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Recent Presentation by PMDA Staffs

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.
 

PMDA Policy presented by Chief Executive or Executives

Presentation Title Presenter Place Date
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
New Regulation in Japan and Future Direction of PMDA Kondo T, Chief Executive DIA 2016 52nd Annual Meeting, Philadelphia,  USA Jun
2016
Strategic Approach to Post-Marketing Safety Measures Tawaragi T, Chief Management Officer DIA 2016 52nd Annual Meeting, Philadelphia,  USA Jun
2016
International Strategy and International Contribution of PMDA Tominaga T, Associate Executive Director (for International Programs) DIA 2016 52nd Annual Meeting, Philadelphia,  USA Jun
2016
Rolling Reviews in SAKIGAKE and Breakthrough Therapy Designation Tominaga T, Associate Executive Director (for International Programs) DIA 2016 52nd Annual Meeting, Philadelphia,  USA Jun
2016
PMDA Update New Regulation in Japan and Future Direction of PMDA Shigeto K, Executive Director 28th DIA Annual EuroMeeting, Hamburg, Germany Apr
2016
PMDA Update Science-based Initiatives of PMDA From “accelerated” to “advanced” review Yamori T, Director of Center for Product Evaluation 28th DIA Annual EuroMeeting, Hamburg, Germany Apr
2016
Strategic Approach to Post-Marketing Safety Measures Tawaragi T, Chief Safety Officer 28th DIA Annual EuroMeeting, Hamburg, Germany Apr
2016
ICMRA's Role in Capacity Building: Where are Gaps and Overlaps? Tominaga T, Associate Executive Director (for International Programs) 28th DIA Annual EuroMeeting, Hamburg, Germany Apr
2016
PMDA's Approaches to the Approval of Innovative Products Tominaga T, Associate Executive Director (for International Programs) 28th DIA Annual EuroMeeting, Hamburg, Germany Apr
2016
Asian Trends in Drug Development & Regulation Competition, collaboration and Harmonization Tominaga T, Associate Executive Director (for International Programs) 10th DIA Asia New Drug conference in Japan, Tokyo, Japan Apr
2016
New Regulation in Japan and Future Direction of PMDA Kondo T, Chief Executive 51st DIA Annual meeting, Washington DC, USA Jun
2015
Science-based Initiatives of PMDA Yamori T, Director of Center for Product Evaluation 51st DIA Annual meeting, Washington DC, USA Jun
2015
New Streams of Risk Management Tawaragi T, Chief Safety Officer 51st DIA Annual meeting, Washington DC, USA Jun
2015
Harmonization, Convergence, and ICH Reform Tominaga T, Associate Executive Director (for International Programs) 51st DIA Annual meeting, Washington DC, USA Jun
2015
New Regulation in Japan and Future Direction of PMDA Hojo T, Senior Executive Director 27th DIA Annual EuroMeeting, Paris, France Apr
2015
Science-based Initiatives of PMDA Nagano T, Executive Director 27th DIA Annual EuroMeeting, Paris, France Apr
2015
New Streams of Risk Management Tawaragi T, Chief Safety Officer 27th DIA Annual EuroMeeting, Paris, France Apr
2015
PMDA's Achievements and Future Perspectives (Summary) Kondo T, Chief Executive 50th DIA Annual meeting, San Diego, USA Jun
2014
PMDA's Efforts in Medicinal Area Nagano T, Executive Director 50th DIA Annual meeting, San Diego, USA Jun
2014
PMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals Yamori T, Director of Center for Product Evaluation and Deputy Director General of the Office of Review Innovation CMC Strategy Forum Europe 2014, Sorrento, Italy May
2014
Future Plan of PMDA for the Next Five Years Kondo T, Chief Executive 26th DIA Annual EuroMeeting, Vienna, Austria Mar
2014
PMDA's Efforts in Medical Area Yamori T, Director of Center for Product Evaluation and Deputy Director General of the Office of Review Innovation 26th DIA Annual EuroMeeting, Vienna, Austria Mar
2014
Future Drug Development and Regulatory Science Kondo T, Chief Executive 10th Annual Meeting DIA, Tokyo, Japan Nov
2013
PMDA's Efforts in Safety Measures - Risk Management Plan (RMP) in Japan - Mori K, Chief Safety Officer 49th DIA Annual Meeting, Boston, USA Jun
2013
PMDA Update: Its current situation and future direction Kondo T, Chief Executive 49th DIA Annual Meeting, Boston, USA Jun
2013
PMDA's Efforts in Medicinal Area Yamori T, Director of Center for Product Evaluation and Deputy Director General of the Office of Review Innovation 49th DIA Annual Meeting, Boston, USA Jun
2013
PMDA Update: Its current situation and future direction Kondo T, Chief Executive 25th DIA Annual EuroMeeting, amsterdam, Netherlands Mar
2013
PMDA's Efforts in Medicinal Area - Cultivate Human Resources & Science Board - Utsumi H, Executive Director 25th DIA Annual EuroMeeting, amsterdam, Netherlands Mar
2013
PMDA's Efforts in Safety Measures - Risk Management Plan (RMP) in Japan - Mori K, Chief Safety Officer 25th DIA Annual EuroMeeting, amsterdam, Netherlands Mar
2013
The Benefit/ Risk Balance During the Life Cycle of Drugs in Japan Kondo T, Chief Executive Swissmedic International Regulatory Symposium, Interlaken, Switzerland Sep
2012
PMDA Current Situation and Aim for the Future Kondo T, Chief Executive 48th Annual DIA meeting, Philadelphia, USA Jun
2012
PMDA's Efforts in Medical Innovation - Regulatory Science & Science Board - Utsumi H, Executive Director 48th Annual DIA meeting, Philadelphia, USA Jun
2012
PMDA Vision: Its Current Situation and Aim for the Future Kondo T, Chief Executive DIA 24th Annual EuroMeeting, Copenhagen, Denmark Mar
2012
The Future Prospects of PMDA Utsumi H, Executive Director International Symposium on Past, Present and Future of Molecular Pharmacokinetics, Tokyo, Japan Jan
2012
 

