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Recent Presentation by PMDA Staffs

Lecture materials created by PMDA staff, before 2016.
Please note that these presentation files reflect the presenters' views at the time of their presentation. PMDA is not in the position of answering questions on the content of the files. Also please refrain from contacting the presenter regarding the contents of their presentations.

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PMDA Policy presented by Chief Executive or Executives

Presentation Title Presenter Place Date
Recent Progress of PMDA - Timely Response to COVID-19 Pandemic - Fujiwara Y, Chief Executive DIA 2020 56th Annual Meeting, Virtual Jun 2020
Further Advancement for Early Patient Access Arai H, Executive Director and Director of Center for Product Evaluation DIA 2020 56th Annual Meeting, Virtual Jun 2020
The Future of PMDA Fujiwara Y, Chief Executive DIA 2019 55th Annual Meeting, San Diego,  USA Jun 2019
PMDA Center for Regulatory Science Arai H, Director of Center for Regulatory Science and Director of Center for Product Evaluation DIA 2019 55th Annual Meeting, San Diego,  USA Jun 2019
PMDA’s Regulatory Science and Innovation Kondo T, Chief Executive DIA 31th Annual EuroMeeting, Vienna, Austria Mar 2019
Regulatory Updates - Facilitating Early Patient Access - Mikami K, Director, Office of Review Management DIA 31th Annual EuroMeeting, Vienna, Austria Mar 2019
Real World Data Utilization: PMDA’s Approach to Pre-market Review and Pharmacovigilance Sato D, Chief Management Officer and Associate Centre Director for Regulatory Science DIA 31th Annual EuroMeeting, Vienna, Austria Mar 2019
PMDA’s Future Activities Kondo T, Chief Executive DIA 2017 53rd Annual Meeting, Chicago,  USA Jun 2017
PMDA Update for Post-market Safety and Quality Management UZU S, Chief Safety Officer DIA 2017 53rd Annual Meeting, Chicago,  USA Jun 2017
Regulatory Scientific Significance of Japan’s ADR Relief System Tominaga T, Associate Executive Director DIA 2017 53rd Annual Meeting, Chicago,  USA Jun 2017
Regulatory Perspective on ICH Tominaga T, Associate Executive Director DIA 2017 53rd Annual Meeting, Chicago,  USA Jun 2017
PMDA’s Efforts - Regulation and Innovation Yamori T, Executive Director DIA 29th Annual EuroMeeting, Glasgow, UK Mar 2017
PMDA update for post-Market Safety and Quality Management UZU S, Chief Safety Officer DIA 29th Annual EuroMeeting, Glasgow, UK Mar 2017

 

Regulatory Science

Presentation Title Presenter Place Date
Regulator’s Utilisation of Big Data in Pharmacovigilance Activities Kajiyama K, Office of Medical Informatics and Epidemiology DIA Europe 2018, Basel, Switzerland Apr 2018
CM Research Outcomes Matsuda Y, Senior Scientist for Quality IFPAC Annual Meeting, Bethesda, USA Feb 2018

 

New Drug

Presentation Title Presenter Place Date
A Bayesian model averaging approach for basket trials Asano J, Hirakawa A The 3rd Pacific Rim Cancer Biostatistics Conference, Portland, USA Jun 2019
PMDA Perspective Matsuda Y, Senior Scientist for Quality 4th FDA/PQRI Conference on Advancing Product Quality, Rockville, USA Apr 2019
PMDA Update Matsuda Y, Senior Scientist for Quality 3rd International Symposium on Continuous Manufacturing of Pharmaceuticals, London, UK Oct 2018
An evaluation and modification of Simon's basket design in oncology Asano J, Office of New Drug IV, Hirakawa A, The University of Tokyo ISCB Conference 2018, Melbourne, Australia Aug 2018
Regulator's Perspective on Precision Medicine Shinagawa K, Senior Scientist for Clinical Medicine 2018 CVCT Asia Forum,  Singapore, Singapore Jul 2018
Regulatory issues for academic-led multinational trials in Asia: Who takes responsibility? Shinagawa K, Senior Scientist for Clinical Medicine 2018 CVCT Asia Forum,  Singapore, Singapore Jul 2018
PMDA Activities for Implementation of Continuous Manufacturing Matsuda Y, Senior Scientist for Quality 2018 ISPE Continuous Manufacturing Workshop, Arlington, USA Jun 2018
Impact of MRCT after ICH E17 fully implement –Regulatory perspective– Kamada S, Office of New Drug V 5th Joint Conference of Taiwan and Japan on Medical Products Regulation, taipei, Taiwan Dec 2017
Mitigation of Risk and Selection of Clinical Starting Dose: A PMDA Nonclinical Perspective Matsumoto M, Office of New Drug II American College of Toxicology 38th Annual Meeting, Palm Springs, USA Nov 2017
PMDA's Experiences with New Drug Applications including Data from Multi Regional (Asian) Clinical Trials Otsubo Y, Office of New Drug V 14th DIA Japan Annual meeting 2017, Tokyo, Japan Nov 2017
Pediatric Drug Development in Japan and International Regulatory Collaboration Hirata M, Office of Cellular and Tissue-based Products 14th DIA Japan Annual meeting 2017, Tokyo, Japan Nov 2017
Assessment of QT Prolongation Risk Using Concentration Response Modeling - the Clinical Perspective- Shinagawa K, Senior Scientist for Clinical Medicine 14th DIA Japan Annual meeting 2017, Tokyo, Japan Nov 2017
PMDA’s Perspectives on Continuous Manufacturing Matsuda Y, Senior Scientist for Quality 2017 Annual Meeting 15th Anniversary ISPE Japan Affiliate, Toyama, Japan Mar 2017
PMDA Update Matsuda Y, Senior Scientist for Quality DIA CMC Workshop 2017, Rockville,  USA Apr 2017
PMDA’s Perspectives on Continuous Manufacturing Matsuda Y, Senior Scientist for Quality The 3rd FDA/PQRI Conference on Advancing Products Quality, Rockville,  USA Mar 2017

