Role and Vision of PMDA

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Role and Vision of PMDA"

Transcription

1 Role and Vision of PMDA ~Promoting Global Public Health~ Taisuke Hojo Senior Executive Director Pharmaceutical and Medical Devices Agency (PMDA) 1 st Malaysia-Japan Symposium March 10 th, 2015

2 Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 2

3 Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 3

4 Pharmaceuticals and Medical Devices Agency Date of Establishment : April Major Services Scientific Review for Drugs & Medical Devices GCP, GMP Inspection Consultation on Clinical Trials Safety Measures Relief Services Unique Three-pillar System Securing Nation s Safety Review Kansai Branch Safety Japanese citizens Relief 4

5 Work Flow of Drugs Development R & D Non-Clinical Study Clinical Trial Application Post-marketing GLP Inspection GCP Inspection GMP/QMS Inspection GPSP/GVP Inspection R&D Promotion Clinical Trial Consultation Review Post-marketing Safety Operations Relief National Institute of Biomedical Innovation (Established in April 2005) Health Policy Bureau MHLW Pharmaceuticals and Medical Devices Agency (Established in April 2004) Review Report Approval Minister of Health Labour and Welfare (Pharmaceutical and Food Safety Bureau) Recall Orders etc. Pharmaceutical Affairs and Food Sanitation Council (PAFSC) 5

6 Organization of PMDA Associate Center Director Office of Regulatory Science Executive Director Associate Executive Director Office of Standards and Guidelines Development Office of Review Administration Director of Center for Product Evaluation Associate Executive Director Office of Review Management Office of International Programs International Coordination/Liaison Officers Chief Executive Deputy Center Director (for Cellular and Tissuebased Products) Associate Center Director Associate Center Director Associate Executive Director Offices of New Drug I-V Office of Cellular and Tissue-based Products Office of Vaccines and Blood Products Offices of OTC/Quasi-Drugs Office of Generic Drugs Offices of Medical Devices I-III Auditor Auditor Deputy Center Director (for Medical Devices) Office of Conformity Audit Principal Senior Scientists Senior Scientists Associate Center Director Advanced Review with Electric Data Promotion Group Senior Executive Director Chief Safety Officer Kansai Branch Office of Manufacturing/ Quality and Compliance Offices of Safety I, II Associate Executive Director Information Technology Promotion Group Audit Office As of November 1, 2014 Executive Director Deputy Executive Director Chief Relief Officer Chief Management Officer Chief Actuary Office of Relief Funds Offices of General Affairs / Office of Financial Management / Office of Planning and Coordination

7 PMDA Staff Size Administrative part Review Department Safety Department Planned

8 Our Philosophy (September, 2008) PMDA continues to improve the public health and safety of our nation by reviewing applications for marketing approval of pharmaceuticals and medical devices, conducting safety measures, and providing relief to people who have suffered from adverse drug reactions. We conduct our mission in accordance with the following principles: We pursue the development of medical science while performing our duty with greater transparency based on our mission to protect public health and the lives of our citizens. We will be the bridge between the patients and their wishes for faster access to safer and more effective drugs and medical devices. We make science-based judgments on quality, safety, and efficacy of medical products by training personnel to have the latest technical knowledge and wisdom in their field of expertise. We play an active role within the international community by promoting international harmonization. We conduct services in a way that is trusted by the public based on our experiences from the past. 8

9 3 rd 5-year mid-term plan of PMDA (FY ) 4 Major challenges Shortening the time from early development to approval Measures: improvement in consultation system, accelerated review process, etc. High quality review/consultation services Measures: promotion of regulatory science research, etc. Enhancing safety measures Measures: utilization of medical information database Globalization Measures: information transfer with the world

10 Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 10

11 Team Reviewing at the PMDA Reviewers are required to have a high level of expertise Office Director Review Director Team Leader CMC Toxicology ADME Biostatistics Pharmacology Clinical Risk Manager 11

12 Japan s Performance on NDA Review Reference: The impact of the changing regulatory environment on the approval of new medicines across six major authorities CIRS (Centre for Innovation in Regulatory Science) R&D

13 Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 13

14 Adverse Drug Reaction (ADR) Reporting System in Japan Investigation Reporting Reporting Health Care Providers FAX Postal Mail Electronic reporting Analyze and evaluate collected data Feedback Marketing Authorization Holders (MAH) Pharmacies Safety Measures

15 Goal of MIHARI Project & MID-NET Create new DB = MID-NET 15

16 Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 16

17 Drug Risk & Relief Non-clinical study Clinical Trial Review Post-marketing Risk Benefit It is impossible to prevent risks completely even with benefit of Revolutionary technology Social Risk Proper usage Pharmaceutical Manufacturers, etc Social Relief System Contribution Relief Fund Relief benefits Medical costs Disability pension etc. Patients *Infectious Disease Relief Launched in April

18 Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 18

19 Summit APEC LSIF RHSC Abbreviation Summit ICH IMDRF PIC/S HBD ICDRA APEC LSIF RHSC OECD MAD PDG IGDRP ICMRA ICH OECD Global Activities IMDRF PIC/S HBD ICDRA PDG Official Name International Summit of Heads of Medicines Regulatory Agencies International Conference on Harmonization International Medical Device Regulators Forum Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Harmonization By Doing IDGRP ICMRA and more International Conference of Drug Regulatory Authorities APEC Life Science Innovation Forum Regulatory Harmonization Steering Committee OECD Mutual Acceptance of Data Pharmacopoeial Discussion Group International Generic Drug Regulators Pilot International Coalition of Medicines Regulatory Authorities