Regulatory Science

Presentation Title Presenter Place Date
PMDA Perspective: Utilization of the Disease Registry Data for Drug Development Hori A, Office of Regulatory Science 13th DIA Japan Annual Meeting 2016, Tokyo, Japan Nov
2016
Regulatory Science Research in PMDA Uyama Y, Office of Review Management 12th Kitasato-Harvard Symposium, Tokyo, Japan May
2013
Regulatory use of innovative tools in drug development Uyama Y, Office of Review Management 2013 Harvard University-Pharmaceutical Regulatory Science Symposium, Boston, USA May
2013
Regulatory Science Research in PMDA Uyama Y, Office of Regulatory Science 47th Annual DIA meeting, Chicago, USA Jun
2011


International Programs

Presentation Title Presenter Place Date
Progress of International Collaboration among Asian Countries Nakashima N, Office of International Programs 50th DIA Annual meeting, San Diego, USA Jun
2014
Global Pediatric Development: We Are Making Progress, PMDA Perspective Sato J, The Leader of Paediatric Working Group Director of Regulatory Cooperation, OIP 50th DIA Annual meeting,San Diego, USA Jun
2014
Difference between EU-RMP and JP-RMP-Those features perspective- Sato J, International Liaison Official 10th Annual Meeting DIA, Tokyo, Japan Nov
2013
Expectation for PBRER and its foresight - Insights from current situation both in EU and Japan Sato J, International Liaison Official 10th Annual Meeting DIA, Tokyo, Japan Nov
2013
International cooperation and consideration on Multi Regional Clinical Trial among Asia Uzu S, Office of New Drug I 25th DIA Annual EuroMeeting, amsterdam, Netherlands Mar
2013
Consideration on Global Harmonization Nakashima N, Office of International Programs International Conference of Drug Regulatory Authorities, Tallinn, Estonia Oct
2012
PMDA International Vision and Cooperation with Asian Drug Regulatory Authorities Tominaga T, Office of International Programs 6th Annual Conference in Japan for Asian New Drug Development, Tokyo, Japan Apr
2012
APEC MRCT Roadmap: Regulatory authorities' efforts to promote multi-regional clinical trials (MRCTs) Tominaga T, Office of International Programs DIA 24th Annual EuroMeeting, Copenhagen, Denmark Mar
2012
EU, USA and Japan (II) - Reports from Regulators on Exchange Assignments Hayashi Y, Office of International Programs DIA 24th Annual EuroMeeting, Copenhagen, Denmark Mar
2012


