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
- Regulatory Science
- New Drug
- Cellular and Tissue-based Products ・ Biologics
- Medical Devices
- Compliance (GCP, GLP etc)
- Safety
- Patient and Public Involvement
Currently, there are no applicable information.
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| 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 |
| Presentation Title | Presenter | Place | Date |
|---|---|---|---|
| Data-driven identification of adverse event reporting patterns for Japan in VigiBase and follow-up analysis in JADER | Wakao R, Office of Reserch Promotion | WHO Drug User Group webcast - Japan、Tokyo, Japan | Dec 2020 |
| 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 |
| Presentation Title | Presenter | Place | Date |
|---|---|---|---|
| PMDA Update | Ando Y, Senior Scientist for Biostatistics | CDISC 2021 US Interchange, Virtual | Oct 2021 |
| PMDA/JP Perspective on Continuous Manufacturing | Matsuda Y, Senior Scientist for Quality | Joint MHLW/PMDA-USP Workshop、Tokyo, Japan (Web) | Jun 2021 |
| Update on ICH Q13 | Matsuda Y, Senior Scientist for Quality | ISPE Singapore Affiliate Conference and Exhibition 2020、Singapore（Web） | Dec 2020 |
| 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 |
| 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 |
| 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 |
| Presentation Title | Presenter | Place | Date |
|---|---|---|---|
| Control of organic impurities in marketed products in Japan - current status and perspectives | Fukuchi J, Office of Review Management | Joint MHLW/PMDA-USP Workshop、Tokyo, Japan (Web) | Jun 2021 |
| 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 |
| 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 |
| Presentation Title | Presenter | Place | Date |
|---|---|---|---|
| Promoting Patient and Public Involvement in Japan | Fujiwara Y, Chief Executive | DIA 32th Annual EuroMeeting, Virtual | Jun 2020 |