20 PMDA and the World Confidentiality Arrangement Memorandum of Understanding (MOU) Resident Staff Joint Symposium (forth coming) Health Canada, Canada FDA, US ANVISA, Brazil IMB, Ireland EMA(EU) MHRA, UK ANSM, France CBG-MEB, Netherlands AIFA, Italy Swissmedic, Switzerland CFDA, China TFDA, Thailand * HSA, Singapore PMDA Tokyo & Osaka, Japan Taiwan FDA, ** Taiwan NPCB, Malaysia NADFC, Indonesia TGA, Australia MOU between the Chinese SFDA (present CFDA) and the Japanese MHLW, under which PMDA supports cooperative activities ** MOU concluded between Interchange Association and East Asia Relations Commission, but is being implemented through cooperation of related organizations.

21 Dissemination of Information Review Report Safety Information PMDA Updates News Release And more 21

22 Training for Foreign Regulatory Officers PMDA Training Seminar Pharmaceuticals: 1st (Nov. 2010) Reviewing of New Drugs 2nd (Dec. 2011) GMP inspection 3rd (Jan. 2013) Post-Marketing Safety & Relief Services 4th (Feb. 2014) Reviewing of Generic Drugs Medical Devices: 1 st (Mar. 2014) Medical Device Regulation 2 nd (Feb. 2015) Individual Training (including OJT) NADFC (Indonesia) officials: 5 days, 2013 FDA (US) analyst: 6 months, NPBC (Malaysia) officials: 1 month, 2014 Thai FDA (Thailand) officials: 5 days, etc.

23 Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 23

24 Toward Global PMDA Approve innovative products first in the world! Strengthen post marketing safety measures Safety Review Japanese citizens Spread technology of Japanese origin world-wide Collaborate with review organizations globally Timely relief for acknowledged damage Health damage relief The society where people can receive necessary healthcare services at the most advanced level Extend healthy life expectancy for Japanese citizens Contribute to global healthcare 24

25 Thank you very much for your attention. 25

International trend on medical device regulatory convergence

International trend on medical device regulatory convergence International trend on medical device regulatory convergence Mari Shirotani, Ph.D. Division Director, Office of International Programs Pharmaceuticals and Medical Devices Agency (PMDA) 1st December, 2017

More information

International regulatory activities based on PMDA International Strategic Plan 2015

International regulatory activities based on PMDA International Strategic Plan 2015 TOPRA Annual Human Medicines Symposium 2017 International regulatory activities based on PMDA International Strategic Plan 2015 Hideyuki Kondo, MHLW/PMDA Liaison Official at EMA Pharmaceuticals and Medical

More information

PMDA Update: Its current situation

PMDA Update: Its current situation PMDA Update: Its current situation and future direction Tatsuya Kondo, M.D. Ph.D. Chief Executive Pharmaceuticals and Medical Devices Agency (PMDA), Japan 25th Annual EuroMeeting 4-6 March 2013 RAI, Amsterdam

More information

GCP Inspection by PMDA

GCP Inspection by PMDA 2012 EU GCP Inspectors Working Group Workshop London, 12-14 November 2012 Practical Experience in GCP inspections, non EU/EEA countries GCP Inspection by PMDA Kazuko Natsui Inspector for GCP Inspection,

More information

Consideration on Global Harmonization

Consideration on Global Harmonization ICDRA Workshop I Consideration on Global Harmonization Oct. 25, 2012 Dr. Nobumasa Nakashima Director, Office of International Programs PMDA, Japan 1 Current Harmonization Activities ICH: International

More information

Forward looking approaches & its Experiences of PMDA's ATC

Forward looking approaches & its Experiences of PMDA's ATC 6 th Asia Partnership Conference of Pharmaceutical Associations, Tokyo, 5 th April 2017 Forward looking approaches & its Experiences of PMDA's ATC Junko Sato, PhD Office Director, Office of International

More information

The overview of PMDA activities

The overview of PMDA activities The overview of PMDA activities Atsushi TAMURA, Ph.D. International Coordination Officer for Medical Devices Pharmaceuticals & Medical Devices Agency Who are we? PMDA (Pharmaceuticals and Medical Devices

More information

2. The 2nd PMDA Medical Devices Training Seminar (February 2 to 6)

2. The 2nd PMDA Medical Devices Training Seminar (February 2 to 6) PMDA Updates February, 2015 Daphne odora Thunb. News 1. APEC LSIF RHSC (January 28 to 31) APEC Life Science Innovations Forum (LSIF) Regulatory Harmonization Steering Committee (RHSC) was held in Clark,

More information

Mid-term Targets of the Pharmaceuticals and Medical Devices Agency (PMDA) *(Provisional Translation)

Mid-term Targets of the Pharmaceuticals and Medical Devices Agency (PMDA) *(Provisional Translation) Mid-term Targets of the Pharmaceuticals and Medical Devices Agency (PMDA) *(Provisional Translation) * This translation of the original Japanese text is for information purposes only (in the event of inconsistency,