New Drug

Presentation Title Presenter Place Date
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
PMDA's perspective on regulatory science in pharmaceutical regulation Uyama Y, Office of Medical Informatics and Epidemiology The Copenhagen Centre for Regulatory Science (CORS), Copenhagen, Denmark Nov
2016
PMDA Perspective on Continuous Manufacturing Matsuda Y, Senior Scientist for Quality 13th DIA Japan Annual Meeting 2016, Tokyo, Japan Nov
2016
CMC Topics and PMDA's activities Matsuda Y, Senior Scientist for Quality
CMC Forums, Osong, Korea
Nov
2016
Continuous Manufacturing PMDA's Perspective Matsuda Y, Senior Scientist for Quality 2nd International Symposium on Continuous Manufacturing of Pharmaceuticals, Boston, USA Sep
2016
Example of QbD Application in Japan Matsuda Y, Senior Scientist for Quality 1st Conference of Strengthening ASEAN Pharmaceutical Regulatory on Quality, Bangkok, Thailand Aug
2016
PMDA Update Ando Y, Senior Scientist for Biostatistics 2016 CDISC Japan Interchange conference, Tokyo, Japan Jun
2016
Role of Pharmacometrics in Drug Development and Regulatory Review: PMDA Perspectives Nagai N, Principal Senior Scientist for Pharmacokinetics Center for Product Evaluation PMDA-Keio joint symposium on pharmacometrics, Tokyo, Japan Dec
2015
Fostering Further Collaboration between PMDA and Applicants with Efficient “Project Management” in Drug Development Sekino K, Office of New Drug I 12th Annual Meeting DIA Japan 2015, Tokyo, Japan Nov
2015
Overview of ICH E9(R1) Ando Y, Senior Scientist for Biostatistics 12th Annual Meeting DIA Japan 2015, Tokyo, Japan Nov
2015
CDISC Implementation in PMDA Ando Y, Senior Scientist for Biostatistics 2015 CDISC International Interchange, Chicago, USA Nov
2015
Current Status and Perspectives on Pharmaceutical Products in Japan Matsuda Y, Office of Standards and Guidelines Development KFDC Annual Meeting, Seoul, Korea Nov
2015
Model informed drug development: Japanese regulatory perspectives Nagai N, Principal Senior Scientist for Pharmacokinetics Center for Product Evaluation The American Conference on Pharmacometrics 2015 (ACoP6), Arlington, USA Oct
2015
Advanced Review with Electronic Data and CDISC Implementation in PMDA Ando Y, Senior Scientist for Biostatistics PhUSE Annual Conference 2015, Vienna, Austria Oct
2015
Ethnic factors, Consideration in Asian MRCT and Global Drug Development Strategies Uyama Y, Office of Medical Informatics and Epidemiology Asian Regional Drug Development Summit 2015, Shanghai, China Sep
2015
Biostatistical review of new drug applications in Japan -Current and future activity- Ando Y, Senior Scientist for Biostatistics ISBS-DIA Joint Symposium on Biopharmaceutical Statistics, Beijing, China Jul
2015
Technical Guide for Electronic Data Submission in Japan Ando Y, Senior Scientist for Biostatistics CDISC Japan Interchange 2015, Tokyo, Japan Jun
2015
Updates of MRCT in Japan Ando Y, Senior Scientist for Biostatistics 51st DIA Annual meeting, Washington DC, USA Jun
2015
Our Way to CDISC Submissions - An Update 12 Months Later Ando Y, Senior Scientist for Biostatistics CDISC Europe Interchange 2015, Basel, Switzerland May
2015
Regulatory perspective to review MRCT data for drug approval: Focusing on ethnic factor evaluation Uyama Y, Office of Medical Informatics and Epidemiology 27th DIA Annual EuroMeeting, Paris, France Apr
2015
Guidance on Data Monitoring Committee: Regulatory Perspective in Japan Ando Y, Senior Scientist for Biostatistics Austria-Japan Joint Statistics Workshop, Osaka, Japan Mar
2015
CDISC standards and data management-The essential elements for advanced Review with Electronic Data Ando Y, Senior Scientist for Biostatistics The 18th Annual Workshop in Japan for Clinical Data Management, Tokyo, Japan Jan
2015
Advancing Roles of Japan on Global Drug Development-Ethnic factors consideration with a view to international Harmonization- Uyama Y, Office of Safety I 11th Annual Meeting DIA, Tokyo, Japan Nov
2014
Introduction of Third 5-Year Mid-Term Plan of PMDA Hiraiwa M, Office of Planning and Coordination 50th DIA Annual meeting, San Diego, USA Jun
2014
Progress and Challenges to approve a drug based on data from global clinical trials: PMDA's experience Uyama Y, Office of Safety I 50th DIA Annual meeting, San Diego, USA Jun
2014
