing of Pharmaceuticals   4 Oct 2018   
PMDA Activities for Implementation of Continuous Manufacturing [Invited]
MATSUDA YOSHIHIRO
ISPE Continuous Manufacturing Workshop   7 Jun 2018   
Global Regulatory Forum [Invited]
MATSUDA YOSHIHIRO
ISPE Quality Manufacturing Conference   6 Jun 2018   
The landscape of continuous manufacturing in Japan [Invited]
MATSUDA YOSHIHIRO
2018 ISPE Japan Affiliate Annual Meeting   24 May 2018   
CM Research Outcomes - Control Strategy, Batch Definition, Process Validation and Stability Testing [Invited]
MATSUDA YOSHIHIRO
IFPAC 2018   13 Feb 2018   
PMDA’s Perspectives on Continuous Manufacturing [Invited]
MATSUDA YOSHIHIRO
ISPE Japan Affiliate 2017 Annual Meeting   19 May 2017   
PMDA Update [Invited]
MATSUDA YOSHIHIRO
DIA CMC Workshop   24 Apr 2017   
Reducing the Complexity of Variation Management to Enable Timely Access of Medicinal Products [Invited]
MATSUDA YOSHIHIRO
The 9th Asia Regulatory Conference   7 Apr 2017   
PMDA’s Perspectives on Continuous Manufacturing [Invited]
MATSUDA YOSHIHIRO
3rd PQRI/FDA Conference on Advancing Product Quality   24 Mar 2017   
PMDA Perspective on Continuous Manufacturing [Invited]
MATSUDA YOSHIHIRO
13th DIA JAPAN Annual Meeting 2016   14 Nov 2016   
CMC Topics and PMDA’s activities [Invited]
MATSUDA YOSHIHIRO
International CMC Expert Invitational Forum   11 Nov 2016   
A New Paradigmshift of Japanese Pharmacopoeia [Invited]
MATSUDA YOSHIHIRO
Regulatory Science Expert Training Seminar   8 Nov 2016   
Continuous Manufacturing PMDA’s Perspective [Invited]
MATSUDA YOSHIHIRO
2nd International Symposium on Continuous Manufacturing of Pharmaceuticals   27 Sep 2016   
Example of QbD Application in Japan [Invited]
MATSUDA YOSHIHIRO
1st Conference of Strengthening ASEAN Pharmaceutical Regulatory on Quality   11 Aug 2016   
PMDA Perspective and Initiatives for Pharmaceutical Globalization
MATSUDA YOSHIHIRO
2016 Annual Meeting (Japan Affiliate)   15 Apr 2016   
Quality (CMC) [Invited]
MATSUDA YOSHIHIRO
Thai FDA-PMDA Training on Generics Track   25 Mar 2016   
A change and present situation of QbD applications [Invited]
MATSUDA YOSHIHIRO
The 18th Pharmaceutical Quality Forum   3 Feb 2016   
Perspective on Continuous Manufacturing [Invited]
MATSUDA YOSHIHIRO
ISPE Japan 2015 Winter Meeting   4 Dec 2015   
Current Status and Perspectives on Pharmaceutical Products in Japan [Invited]
MATSUDA YOSHIHIRO
The 2015 KFDC Annual Meeting   13 Nov 2015   
A New Paradigmshift of Japanese Pharmacopoeia [Invited]
MATSUDA YOSHIHIRO
Regulatory Science Expert Training Seminar   9 Nov 2015   
The 17th Japanese Pharmacopoeia and Residual Solvents [Invited]
MATSUDA YOSHIHIRO
The 175th Regulatory Science Expert Training Seminar   27 Aug 2015   
Panel Discussion [Invited]
MATSUDA YOSHIHIRO
4th DIA CMC Forum in Japan   2 Jul 2015   
CMC Challenges in Japan [Invited]
MATSUDA YOSHIHIRO
DIA CMC Workshop 2015   15 Apr 2015   
PMDA Perspective on Regulatory Commitments [Invited]
MATSUDA YOSHIHIRO
