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Past Presentations

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.

Topics Presentation Title Presenter Place Date
PMDA Policy

presented by Chief Executive or Executives
PDF形式PMDA's Efforts in Safety Measures - Risk Management Plan (RMP) in Japan - (PDF) Mr Mori K, Chief Safety Officer 49th DIA Annual Meeting, Boston, USA Jun 2013
PDF形式PMDA Update: Its current situation and future direction (PDF) Dr Kondo T, Chief Executive 49th DIA Annual Meeting, Boston, USA Jun 2013
PDF形式PMDA's Efforts in Medicinal Area (PDF) Dr Yamori T, Director of Center for Product Evaluation 49th DIA Annual Meeting, Boston, USA Jun 2013
PDF形式PMDA Update: Its current situation and future direction (PDF) Dr Kondo T, Chief Executive 25th DIA Annual EuroMeeting, amsterdam, Netherlands Mar 2013
PDF形式PMDA's Efforts in Medicinal Area - Cultivate Human Resources & Science Board - (PDF) Dr Utsumi H, Executive Director 25th DIA Annual EuroMeeting, amsterdam, Netherlands Mar 2013
PDF形式PMDA's Efforts in Safety Measures - Risk Management Plan (RMP) in Japan - (PDF) Mr Mori K, Chief Safety Officer 25th DIA Annual EuroMeeting, amsterdam, Netherlands Mar 2013
PDF形式The Benefit/ Risk Balance During the Life Cycle of Drugs in Japan (PDF) Dr Kondo T, Chief Executive Swissmedic International Regulatory Symposium, Interlaken, Switzerland Sep 2012
PDF形式PMDA Current Situation and Aim for the Future (PDF) Dr Kondo T, Chief Executive 48th Annual DIA meeting, Philadelphia, USA Jun 2012
PDF形式PMDA's Efforts in Medical Innovation - Regulatory Science & Science Board - (PDF) Dr Utsumi H, Executive Director 48th Annual DIA meeting, Philadelphia, USA Jun 2012
PDF形式PMDA Vision: Its Current Situation and Aim for the Future (PDF) Dr Kondo T, Chief Executive DIA 24th Annual EuroMeeting, Copenhagen, Denmark Mar 2012
PDF形式The Future Prospects of PMDA (PDF) Dr Utsumi H, Executive Director International Symposium on Past, Present and Future of Molecular Pharmacokinetics, Tokyo, Japan Jan 2011
Regulatory Science PDF形式Regulatory Science Research in PMDA (PDF) Dr Uyama Y, Office of Review Management 12th Kitasato-Harvard Symposium, Tokyo, Japan May 2013
PDF形式Regulatory use of innovative tools in drug development (PDF) Dr Uyama Y, Office of Review Management 2013 Harvard University-Pharmaceutical Regulatory Science Symposium, Boston, USA May 2013
PDF形式Regulatory Science Research in PMDA (PDF) Dr Uyama Y, Office of Regulatory Science 47th Annual DIA meeting, Chicago, USA Jun 2011
International Programs PDF形式International cooperation and consideration on Multi Regional Clinical Trial among Asia (PDF) Mr Uzu S, Office Director, Office of New Drug Ⅰ 25th DIA Annual EuroMeeting, amsterdam, Netherlands Mar 2013
PDF形式Consideration on Global Harmonization (PDF) Dr Nakashima N, Office of International Programs International Conference on Drug Regulatory Authorities, Tallinn, Estonia Oct 2012
PDF形式PMDA International Vision and Cooperation with Asian Drug Regulatory Authorities (PDF) Dr Tominaga T, Office of International Programs 6th Annual Conference in Japan for Asian New Drug Development, Tokyo, Japan Apr 2012
PDF形式APEC MRCT Roadmap: Regulatory authorities' efforts to promote multi regional clinical trials (MRCTs) (PDF) Dr Tominaga T, Office of International Programs DIA 24th Annual EuroMeeting, Copenhagen, Denmark Mar 2012
PDF形式EU, USA and Japan (II) - Reports from Regulators on Exchange Assignments (PDF) Mr Hayashi Y, Office of International Programs DIA 24th Annual EuroMeeting, Copenhagen, Denmark Mar 2012
New Drug PDF形式Japan PMDA and CDISC Standards (PDF) new Ando Y, Senior Scientist for Biostatistics CDISC International Interchange 2013, Bethesda, US Nov 2013
PDF形式PMDA's experiences to review data of bridging study based on ICH E5 guideline. (PDF) new Dr Uyama Y, Office of Review Management FIP SIG Regulatory Science Workshop, "Harmonization of Bridging Studies among Asia-Pacific Region, Taipei, Taiwan Nov 2013