Overview of CDISC Implementation at PMDA Ando Y, Senior Scientist for Biostatistics CDISC Europe Interchange. Paris, France Apr
2014
Data standardization and advancing regulatory science Uyama Y, Office of Review Management 17th Annual Workshop in Japan for Clinical Data Management: BEYOND the Standardization, Tokyo, Japan Jan
2014
Japan PMDA and CDISC Standards Ando Y, Senior Scientist for Biostatistics CDISC International Interchange 2013, Bethesda, US Nov
2013
PMDA's experiences to review data of bridging study based on ICH E5 guideline. Uyama Y, Office of Review Management FIP SIG Regulatory Science Workshop, "Harmonization of Bridging Studies among Asia-Pacific Region, Taipei, Taiwan Nov
2013
New trend of clinical development in Japan; from sequential bridging to simultaneous global development Uyama Y, Office of Review Management FIP SIG Regulatory Science Workshop, "Harmonization of Bridging Studies among Asia-Pacific Region, Taipei, Taiwan Nov
2013
Regulatory and statistical issues of Multi-regional Clinical Trials: "Reference Cases" and current situation in Japan Ando Y, Senior Scientist for Biostatistics ICSA/ISBS, Bethesda, US Jun
2013
Principles and Case Examples in Global/Asian Clinical Trials Ando Y, Senior Scientist for Biostatistics 5th DIA China 2013 Annual Meeting, Beijing, China May
2013
PMDA's Perspectives in Global Clinical Data Evaluation for Drug Approval Uyama Y, Office of Review Management 7th Annual Conference in Japan for Asian New Drug Development, Tokyo, Japan Apr
2013
HEART FAILURE TRIALISTS WORKSHOP: Japanese Regulatory Viewpoint Ando Y, Senior Scientist for Biostatistics CVCT Forum 2012, Paris, France Dec
2012
Background and outline of "Basic Principles on Global Clinical Trials (Reference Cases)" Ando Y, Senior Scientist for Biostatistics 9th Annual Meeting DIA, Tokyo, Japan Nov
2012
Genomics in patients with Japanese Ancestry Uyama Y, Office of Review Management EMA Workshop on Pharmacogenomics: From science to clinical care, London, UK Oct
2012
Model Building Drug Development (MBDD) and Bridging in Asia - Japanese Regulatory Perspective Nagai N, Senior Scientist for Pharmacokinetics Center for Product Evaluation WCoP 2012, Seoul, Korea Sep
2012
Looking beyond ICH-E9 in the Era of Global Drug Development Ando Y, Senior Scientist for Biostatistics Biostatistics Summer Workshop 2012, Osaka Aug
2012
Design and Evaluation of Multiregional Clinical Trials: Experience in Japan Ando Y, Senior Scientist for Biostatistics 2012 Joint Statistical Meeting, San Diego, USA Aug
2012
Asian Ethnic Similarities and Differences: PMDA Point of View Uyama Y, Office of Regulatory Science 48th Annual DIA meeting, Philadelphia, USA Jun
2012
PMDA's Efforts to strengthen New Drug Review Yoda N, Office of New Drug III 4th DIA China Annual Meeting, Shanghai, China May
2012
Is Extrapolation of Foreign QT Data Required? - A Regulatory Perspective Ando Y, Senior Scientist for Biostatistics 3rd Cardiac Safety Workshop in Japan, Tokyo, Japan May
2012
Current Topics of Pharmaceutical Regulatory Affairs in Japan Sato T, Associate Center Director The 3rd China-Japan Symposium on Drug Development, Beijing, China Mar
2012
Current position and expectation for use of M&S in drug development and regulatory decision making - The PMDA Viewpoint Ando Y, Senior Scientist for Biostatistics EMA-EFPIA Modelling and Simulation Workshop, London, UK Nov
2011
Pre-consultation system at the authority for clinical trials and NDA in Japan Sato T, Associate Center Director The 6th Seminar Joint Taiwan and Japan, Taipei, Taiwan Nov
2011
Multi-Regional Clinical Trials in Global Drug Development: Update and Related Issues Ando Y, Senior Scientist for Biostatistics 2011 APEC MRCT Tokyo Workshop, Tokyo, Japan Nov
2011
This is How PMDA Achieved the NDA Review Cycle Time Target審査期間の短縮をどのように成し遂げたか Sato T, Centre for Product Evaluation 8th DIA Japan Annual Meeting, Tokyo, Japan Oct
2011
Comments on Adaptive Design Ando Y, Senior Scientist for Biostatistics 8th DIA Japan Annual Meeting, Tokyo, Japan Oct
2011
Extrapolation of the non - Japanese TQT data to Japanese NDAs Shinagawa K, Senior Scientist for Clinical Medicine 2nd Cardiac Safety Workshop in Japan, Tokyo, Japan Sep
2011
Acceptance of Clinical Data - The Challenge of Generalizability - Ando Y, Office of New Drug II Asia Regulatory Conference, Seoul, Korea Apr
2011
 