More information

1. Medical Devices Subcommittee meeting held (June 12)

1. Medical Devices Subcommittee meeting held (June 12) PMDA Updates July, 2013 Nerium oleander News 1. Medical Devices Subcommittee meeting held (June 12) The Medical Device Subcommittee, one of the four subcommittees of the Science Board, had its 4th meeting

More information

Direct Patient ADR reporting system in Japan. Kazuhiko Mori, Chief Safety Officer Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Direct Patient ADR reporting system in Japan. Kazuhiko Mori, Chief Safety Officer Pharmaceuticals and Medical Devices Agency (PMDA), Japan Direct Patient ADR reporting system in Japan Kazuhiko Mori, Chief Safety Officer Pharmaceuticals and Medical Devices Agency (PMDA), Japan Disclaimer The views and opinions expressed in the following PowerPoint

More information

Progress Report in 2016

Progress Report in 2016 APAC Position Paper Progress Report in 2016 APAC RA-EWG Table of Contents INTRODUCTION 1 PROGRESS REPORT ON FOCUSED TOPIC(S) 3 IPMG (International Pharmaceutical Manufacturers Group) 3 JPMA (Japan Pharmaceutical

More information

Trends in the development of regulatory systems by the example of ICH countries

Trends in the development of regulatory systems by the example of ICH countries Trends in the development of regulatory systems by the example of ICH countries Author: Pär Tellner, Member of ICH Management Committee (ICH MC), EFPIA * Date: 27/08/2018 * GMP conference, Kazan, Russia

More information

ICH Regulators Forum. Dr Peter Arlett EU

ICH Regulators Forum. Dr Peter Arlett EU Dr Peter Arlett EU International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use In this presentation ICH Regulators Forum: Background ICH Regulators

More information

PMDA EPOCH Toward 2020

PMDA EPOCH Toward 2020 PMDA International Vision PMDA EPOCH Toward 2020 As one of the world s top three medical products regulatory agencies comparable to its American and European counterparts, PMDA aims to: 1. Secure the highest

More information

Current status on Adverse Event Reporting in Japan

Current status on Adverse Event Reporting in Japan Current status on Adverse Event Reporting in Japan Iku Mitta Safety Reports Management Division, Office of Safety I PMDA 1 Abbreviation ADR: Adverse Drug Reaction DB: Database EPPV:Early Post-Marketing

More information

Tomoko OSAWA, Ph.D. Director for GCP Inspection Office of Conformity Audit PMDA, Japan

Tomoko OSAWA, Ph.D. Director for GCP Inspection Office of Conformity Audit PMDA, Japan Tomoko OSAWA, Ph.D. Director for GCP Inspection Office of Conformity Audit PMDA, Japan The views presented in this presentation are those of the author and should not be understood or quoted as being made

More information

EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS

EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL

More information

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL

More information

Report on collaborative activities related to QSD/QMS

Report on collaborative activities related to QSD/QMS Report on collaborative activities related to QSD/QMS 2nd Joint Conference of Taiwan and Japan on Medical Products Regulation 31 Oct 2014 QSD/QMS WG 1 Members of QSD/QMS Working Group Taiwan Group Ms.

More information

Expectation to International Harmonization from Pharmaceutical Industry. Masafumi Yokota, DVM, PhD JPMA ICH Project Committee Dec 3, 2018

Expectation to International Harmonization from Pharmaceutical Industry. Masafumi Yokota, DVM, PhD JPMA ICH Project Committee Dec 3, 2018 Expectation to International Harmonization from Pharmaceutical Industry Masafumi Yokota, DVM, PhD JPMA ICH Project Committee Dec 3, 2018 Outline 1. JPMA Industry Vision 2025 2. Challenges in Regulatory

More information

July 23, (

July 23, ( July 23, 2014 First Expression of Interest (EOI) to Participate in an Information Sharing Pilot for the Evaluation of Generic Drug Applications involving the Decentralised Procedure (DCP) of the European

More information

3. Special training given by academic staffs from Medical University of Vienna (March 27)

3. Special training given by academic staffs from Medical University of Vienna (March 27) PMDA Updates April, 2015 Cerasus News 1. PMDA s staff size expanded (April 1) The total number of executives and employees has increased by 67 from April 1, 2014 to 820 on April 1, 2015, of which 532 belong

More information

Our Way to CDISC Submissions An Update 12 Months Later

Our Way to CDISC Submissions An Update 12 Months Later Our Way to CDISC Submissions An Update 12 Months Later Yuki Ando Senior Scientist for Biostatistics Advanced Review with Electronic Data Promotion Group Pharmaceuticals and Medical Devices Agency (PMDA)

More information

Notice Our file number:

Notice Our file number: October 22, 2010 Notice Our file number: 10-121855-881 Adoption of International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use Guidance:

More information

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL

More information

Overview of ICH. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Overview of ICH. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Overview of ICH June 2018 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH Legal notice Legal Notice This presentation is protected by copyright and

More information

Sun Hee Lee, Ph.D. Director General Drug Evaluation Department Korea Food and Drug Administration

Sun Hee Lee, Ph.D. Director General Drug Evaluation Department Korea Food and Drug Administration Sun Hee Lee, Ph.D. Director General Drug Evaluation Department Korea Food and Drug Administration Contents AHC A Brief Overview 2010 AHC Training Programs AHC Workshops in 2011 Future Plan AHC A Brief

More information

EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON DISINTEGRATION TEST GENERAL CHAPTER Q4B ANNEX 5

EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON DISINTEGRATION TEST GENERAL CHAPTER Q4B ANNEX 5 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL

More information

Audit and Inspection

Audit and Inspection Audit and Inspection DIPLOMA COURSE on Research & Development of Products for Public Health Needs Thammasat University, Thailand 28 November, 2008 Dr. Allan K. Johansen, Roche Products Pty Limited, Australia

More information

EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS

EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL

More information

Why do we need an addendum to ICH E6?