2014 AAPS Annual Meeting and Exposition   4 Nov 2014   
Current Status and Perspectives of QbD implementation [Invited]
MATSUDA YOSHIHIRO
KFDC Annual Meeting   30 Oct 2014   
Future ICH Topics; Informal Quality Discussion Group
MATSUDA YOSHIHIRO
10 Jul 2014   
Update from the FDA-EMA Parallel Assessment Pilot ; PMDA Perspective
MATSUDA YOSHIHIRO
DIA 2014 50th Annual Meeting   18 Jun 2014   
Experience in Japan - PMDA Perspectives-
MATSUDA YOSHIHIRO
ICH Quality Strategy Workshop   1 Jun 2014   
QbD Approach and Regulatory Challenges in Japan [Invited]
MATSUDA YOSHIHIRO
DIA EuroMeeting   27 Mar 2014   
PMDA Perspectives [Invited]
MATSUDA YOSHIHIRO
Joint Regulators/Industry QbD Workshop   29 Jan 2014   
Level of Documentation in Enhanced (QbD) Regulatory Submissions [Invited]
MATSUDA YOSHIHIRO
Workshop on Q8/Q9/Q10 Points to Consider   15 Feb 2013   
The Gap Between the Concept of Minor/Partial Changes in the Application Form and the Actual Operations
MATSUDA YOSHIHIRO
9th DIA Annual Meeting   20 Nov 2012   
Quality Brainstorming [Invited]
MATSUDA YOSHIHIRO
ICH Japan symposium2012   Jul 2012   
The current state of QbD applications in Japan [Invited]
MATSUDA YOSHIHIRO
ISPE Japan Affiliate 2012 Annual Meeting   Apr 2012   
Panel discussion [Invited]
MATSUDA YOSHIHIRO
Official Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10   Oct 2011   
A regulatory perspective on ICH Q8, Q9 and Q10 in Japan [Invited]
MATSUDA YOSHIHIRO
Proceedings of 2011 KFDC Annual Meeting   Oct 2011   
Panel discussion [Invited]
MATSUDA YOSHIHIRO
Aug 2011   
Regulatory Perspectives on Quality by Design
IUPAC International Congress on Analytical Sciences 2011   2011   
Regulatory Assessment
Integrated Implementation Training Workshops for ICH Q8,Q9,Q10 Follow Up   2011   
Case Study - Regulatory Assessment
Integrated Implementation Training Workshops for ICH Q8,Q9,Q10   2010   
ICH Q-trio - Approach in Japan and Future Issues
ISPE Japan Annual Meeting   2010   
Experience in implementing ICH Guidelines Q1-Q7
Workshop on Implementation of ICH Q8/Q9/Q10 and Other Quality Guidelines   2008   

Works

 
ICH Informal Quality Discussion Group
MATSUDA YOSHIHIRO   The Others   2013 - 2014
International Pharmaceutical Regulators Forum Nanomedicines Working Group
MATSUDA YOSHIHIRO   The Others   2015 - 2017
ICH Q13 Regulatory Chair
MATSUDA YOSHIHIRO   The Others   2018 - Today
ICH Q9 EWG expert
2003 - 2005
ICH Q10 EWG expert
2005

Research Grants & Projects

 
Study on Quality Assurance of Pharmaceutical Continuous Manufacturing
Japan Agency for Medical Research and Development: Research on Regulatory Science of Pharmaceuticals and Medical Devices
Project Year: Apr 2018 - Mar 2021    Investigator(s): MATSUDA YOSHIHIRO
Research on Pharmaceutical Quality Assurance by Continuous Manufacturing
The Japan Agency for Medical Research and Development (AMED): Research on Regulatory Science of Pharmaceuticals and Medical Devices
Project Year: Aug 2016 - Mar 2018    Investigator(s): MATSUDA YOSHIHIRO