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
Rapid Microbiological Methods for Sterility Testing of Regenerative Medical Products in Japan Maruyama Y, Office of Cellular and Tissue-based Products ISCT 2016 Annual Meeting, Singapore, Singapore May
2016
Considerations for Screening/Transferring Cells for Further Manufacturing Maruyama Y, Office of Cellular and Tissue-based Products ISCT 2016 Annual Meeting, Singapore, Singapore May
2016
Specification and Process Control Maruyama Y, Office of Cellular and Tissue-based Products International Regulatory Forum of Human Cell Therapy and Gene therapy Products, Osaka, Japan Mar
2016
Perspectives on Trends in the Regulation of Biopharmaceutical Products in Europe and Asia(Japan) Sato D, Office of Cellular and Tissue-based Products WCBP 2016, Washington DC, USA Jan
2016
Updates on global movement in regulation of Advanced Therapeutics Sato D, Office of Cellular and Tissue-based Products Advanced Therapeutics Workshop CoRE, Singapore, Singapore Jan
2016
Clinical Evaluation of Advanced Therapeutics Maruyama Y, Sato D, Office of Cellular and Tissue-based Products Advanced Therapeutics Workshop CoRE, Singapore, Singapore Jan
2016
Quality Aspects of Regenerative Medical Products Maruyama Y, Office of Cellular and Tissue-based Products 12th Annual Meeting DIA Japan 2015, Tokyo, Japan Nov
2015
Regulatory Trends in Regenerative Medicine in Japan Sato D, Office of Cellular and Tissue-based Products Global Bio Conference 2015, Incheon, Korea Jun
2015
Marketing Authorizations for Earlier Patient Access: Regulatory Challenges in Japan Sato D, Office of Cellular and Tissue-based Products 51st DIA Annual meeting, Washington DC, USA Jun
2015
Cancer immunotherapy:
Regulatory implications in Japan
Sato D, Office of Cellular and Tissue-based Products Forum for Innovative Regenerative Medicine, Tokyo, Japan Feb
2015
Exposition of New Regulation in the Revision of Pharmaceutical Affairs Law - For Correct Understanding of “Conditional & Time Limited Approval” Sato D, Office of Cellular and Tissue-based Products 11th Annual Meeting DIA JAPAN 2014, Tokyo, Japan Nov
2014
ACTO Satellite symposium - Japanese regulation of regenerative medicine Sato D, Office of Cellular and Tissue-based Products The 5th meeting of  Asian Cellular Therapy Organization, Osaka, Japan Nov
2014
Regulatory Updates on Cellular and Tissue-based Products in Japan Maeda D, Office of Cellular and Tissue-based Products International Society for Cellular Therapy (ISCT), Paris, France Apr
2014
Regulatory Perspectives of Japan Kusakabe T, Office of Cellular and Tissue-based Products International Alliance for Biological Standardization (IABS), Kyoto, Japan Mar
2014
Regulatory Updates on Cellular Therapy Products in Japan Kusakabe T, Office of Cellular and Tissue-based Products International Society for Cellular Therapy (ISCT), Auckland, New Zealand Apr
2013
Recent Regulations of Biosimilars in Japan Arato T, Office of Biologics I 47th Annual DIA meeting, Chicago, USA Jun
2011
 