Why do we need an addendum to ICH E6? Addendum to ICH E6 Hideaki Ui, Ph.D. Inspection Director Office of Non-clinical and Clinical Compliance Pharmaceuticals and Medical Devices Agency, Japan Disclaimer The views and opinions expressed in

More information

International Medical Device Regulatory Harmonization. Reality or Fantasy?

International Medical Device Regulatory Harmonization. Reality or Fantasy? International Medical Device Regulatory Harmonization Reality or Fantasy? Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress Harvard University; 28-30 March 2007 M. Gropp; Medtronic,

More information

I C H INTERNATIONAL CONFERENCE ON HARMONISATION of Technical Requirements for the Registration of Pharmaceuticals for Human Use

I C H INTERNATIONAL CONFERENCE ON HARMONISATION of Technical Requirements for the Registration of Pharmaceuticals for Human Use MedDRA: an ICH Success Story ASEAN MedDRA Training Kuala Lumpur, March 17-19, 2010 Dr. Christina Winter, Medical Director Global Clinical Safety & Pharmacovigilance GlaxoSmithKline R&D EFPIA ICH MedDRA

More information

The place of the Certification procedure in 2017 in the EU regulatory framework and beyond. Prague, 19 September 2017

The place of the Certification procedure in 2017 in the EU regulatory framework and beyond. Prague, 19 September 2017 The place of the Certification procedure in 2017 in the EU regulatory framework and beyond Prague, 19 September 2017 Hélène BRUGUERA Head of the Certification Department, EDQM, Council of Europe CEPs in

More information

New Streams of Risk Management. Tomiko TAWARAGI Chief Safety Officer Pharmaceuticals and Medical Devices Agency (PMDA)

New Streams of Risk Management. Tomiko TAWARAGI Chief Safety Officer Pharmaceuticals and Medical Devices Agency (PMDA) New Streams of Risk Management Tomiko TAWARAGI Chief Safety Officer Pharmaceuticals and Medical Devices Agency (PMDA) 1 Disclaimer The views and opinions expressed in the following PowerPoint slides are

More information

International Trend on Medical Device Regulatory Convergence

International Trend on Medical Device Regulatory Convergence International Trend on Medical Device Regulatory Convergence 5th Joint Conference of Taiwan and Japan on Medical Products Regulation December 1, 2017 Taipei 1 Content Overview of major international harmonization

More information

Computer Validation Initiative Committee Membership Requirements

Computer Validation Initiative Committee Membership Requirements SOP No. CV-02.03 Supersedes SOP No. CV-02.02 Effective Page 1 of 5 Original Issue 18 February 2002 Retirement Computer Validation Initiative Committee Membership Requirements 1. Significant Change(s) from

More information

Addendum to ICH E6 (R2)

Addendum to ICH E6 (R2) Addendum to ICH E6 (R2) Stephanie Shapley (US FDA) - Rapporteur Dr. Fergus Sweeney (EMA) - Regulatory Chair Date: December 15, 2015 International Council for Harmonisation of Technical Requirements for

More information

Current Status and Issues With Global Acceptance of ICH. Jurij Petrin, M.D.

Current Status and Issues With Global Acceptance of ICH. Jurij Petrin, M.D. Current Status and Issues With Global Acceptance of ICH Jurij Petrin, M.D. 1 ICH History Meeting in April 1990, hosted by the EFPIA in Brussels Representatives of the regulatory agencies and industry associations

More information

Companies are realizing the value of. cost-effective option. an opinion regarding a business company performance.

Companies are realizing the value of. cost-effective option. an opinion regarding a business company performance. SPEAKER:- CHINMOY ROY WORLD COMPLIANCE SEMINARS WORLD COMPLIANCE SEMINARS BSEE, MSCS US FDA EXPERT DATA INTEGRITY & CSV. SPEAKER:- David R. Dills Global Regulatory Affairs & Compliance Consultant and President,

More information

Post Market Surveillance and Vigilance in Japan. Medical Device Safety Division, Office of Safety I

Post Market Surveillance and Vigilance in Japan. Medical Device Safety Division, Office of Safety I Post Market Surveillance and Vigilance in Japan Medical Device Safety Division, Office of Safety I 1 Overview of Adverse Event Reporting 医療機関 Healthcare professionals /facilities 2. Investigation 3. Investigation

More information

Evolution and achievements of ICH- GCG (Global Cooperation Group)

Evolution and achievements of ICH- GCG (Global Cooperation Group) Evolution and achievements of ICH- (Global Cooperation Group) Kohei Wada VP/General Manager, Asia Development Dept, Daiichi Sankyo, Japan JPMA representative, ICH Steering Committee & Co-chair, ICH Version

