This page contains PDF formatted slides, presented by PMDA members at meetings and seminars, before 2016.
Please click the following category.
- PMDA Policy presented by Chief Executive or Executives
- Regulatory Science
- International Programs
- New Drug
- Cellular and Tissue-based Products ・ Biologics
- OTC, Generic Drugs
- Medical Devices
- Compliance (GCP, GLP etc)
- GMP Inspection
- Safety
- Relief Funds
| Presentation Title | Presenter | Place | Date |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Presentation Title | Presenter | Place | Date |
|---|---|---|---|
| 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 |
| Presentation Title | Presenter | Place | Date |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Presentation Title | Presenter | Place | Date |
|---|---|---|---|
| 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 |
| 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 |