OTC, Generic Drugs

Presentation Title Presenter Place Date
Approval Review of Generic Drugs in Japan Osa Y & Saito K, Office of OTC/Generic Drugs Second International Generic Drug Regulators Meeting, Washington D.C., USA Apr
2012
 

Medical Devices

Presentation Title Presenter Place Date
Importance of putting a puzzle together for clinical evaluation Ho M, Office of Medical Devices I The 24th Annual Meeting of the Japanese Association of Cardiovascular Intervention and Therapeutics:(CVIT2015), Fukuoka, Japan Aug
2015
PMDA's effort to accelerate medical devices development-Introduction of PMDA's development support systems Hashimoto Y, Office of Medical Devices I The 24th Annual Meeting of the Japanese Association of Cardiovascular Intervention and Therapeutics:(CVIT2015), Fukuoka, Japan Aug
2015
Regulatory Assessment of New Bioresorbable Scaffolds: PMDA Point of View Ho M, Office of Medical Devices I The 24th Annual Meeting of the Japanese Association of Cardiovascular Intervention and Therapeutics:(CVIT2015), Fukuoka, Japan Jul
2015
Overview of US-Japan Pilot Program Regarding Collaborative Consultation and Review Ho M, Office of Medical Devices I HBD Think Tank East 2013, Tokyo, Japan Jul
2013
The Overview of PMDA Activities Tamura A, International Coordination Officer for Medical Devices 3rd China International Medical Device Regulatory Forum, Beijing, China Sep
2012
Regulatory Issues for PAD Devices Ikeda K, Office of Medical Devices I Transcatheter Cardiovascular Therapeutics (TCT) conference 2011, San Francisco, USA Nov
2011
Current status of orphan device development in Japan Suzuki Y, Office of Medical Devices II AdvaMed 2011: The MedTech Conference, Washington D.C., USA Sep
2011
Understanding Japanese Medical Device Requirements Tamura A, International Coordination Officer for Medical Devices 2011 AHC Workshop on Medical Devices: "Implementation of GHTF Documents", Seoul, Korea Jul
2011
Understanding Japanese Medical Device Requirements Japan's experimence to implement international guidance documents Tamura A, International Coordination Officer for Medical Devices 2011 AHC Workshop on Medical Devices: "Implementation of GHTF Documents", Seoul, Korea Jul
2011
 