More information

Regional Update ASEAN PPWG

Regional Update ASEAN PPWG Regional Update ASEAN PPWG by Yuppadee JAVROONGRIT, Ph.D. Co-Chair of ACCSQ/PPWG, ASEAN Drug Control Division, ThaiFDA, Thailand The ICH-Global Cooperation Group Meeting Yokohama Royal Park Hotel, Yokohama,

More information

(Yokohama Royal Park Hotel)

(Yokohama Royal Park Hotel) INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE GLOBAL COOPERATION GROUP MEETING REPORT TUESDAY OCTOBER 30, 2007 Ref: GCG 78F Yokohama,

More information

2015 Annual FDA Medical Device Quality System Data. Inspections, FDA Form 483 Observations, and Warning Letter Citations

2015 Annual FDA Medical Device Quality System Data. Inspections, FDA Form 483 Observations, and Warning Letter Citations 2015 Annual FDA Medical Device Quality System Data Inspections, FDA Form 483 Observations, and Warning Letter Citations Why is FDA making these data available? In support of the FDA s Transparency and

More information

JICWELS. Human Resources Development. International Conference / Meeting. Project and Study. Acceptance of Foreign Professionals

JICWELS. Human Resources Development. International Conference / Meeting. Project and Study. Acceptance of Foreign Professionals Japan International Corporation of Welfare Services (JICWELS) was established with the sanction of the Ministry of Health, Labour and Welfare in July 1983 for the purpose of contributing to the promotion

More information

A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program

A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES IN SINGAPORE (GDPMDS)

More information

MDSAP: A Successful Work in Progress

MDSAP: A Successful Work in Progress MDSAP: A Successful Work in Progress Brian Ludovico Executive Director, MDSAP Regulatory Certification Health Sciences Medical Devices NSF International Outline 1. Where it all began 2. How we ve grown

More information

Open Access Publishing at Nature Publishing Group. Antoine Bocquet Director, Asia-Pacific SPARC Japan Seminar February 29 th 2012, Tokyo

Open Access Publishing at Nature Publishing Group. Antoine Bocquet Director, Asia-Pacific SPARC Japan Seminar February 29 th 2012, Tokyo Open Access Publishing at Nature Publishing Group Antoine Bocquet Director, Asia-Pacific SPARC Japan Seminar February 29 th 2012, Tokyo Workflow: Submission to Publication NPG s Open Access activities

More information

Medical Devices Program Update

Medical Devices Program Update Medical Devices Program Update Cindy Evans Interim Senior Executive Director Therapeutic Products Directorate Health Products and Food Branch April 29, 2015 Classification of Medical Devices Medical Device

More information

Transmission to CHMP December Adoption by CHMP for release for consultation December 2008

Transmission to CHMP December Adoption by CHMP for release for consultation December 2008 September 2010 EMA/CHMP/ICH/645469/2008 ICH guideline Q4B annex 7 (R2) to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on dissolution test general chapter Step

More information

Transmission to CHMP December Adoption by CHMP for release for consultation December 2008

Transmission to CHMP December Adoption by CHMP for release for consultation December 2008 September 2015 EMA/CHMP/ICH/645408/2008 Committee for Human Medicinal Products ICH guideline Q4B annex 6 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on

More information

Food Safety Capacity Building: The role of public private partnerships

Food Safety Capacity Building: The role of public private partnerships Food Safety Capacity Building: The role of public private partnerships Paul Young, PhD Senior Director, Food and Environment Business Operations, Waters Corporation 2011 Waters Corporation 1 Background

More information

FINAL STATUS DOCUMENT

FINAL STATUS DOCUMENT GHTF/SG2/N68R3: 2005 FINAL STATUS DOCUMENT Global Harmonization Task Force Title: Summary of Current Requirements for Where to Send Adverse Event Reports. Authoring Group: GHTF Study Group 2 Endorsed by:

More information

Training components for GCP. inspectors in PMDA. Tomonori Tateishi, MD, PhD Office of Conformity Audit, PMDA

Training components for GCP. inspectors in PMDA. Tomonori Tateishi, MD, PhD Office of Conformity Audit, PMDA Training components for GCP inspectors in PMDA Tomonori Tateishi, MD, PhD Office of Conformity Audit, PMDA Content 1. Conformity inspection in the training program for newcomers to PMDA 2. The training

More information

II. OPERATION RESULTS / ACHIEVEMENT OF FY 2005

II. OPERATION RESULTS / ACHIEVEMENT OF FY 2005 II. OPERATION RESULTS / ACHIEVEMENT OF FY 2005 PART 1. IMPROVEMENT IN OVERALL OPERATIONS AND SERVICE QUALITY OF THE AGENCY (1) Development and Implementation of 2005 Fiscal Year Plan The Agency is required

More information

ANVISA - Enhancing marketing authorization of drugs and medical devices in accordance to the international best practices

ANVISA - Enhancing marketing authorization of drugs and medical devices in accordance to the international best practices ANVISA - Enhancing marketing authorization of drugs and medical devices in accordance to the international best practices Balbiana Verazez Sampaio Oliveira AGENDA 1. Strategic Plan 2016-2019 objectives

More information

Regional Alignment in Asia Pacific -

Regional Alignment in Asia Pacific - Regional Alignment in Asia Pacific - a Perspective from the Chair of the APEC Regulatory Harmonization Steering Committee (RHSC) Mike Ward Chair, APEC RHSC 3 rd Annual DIA Latin American Regulatory Conference