 

Cellular and Tissue-based Products ・ Biologics

Presentation Title Presenter Place Date
Accelerated CMC Development of Regenerative Medical Products Maruyama Y, Office of Cellular and Tissue-based Products CMC Strategy Forum Summer 2017, Washington DC, USA Jul 2017
Regulation of Regenerative Medicine in Japan Maruyama Y, Office of Cellular and Tissue-based Products Health Products Regulatory Conference 2017, Singapore, Singapore May 2017
Regulatory Trends  - Regenerative Medicine in Japan Sakushima K, Office of Cellular and Tissue-based Products ASENT 19th Annual Meeting, Rockville, USA Mar 2017

 

Medical Devices

Presentation Title Presenter Place Date
PMDA’s  Activities for Regulatory Utilization of Real World Data  – Introduction of New Consulting Category - Tomita N, Office of Standards and Compliance for Medical Devices 2019 Real World Data Study Workshop、Tianjin, China 2019

 

Compliance (GCP, GLP etc)

Presentation Title Presenter Place Date
Current Regulatory Considerations for Continuous Manufacturing of Pharmaceuticals in Japan Takayama I, Office of New Drug IV, Matsuda Y, Senior Scientist for Quality, Katori N, Division of Drugs, National Institute of Health Sciences 2018 PDA Annual Meeting,
Orlando, USA
Mar 2018
The recent progress of GCP inspection in Japan Komuro Y, Office of Non-clinical and Clinical Compliance 2017 Asia QA Forum Third International Conference, Beijing, China Sep 2017

 

Safety

Presentation Title Presenter Place Date
PMDA’s initiative on real world data utilization for regulatory purposes Uyama Y, Office of Medical Informatics and Epidemiology ACPE2019, Kyoto, Japan Oct 2019
Data-driven identification of adverse event reporting patterns for Japan in the WHO global database Wakao R, Office of Reserch Promotion, Iwasa E,  Office of Pharmacovigilance I, Taavola H, Sandberg L, Chandler R, Norén GN(Uppsala Monitoring Centre) 35th Conference on Pharmacoepidemiology and Therapeutic Risk Management (2019 ICPE), Philadelphia, USA Aug 2019
Japanese guidance and PMDA’s experiences in utilizing real world data for drug safety assessment Uyama Y, Office of Medical Informatics and Epidemiology 10th DIA China Annual Meeting, Beijing, China May 2018
Epidemiological review for pharmacovigilance planning in new drug application Ishiguro C, Office of Medical Informatics and Epidemiology 14th DIA Japan Annual meeting 2017, Tokyo, Japan Nov 2017
Post-market drug safety measures in Japan-Regulatory Experiences on Utilization of Electronic Medical Records- Uyama Y, Office of Medical Informatics and Epidemiology APEC AHC Pharmacovigilance Workshop, Seoul, Korea Sep 2017
Drug Safety Assessment in the Era of ICT Advancement Uyama Y, Office of Medical Informatics and Epidemiology 20th DIA Annual Workshop in Japan for Clinical Data Management, Tokyo, Japan Feb 2017

 

Patient and Public Involvement

Presentation Title Presenter Place Date
Promoting Patient and Public Involvement in Japan Fujiwara Y, Chief Executive DIA 32th Annual EuroMeeting, Virtual Jun 2020

 

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Recent Presentation by PMDA Staffs
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