Compliance (GCP, GLP etc)

Presentation Title Presenter Place Date
Addendum to ICH E6 Ui H, Office of Non-clinical and Clinical Compliance 2016 Conference on Good Clinical Practice, Taipei, Taiwan Jul
2016
Risk-based approach on GCP inspection Matsui K, Office of Conformity Audit 2014 APEC LSIF Joint Multi-Regional Clinical Trials and Good Clinical Practice Inspection Workshop, Qingdao, China May
2014
Training components for GCP inspectors in PMDA Tateishi T, Office of Conformity Audit 2014 APEC LSIF Joint Multi-Regional Clinical Trials and Good Clinical Practice Inspection Workshop, Qingdao, China May
2014
Current Status and Challenges of Bilateral/Multilateral Meetings Sato J, International Liaison Officer 26th DIA Annual EuroMeeting, Vienna, Austria Mar
2014
Quality of Clinical Trials -PMDA's Point of View- Osawa T, Office of Conformity Audit The 12th Kitasato University-Harvard School of Public Health Symposium
Advanced and Global Drug Development Techniques: Next Steps and Actions as one of the Leading Countries, Tokyo, Japan
May
2013
Clinical Operation and Quality Assurance
- From PMDA's Point of View -
Kondo E, Office of Conformity Audit The 1st DIA Clinical Operation and Monitoring Workshop, Tokyo, Japan Jan
2013
The PMDA's GCP Inspection Methods, the Current State of Overseas GCP on-site inspections by PMDA Kondo E, Office of Conformity Audit The 3rd China-Japan Symposium on Drug Development, Beijing, China Mar
2012
The role of conformity audits of GCP inspections in Japanese authority and the quality of clinical trials in Japan. Anahara R et al., Office of Conformity Audit The Society of Toxicology 51st Annual Meeting, San Francisco, USA Mar
2012
Data Quality - from Inspectors' Point of View - Osawa T, Office of Conformity Audit 15th Annual Workshop in Japan for Clinical Data Management, Tokyo, Japan Jan
2012
Japanese National GLP Monitoring Programme on Medical Products Sato Y, Office of Conformity Audit 3rd Global Quality Assurance Conference, Kyoto, Japan Nov
2011
What we can do to ensure the quality Osawa T, Office of Conformity Audit Workshop on Quality Risk Management: Making Clinical Trials Fit for Purpose, Washington D.C., USA Aug
2011
 

GMP Inspection

Presentation Title Presenter Place Date
Examples of Observations in PMDA GMP Compliance Inspections (Korea) Fujino R, Office of GMP/QMS Inspection CPhI Japan 2014, Tokyo, Japan Apr
2014
Examples of Observations in GMP Compliance Inspections, and Related Problems (Manufacturer / Market Authorization Holder / In-country Caretaker of MF, etc.) (Chinese) Morisue M, Office of GMP/QMS Inspection CPhI China 2013, Shanghai, China Jun
2013
PMDA GMP Inspection Morisue M, Office of GMP/QMS Inspection 2nd India - Japan Pharmaceutical Seminar, Osaka, Japan Apr
2013
Examples of Observations in PMDA GMP Compliance Inspections (Chinese) Morisue M, Office of GMP/QMS Inspection CPhI China 2012, Shanghai, China Jun
2012
Preparation for PIC/S accession Challenges and Prospects Sakurai S, Office of GMP/QMS Inspection ISPE Japan Affliate 
2012 Annual Meeting 10th Anniversary Annual Meeting, Hiroshima, Japan
Apr
2012
Current Situation and Updates of QMS Inspection in Japan Makino T, Office of GMP/QMS Inspection RAPS 2011 The Regulatory Convergence, Indianapolis, USA Oct
2011
Medical device QMS/GMP system and audit Ishibashi K, Office of GMP/QMS Inspection 2011 AHC Workshop on Medical Devices: "Implementation of GHTF Documents", Seoul, Korea Jul
2011
 