More information

ICH Topic Q4B Annex 6 Uniformity of Dosage Units General Chapter. Step 3

ICH Topic Q4B Annex 6 Uniformity of Dosage Units General Chapter. Step 3 European Medicines Agency December 2008 EMEA/CHMP/ICH/645408/2008 ICH Topic Q4B Annex 6 Uniformity of Dosage Units General Chapter Step 3 ANNEX 6 TO NOTE FOR EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL

More information

Capacity building and technical assistance to regulators; Regulatory cooperation and harmonization initiatives

Capacity building and technical assistance to regulators; Regulatory cooperation and harmonization initiatives Capacity building and technical assistance to regulators; Regulatory cooperation and harmonization initiatives Dr Samvel Azatyan Group Lead Capacity Building and Harmonization Support Regulatory Systems

More information

Post market surveillance/vigilance in Japan -Industry perspective- Hideki Watanabe JFMDA PMS committee Terumo corporation PMS Dept.

Post market surveillance/vigilance in Japan -Industry perspective- Hideki Watanabe JFMDA PMS committee Terumo corporation PMS Dept. Post market surveillance/vigilance in Japan -Industry perspective- Hideki Watanabe JFMDA PMS committee Terumo corporation PMS Dept. 28 August, 2018 Disclaimers Translation note English and Japanese are

More information

MESSAGE FROM THE ASSISTANT DEPUTY MINISTER

MESSAGE FROM THE ASSISTANT DEPUTY MINISTER Health Canada Santé Canada Inspectorate Program Annual Inspection Summary Report 2015 2016 MESSAGE FROM THE ASSISTANT DEPUTY MINISTER I am pleased to present Health Canada s 2015 2016 Annual Inspection

More information

ACTION PLAN/WORK PROGRAM FOR THE ACCSQ PREPARED FOODSTUFF PRODUCT WORKING GROUP

ACTION PLAN/WORK PROGRAM FOR THE ACCSQ PREPARED FOODSTUFF PRODUCT WORKING GROUP ACTION PLAN/WORK PROGRAM FOR THE ACCSQ PREPARED FOODSTUFF PRODUCT WORKING GROUP ASEAN OVERALL GOAL PFPWG GOAL : TBT for Prepared Foodstuff among ASEAN member States eliminated : ASEAN MRA for Prepared

More information

Expectation and Demands of Clinical Trial Capacity from Overseas-Status quo of Taiwan

Expectation and Demands of Clinical Trial Capacity from Overseas-Status quo of Taiwan Expectation and Demands of Clinical Trial Capacity from Overseas-Status quo of Taiwan Professor Oliver Yoa-Pu Hu Ph.D. Dean Research and Development National Defense Medical Center Taipei, Taiwan, ROC.

More information

Asia-Pacific Economic Cooperation

Asia-Pacific Economic Cooperation Asia-Pacific Economic Cooperation What is Asia-Pacific Economic Cooperation? Asia-Pacific Economic Cooperation, or APEC, is the premier forum for facilitating economic growth, trade and investment in the

More information

Responsible medication processes ( pharmaceutical care ) and good pharmaceutical practices for improved patients quality of life and batter healthcare

Responsible medication processes ( pharmaceutical care ) and good pharmaceutical practices for improved patients quality of life and batter healthcare Responsible medication processes ( pharmaceutical care ) and good pharmaceutical practices for improved patients quality of life and batter healthcare INTRODUCTION This summary provides - an evaluation

More information

4th International Medical Expo & Conference

4th International Medical Expo & Conference Exhibiting Information 4th International Medical Expo & Conference 2018 Dates: February 21(Wed)- 23 (Fri), 2018 Venue: INTEX Osaka, Japan Organised by: Reed Exhibitions Japan Ltd. Supported by: Union of

More information

Good Review Practices A Common Regulatory. the CTD. 34rd Latin American Regulatory Conference. Justina A. Molzon, MS Pharm, JD

Good Review Practices A Common Regulatory. the CTD. 34rd Latin American Regulatory Conference. Justina A. Molzon, MS Pharm, JD 34rd Latin American Regulatory Conference Panama City, Panama--April 13-15 15, 2011 Good Review Practices A Common Regulatory Language Influenced by the CTD Justina A. Molzon, MS Pharm, JD Center for Drug

More information

Reflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP Compliance Problems. Outcome of 10 September 2012 Workshop

Reflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP Compliance Problems. Outcome of 10 September 2012 Workshop Reflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP Compliance Problems Outcome of 10 September 2012 Workshop Management Board Meeting - Agenda Point B10 04 October 2012

More information

Hiromichi Shirasawa, MD

Hiromichi Shirasawa, MD Hiromichi Shirasawa, MD MSD office: 1-13-12 Kudan-kita Chiyoda-ku Tokyo Japan #102-8667 Office: +81 (0)3 6272 2102 Mobile: +81 (0)80 8700 8466 email: hiromichi.shirasawa@merck.com Summary of Profile Received

More information

Completing E2B(R3) Compliance in Total Safety 7

Completing E2B(R3) Compliance in Total Safety 7 @ris global Let s Innovate for Life 2016 Completing E2B(R3) Compliance in Total Safety 7 Author: Christian Schmitz-Moormann, Senior Director, Leading Practices Mark Loudon Senior Director, Risk Management