PDF形式New trend of clinical development in Japan; from sequential bridging to simultaneous global development (PDF) new Dr Uyama Y, Office of Review Management FIP SIG Regulatory Science Workshop, "Harmonization of Bridging Studies among Asia-Pacific Region, Taipei, Taiwan Nov 2013
PDF形式Regulatory and statistical issues of Multi-regional Clinical Trials: "Reference Cases" and current situation in Japan (PDF) new Ando Y, Senior Scientist for Biostatistics ICSA/ISBS, Bethesda, US Jun 2013
PDF形式Principles and Case Examples in Global/Asian Clinical Trials (PDF) new Ando Y, Senior Scientist for Biostatistics 5th DIA China 2013 Annual Meeting, Beijing, China May 2013
PDF形式HEART FAILURE TRIALISTS WORKSHOP: Japanese Regulatory Viewpoint (PDF) Ms Ando Y, Senior Scientist for Biostatistics CVCT Forum 2012, Paris, France Dec 2012
PDF形式Genomics in patients with Japanese Ancestry (PDF) Dr Uyama Y, Office of Review Management EMA Workshop on Pharmacogenomics: From science to clinical care, London, UK Oct 2012
PDF形式Model Building Drug Development (MBDD) and Bridging in Asia - Japanese Regulatory Perspective (PDF) Dr Nagai N, Senior Scientist for Pharmacokinetics Center for Product Evaluation WCoP 2012, Seoul, Korea Sep 2012
PDF形式Looking beyond ICH-E9 in the Era of Global Drug Development (PDF) Ms Ando Y, Senior Scientist for Biostatistics Biostatistics Summer Workshop 2012, Osaka Aug 2012
PDF形式Design and Evaluation of Multiregional Clinical Trials: Experience in Japan (PDF) Ms Ando Y, Senior Scientist for Biostatistics 2012 Joint Statistical Meeting, San Diego, USA Aug 2012
PDF形式Asian Ethnic Similarities and Differences: PMDA Point of View (PDF) Dr Uyama Y, Office of Regulatory Science 48th Annual DIA meeting, Philadelphia, USA Jun 2012
PDF形式PMDA's Efforts to strengthen New Drug Review (PDF) Dr Yoda N, Office of New Drug III 4th DIA China Annual Meeting, Shanghai, China May 2012
PDF形式Is Extrapolation of Foreign QT Data Required? - A Regulatory Perspective (PDF) Ms Ando Y, Senior Scientist for Biostatistics 3rd Cardiac Safety Workshop in Japan, Tokyo, Japan May 2012
PDF形式Current Topics of Pharmaceutical Regulatory Affairs in Japan (PDF) Mr Sato T, Associate Center Director The 3rd China-Japan Symposium on Drug Development, Beijing, China Mar 2012
PDF形式Current position and expectation for use of M&S in drug development and regulatory decision making - The PMDA Viewpoint (PDF) Ms Ando Y, Senior Scientist for Biostatistics EMA-EFPIA Modelling and Simulation Workshop, London, UK Nov 2011
PDF形式Pre-consultation system at the authority for clinical trials and NDA in Japan (PDF) Mr Sato T, Associate Center Director The 6th Seminar Joint Taiwan and Japan, Taipei, Taiwan Nov 2011
PDF形式Multi-Regional Clinical Trialsin Global Drug Development: Update and Related Issues (PDF) Ms Ando Y, Senior Scientist for Biostatistics 2011 APEC MRCT Tokyo Workshop, Tokyo, Japan Nov 2011
PDF形式Comments on Adaptive Design (PDF) Ms Ando Y, Senior Scientist for Biostatistics 8th DIA Japan Annual Meeting, Tokyo, Japan Oct 2011
PDF形式Extrapolation of the non - Japanese TQT data to Japanese NDAs (PDF) Dr Shinagawa K, Senior Scientist for Clinical Medicine 2nd Cardiac Safety Workshop in Japan, Tokyo, Japan Sep 2011
PDF形式Acceptance of Clinical Data - The Challenge of Generalizability - (PDF) Ms Ando Y, Office of New Drug II Asia Regulatory Conference, Seoul, Korea Apr 2011
Biologics PDF形式Regulatory Updates on Cellular Therapy Products in Japan (PDF) Dr Kusakabe T, Office of Cellular and Tissue-based Products International Society for Cellular Therapy (ISCT), Auckland, New Zealand Apr 2013
PDF形式Recent Regulations of Biosimilars in Japan (PDF) Dr Arato T, Office of Biologics I 47th Annual DIA meeting, Chicago, USA Jun 2011