Safety

Presentation Title Presenter Place Date
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
Risk of asthma attacks is increased in association with non-steroidal anti-inflammatory drugs adjusting for season effects Ando T, Takeuchi Y, Ishiguro C, Uyama Y, Office of Medical Informatics and Epidemiology DIA 2016 52nd Annual Meeting, Philadelphia,  USA Jun
2016
The Future Direction of Japan Regarding Benefit-risk balance Assessment Hori A, Office of Safety II 11th Annual Meeting DIA JAPAN 2014, Tokyo, Japan Nov
2014
Drug Use Study of Heparin using Japanese Claim Data of Inpatients Noguchi M, Endo A, Yamada K, Matsui K, Watanabe S, Office of Safety I 30th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Taipei, Taiwan Oct
2014
MIHARI Project Year 5 Medical Information for Risk Assessment Initiative Ishiguro C, Endo A, Matsui K, Watanabe S, Office of Safety I 30th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Taipei, Taiwan Oct
2014
The Risk of Acute Asthmatic Attacks Associated with Different Dosage Forms of Non-Steroidal Anti-Inflammatory Drugs: a Self-Controlled Case Series Study Takeuchi Y, Higa S, Endo A, Yamada K, Matsui K, Watanabe S, Office of Safety I 30th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Taipei, Taiwan Oct
2014
Safety Measures of PMDA - Risk Management Plan in Japan Yamamoto H, Chief Safety Officer 50th DIA Annual meeting, San Diego, USA Jun
2014
Safety Measures of PMDA - Risk Management Plan in Japan Yamamoto H, Chief Safety Officer 26th DIA Annual EuroMeeting, Vienna, Austria Mar
2014
Current Challenges of Regulation in Japan - Amendment of Pharmaceutical Affairs Act Yamamoto H, Chief Safety Officer 26th DIA Annual EuroMeeting, Vienna, Austria Mar
2014
Direct Patient ADR reporting system in Japan Mori K, Chief Safety Officer 48th Annual DIA meeting, Philadelphia, USA Jun
2012
Pharmacovigilance in Japan and Risk Management Plans (RMP); Regulator Perspective Mori K, Chief Safety Officer 48th Annual DIA meeting, Philadelphia, USA Jun
2012
PMDA's Recent Developments in Enhancement of Drug Safety Measures Ikeda M, Office of Safety I DIA 24th Annual EuroMeeting, Copenhagen, Denmark Mar
2012
Pharmacovigilance Activities in Japan Hori A, Office of Safety II WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden May
2011
 

Relief Funds

Presentation Title Presenter Place Date
Relief System for Adverse Drug Reactions
- Brief history and outline of the Relief System -
Onda Y, Office of Relief Funds 2015 KIDS Symposium, Seoul, Korea Nov
2015
Relief System for Sufferers from Adverse Drug Reactions
- Medical/pharmaceutical judgment -
Oniyama Y, Office of Relief Funds 2015 KIDS Symposium, Seoul, Korea Nov
2015
Relief Service for Adverse Health Effects in Japan Miyazaki S, Office of Relief Funds PMDA training seminar, Tokyo, Japan Nov
2010

 

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