More information

Anna Hegerius, MSc Pharm Team Leader, Education & Training

Anna Hegerius, MSc Pharm Team Leader, Education & Training Anna Hegerius, MSc Pharm Team Leader, Education & Training UMC/WHO guidelines (2000) Available in: English Spanish French Russian Italian Korean Portuguese 2 Anna Hegerius, Uppsala Monitoring Centre http://www.who.int/medicines/areas/quality_safety/safety_efficacy/saf_pub/en/

More information

NO (maybe in progress)

NO (maybe in progress) ISPOR Asia Pacific 2018, Tokyo Japan Second Plenary Session: Monday, 10 September 2018, 8:30 AM - 10:00 AM Real World Evidence in Asia-Pacific: Are We Ready? Is It Helpful for Decision Makers? Database,

More information

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE GLOBAL COOPERATION GROUP MEETING REPORT TUESDAY JUNE 8, 2010 PARTICIPANTS: Ms. Lenita

More information

FINAL STATEMENT BY THIRD APEC HIGH LEVEL MEETING ON HEALTH AND THE ECONOMY

FINAL STATEMENT BY THIRD APEC HIGH LEVEL MEETING ON HEALTH AND THE ECONOMY FINAL STATEMENT BY THIRD APEC HIGH LEVEL MEETING ON HEALTH AND THE ECONOMY The third APEC High Level Meeting on Health and the Economy (HLM3) was held in Nusa Dua, Bali, Indonesia, on 24-25 September 2013.

More information

SUMMARY REPORT OF THE 17 th ACCSQ MDPWG MEETING

SUMMARY REPORT OF THE 17 th ACCSQ MDPWG MEETING SUMMARY REPORT OF THE 17 th ACCSQ MDPWG MEETING INTRODUCTION 1) The 17 th Meeting of the Medical Device Product Working Group (MDPWG) was held on 25-26 April 2013 in Petaling Jaya, Malaysia. The Meeting

More information

IVD/MD Asian Working Group Emerging Market Research Report No.2

IVD/MD Asian Working Group Emerging Market Research Report No.2 IVD/MD Asian Working Group Emerging Market Research Report No.2 Country of Visit : Thailand Time of Visit : November 2015 Visitor: one representative from JACRI Two representatives from JAIMA Visiting

More information

2008/SOM1/MAG/WKSP/002 Session: 1. Digital Prosperity. Submitted by: Information Technology & Innovation Foundation

2008/SOM1/MAG/WKSP/002 Session: 1. Digital Prosperity. Submitted by: Information Technology & Innovation Foundation 2008/SOM1/MAG/WKSP/002 Session: 1 Digital Prosperity Submitted by: Information Technology & Innovation Foundation Workshop on Information Technology / Electronics Industry Lima, Peru 20 February 2008 Presentation

More information

APEC LSIF Blood Supply Chain Initiative Overview

APEC LSIF Blood Supply Chain Initiative Overview 2015/SOM3/LSIF/SS/009 Agenda item: 6.8 APEC LSIF Blood Supply Chain Initiative Overview Purpose: Information Submitted by: LSIF PG Chair. Life Sciences Innovation Forum Special Session Cebu, Philippines

More information

Regional Update ASEAN PPWG

Regional Update ASEAN PPWG Regional Update ASEAN by Y uppadee JA V R O O N G R IT, Ph.D. Co-Chair of ACCSQ/, ASEAN Drug Control Division, ThaiFDA, Thailand The ICH-Global Cooperation Group Meeting Radissons SAS Brussels Hotel, Brussels,

More information

GUIDELINES ON PROCEDURAL ASPECTS FOR APPLICATIONS FOR MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS

GUIDELINES ON PROCEDURAL ASPECTS FOR APPLICATIONS FOR MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS Doc. No. TFDA/DMC/MCER/---- TANZANIA FOOD AND DRUGS AUTHORITY GUIDELINES ON PROCEDURAL ASPECTS FOR APPLICATIONS FOR MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS (Made under Section 52 (1) of the Tanzania

More information

Take a Course of Action.

Take a Course of Action. Take a Course of Action. When you choose RAPS Online University, you ll be on track to expand your regulatory knowledge and advance your career. Our comprehensive learning provides an immersive experience

More information

Version Number: 004 Controlled Document Sponsor: Controlled Document Lead:

Version Number: 004 Controlled Document Sponsor: Controlled Document Lead: Chief Investigators and Principal Investigators in Research Policy CONTROLLED DOCUMENT CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Policy Governance To set out the responsibilities of

More information

Work plan for GCP Inspectors Working Group for 2018

Work plan for GCP Inspectors Working Group for 2018 22 March 2018 EMA/87812 /2018 Committees and Inspections Chairperson: Ana Rodriguez The activities outlined in the work plan for 2018 have been agreed in view of preparation for the Agency s relocation

More information

ISO14155: 2011 Clinical investigation of medical devices for human subjects - Good Clinical Practice - ISO TC194 WG4 Madoka Murakami PMDA, Japan

ISO14155: 2011 Clinical investigation of medical devices for human subjects - Good Clinical Practice - ISO TC194 WG4 Madoka Murakami PMDA, Japan ISO14155: 2011 Clinical investigation of medical devices for human subjects - Good Clinical Practice - ISO TC194 WG4 Madoka Murakami PMDA, Japan What is GCP? Good Clinical Practice (GCP) is an international