OTC, Generic Drugs PDF形式Approval Review of Generic Drugs in Japan (PDF) Ms Osa Y & Dr Saito K, Office of OTC/Generic Drugs Second International Generic Drug Regulators Meeting, Washington D.C., USA Apr 2012
Medical Devices PDF形式Overview of US-Japan Pilot Program Regarding Collaborative Consultation and Review(PDF) Dr Ho M, Office of Medical Devices Ⅰ HBD Think Tank East 2013, Tokyo, Japan Jul 2013
PDF形式The Overview of PMDA Activities (PDF) Dr Tamura A, International Coordination Officer for Medical Devices 3rd China International Medical Device Regulatory Forum, Beijing, China Sep 2012
PDF形式Regulatory Issues for PAD Devices (PDF) Dr Ikeda K, Office of Medical Devices I Transcatheter Cardiovascular Therapeutics (TCT) conference 2011, San Francisco, USA Nov 2011
PDF形式Current status of orphan device development in Japan (PDF) Dr Suzuki Y, Office of Medical Devices II AdvaMed 2011: The MedTech Conference, Washington D.C., USA Sep 2011
PDF形式Understanding Japanese Medical Device Requirements (PDF) Dr Tamura A, International Coordination Officer for Medical Devices 2011 AHC Workshop on Medical Devices:" Implementation of GHTF Documents", Seoul, Korea Jul 2011
PDF形式Understanding Japanese Medical Device Requirements Japan's experimence to implement international guidance documents (PDF) Dr 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) PDF形式The PMDA's GCP Inspection Methods, the Current State of Overseas GCP on-site inspections by PMDA (PDF) Ms Kondo E, Office of Conformity Audit The 3rd China-Japan Symposium on Drug Development, Beijing, China Mar 2012
PDF形式The role of conformity audits of GCP inspections in Japanese authority and the quality of clinical trials in Japan. (PDF) Dr Anahara R et al., Office of Conformity Audit The Society of Toxicology 51st Annual Meeting, San Francisco, USA Mar 2012
PDF形式Data Quality - from Inspectors' Point of View - (PDF) Dr Osawa T, Office of Conformity Audit 15th Annual Workshop in Japan for Clinical Data Management, Tokyo, Japan Jan 2012
PDF形式Japanese National GLP Monitoring Programme on Medical Products (PDF) Mr Sato Y, Office of Conformity Audit 3rd Global Quality Assurance Conference, Kyoto, Japan Nov 2011
PDF形式What we can do to ensure the quality (PDF) Dr 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 PDF形式Examples of Observations in GMP Compliance Inspections, and Related Problems (Manufacturer / Market Authorization Holder / In-country Caretaker of MF, etc.) (Chinese) (PDF) Mr Morisue M, Office of GMP/QMS Inspection CPhI China 2013, Shanghai, China Jun 2013
PDF形式PMDA GMP Inspection Mr Morisue M, Office of GMP/QMS Inspection 2nd India - Japan Pharmaceutical Seminar, Osaka Apr 2013
PDF形式Examples of Observations in PMDA GMP Compliance Inspections (Chinese) (PDF) Mr Morisue M, Office of GMP/QMS Inspection CPhI China 2012, Shanghai, China Jun 2012
PDF形式Current Situation and Updates of QMS Inspection in Japan (PDF) Dr Makino T, Office of GMP/QMS Inspection RAPS 2011 The Regulatory Convergence, Indianapolis, USA Oct 2011
PDF形式Medical device QMS/GMP system and audit (PDF) Mr Ishibashi K, Office of GMP/QMS Inspection 2011 AHC Workshop on Medical Devices: "Implementation of GHTF Documents", Seoul, Korea Jul 2011
Safety PDF形式Direct Patient ADR reporting system in Japan (PDF) Mr Mori K, Chief Safety Officer 48th Annual DIA meeting, Philadelphia, USA Jun 2012
PDF形式Pharmacovigilance in Japan and Risk Management Plans (RMP); Regulator Perspective (PDF) Mr Mori K, Chief Safety Officer 48th Annual DIA meeting, Philadelphia, USA Jun 2012
PDF形式PMDA's Recent Developments in Enhancement of Drug Safety Measures (PDF) Ms Ikeda M, Office of Safety I DIA 24th Annual EuroMeeting, Copenhagen, Denmark Mar 2012
PDF形式Pharmacovigilance Activities in Japan (PDF) Dr Hori A, Office of Safety II WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden May 2011
Relief Funds PDF形式Relief Service for Adverse Health Effects in Japan (PDF) Dr Miyazaki S, Office of Relief Funds PMDA training seminar, Tokyo, Japan Nov 2010