More information

Global Location Trends: Asia-Pacific Facts & Figures

Global Location Trends: Asia-Pacific Facts & Figures IBM Global Business Services November 2012 Global Location Trends: Asia-Pacific Facts & Figures Table of Contents (1/4) Chapter 1: Leading sectors and activities for foreign investment 1.1 Top investing

More information

Points to Consider regarding the Notification and Publication of Package Insert Language

Points to Consider regarding the Notification and Publication of Package Insert Language Ministry of Health, Labour and Welfare Translated by Pharmaceuticals and Medical Devices Agency Safety Division, Pharmaceutical Safety and Environmental Health Office of Safety I Bureau This English version

More information

ICH STEERING COMMITTEE November 7-10, 2005, Chicago, USA SUMMARY

ICH STEERING COMMITTEE November 7-10, 2005, Chicago, USA SUMMARY ICH STEERING COMMITTEE November 7-10, 2005, Chicago, USA SUMMARY 1. Opening Discussions The ICH SC (Steering Commitee) meeting was chaired by FDA s Deputy Commissioner for International and Special Programs.

More information

Ensuring FDA Compliance of Foreign Clinical Trial Data. Kelsey Miller-Torchia

Ensuring FDA Compliance of Foreign Clinical Trial Data. Kelsey Miller-Torchia Ensuring FDA Compliance of Foreign Clinical Trial Data Kelsey Miller-Torchia 1 Background: Globalization of Clinical Trials In 2007 over 60% of pivotal studies submitted to CDER contained data from one

More information

WMA General Assembly, Reykjavik, Iceland Oct. 5, Valedictory Address. Yoshitake Yokokura, MD President World Medical Association

WMA General Assembly, Reykjavik, Iceland Oct. 5, Valedictory Address. Yoshitake Yokokura, MD President World Medical Association WMA General Assembly, Reykjavik, Iceland Oct. 5, 2018 Valedictory Address Yoshitake Yokokura, MD President World Medical Association Contributions of the World Medical Association WMA General Assembly

More information

ICH STEERING COMMITTEE October 24-29, 2009 St. Louis, MO, USA SUMMARY

ICH STEERING COMMITTEE October 24-29, 2009 St. Louis, MO, USA SUMMARY ICH STEERING COMMITTEE October 24-29, 2009 St. Louis, MO, USA SUMMARY 1. Opening Discussions The ICH Steering Committee (SC) meeting was chaired by the FDA. The meeting commenced with the provision of

More information

Update on FDA-EMA QbD Pilot

Update on FDA-EMA QbD Pilot Update on FDA-EMA QbD Pilot Presented by: Sharmista Chatterjee, PhD Branch Chief (Acting) Office of Process & Facility Office of Pharmaceutical Quality CDER, FDA Dolores Hernán, PhD Quality Office Specialized

More information

competitiveness of Vietnam s Engineering Workforce

competitiveness of Vietnam s Engineering Workforce competitiveness of Vietnam s Engineering Workforce Education Background.... p3 Professional Performance... p7 Compiled by TMA Solutions www.tmasolutions.com The leading software outsourcing company in

More information

International ICT data collection, dissemination and challenges

International ICT data collection, dissemination and challenges DATA - ICT Research Conference Royal College of Physicians Dublin, Ireland 12 March 2009 ICT data collection, dissemination and challenges Esperanza Magpantay Statistician Market Information and Statistics

More information

Seminar-Workshop to Promote the ASEAN Foundation in the CLMV Countries November, Phnom Penh, Cambodia December, Vientiane, Lao PDR

Seminar-Workshop to Promote the ASEAN Foundation in the CLMV Countries November, Phnom Penh, Cambodia December, Vientiane, Lao PDR Seminar-Workshop to Promote the ASEAN Foundation in the CLMV Countries 27-28 November, Phnom Penh, Cambodia 04-05 December, Vientiane, Lao PDR ASEAN Member Countries: Brunei Darussalam Cambodia Indonesia

More information

Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare

Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Notification number: 0427-1 April 27, 2015 To: Prefectural Health Department (Bureau) Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Notification

More information

Application from Health Technology Assessment international for admission into official relations with WHO

Application from Health Technology Assessment international for admission into official relations with WHO EXECUTIVE BOARD EB136/NGO/11 136th session 21 November 2014 Provisional agenda item 13.3 Application from Health Technology Assessment international for admission into official relations with WHO 1. Year

More information

Illustrative List of Possible APEC Actions to Support the APEC Leaders Growth Strategy

Illustrative List of Possible APEC Actions to Support the APEC Leaders Growth Strategy Illustrative List of Possible APEC to Support the APEC Leaders Growth Strategy We, the Senior Officials of Asia Pacific Economic Cooperation (APEC), have prepared the following illustrative list of ongoing

More information

CQA Consultant of HVCC, Hilversum, the Netherlands. Coaching of auditors on various levels is an on-going activity.

CQA Consultant of HVCC, Hilversum, the Netherlands. Coaching of auditors on various levels is an on-going activity. CURRICULUM VITAE Name : Vlaskamp First name : Johanna Maria (Hanny) Title : BSc. Address : Vuurvlindermeent 14 1218 GZ Hilversum The Netherlands Phone : +31 (0)6 54995411 (mobile) Nationality : Dutch EDUCATION

More information