Bioanalytical Method Validation in Japan and activities of the Japan Bioanalysis Forum
|
|
|
- Tracey Angel Chase
- 5 years ago
- Views:
Transcription
1 Bioanalytical Method Validation in Japan and activities of the Japan Bioanalysis Forum BMVJBF Noriko Katori, Ph.D. National Institute of Health Sciences
2 Today s Topics 1. Recent History of BMV in Japan 2. Activities of JBF 3. BMV Study Group
3 1. RECENT HISTORY OF BMV IN JAPAN
4 Bioanalysis Global Movement 1992 FDA AAPS FDAGuidance for Industry (Bioanalytical method validation) EBF was founded in 2006 at the initiative of 12 pharmaceutical companies FDA AAPSWhite Paper. ISR EMA Draft Guideline on Validation of Bioanalytical Methods CRO Global Bioanalysis Consortium (GBC) EMA Guideline on Validation of Bioanalytical Methods.
5 Regulatory Organization & Discussion groups in Japan Authorities! Ministry of Health, Labour and Welfare(MHLW )! Pharmaceuticals and Medical Devices Agency (PMDA )! National Institute of Health Sciences (NIHS ) Companies! Japan Pharmaceutical Manufacturers Association (JPMA )! Japan Generic Medicines Association (JGA)! Japan Association of Contract Laboratories for Safety Evaluation (JACL ) Scientific Group! Pharmaceutical Society of Japan (PSJ )! Japan Bioanalysis Forum (JBF )
6 The recent history around BMV in Japan! May, 2008, First workshop for ISR in Japan ( 56 AAPS/FDA White Paper Dr.Vishwanasan! , Discussion about BMV was held by pharmaceuticals and CROs,! Late of 2010, GBC (Global Bioanalysis Consortium) approached Japanese organizations and companies for recruiting their members.! Jan. 12, 2011, The First Asia Pacific Conference on Recent Issues in Regulated Bioanalysis (BMV,, China),! Mar. 30, 2011, Kick-off meeting of the JBF foundation members.
7 Foundation Members of JBF Representative! Kurokawa, Tatsuo (Prof., Keio Univ.) Academia! Haginaka, Jun (Prof., Mukogawa Women's Univ.)! Masujima, Tsutomu, (Prof., Hiroshima Univ.) Companies Pharmaceutical! Hara, Hisanori (Novartis Pharma AG, Switzerland)! Jinno, Fumihiro (Takeda Pharmaceutical Co., Ltd.)! Kobayashi, Nobuhiro, (DaiichiSankyo Co., Ltd.)! Kondo, Takahiro (Takeda Pharmaceutical Co., Ltd.)! Mabuchi, Masanari (Mitsubishi Tanabe Pharma Co.)! Matsumaru, Takehisa (Nippon Boehringer Ingelheim Co., Ltd)! Nakayaka, Akira (Ajinomoto Pharmaceuticals Co., Ltd.)! Ohtsu, Yoshiaki, (Astellas Pharma Inc.)! Osumi, Takahiko (Otsuka Pharmaceutical Co., Ltd.)! Tachiki, Hidehisa (Towa Pharmaceutical Co., Ltd.)! Yahata, Kenji (Sanofi-Aventis)! Yoneyama, Tomoki, (Takeda Pharmaceutical Co., Ltd.) CRO! Inoue, Noriko (JCL Bioassay Co., Ltd.)! Taniguchi, Masahiro (Sumika Analysis Service, Ltd.) Regulation! Katori, Noriko (National Institute of Health Sciences)
8 The recent history around BMV in Japan! Mar. 30, 2011, Kick-off meeting of the JBF foundation members,! 2nd quarter, 2011, A lot of JBF members applied for GBC-HT.! Aug. 10, 2011, The First JBF Symposium (Tokyo),! Oct. 6, 2011, Kick-off meeting of the BMV Study Group for Japanese BMV guideline,! Nov. 2011, EBF th Open Symposium (Barcelona), JBF was introduced by Mr. Shinobu Kudoh.! , Asian and Brazilian bioanalysis community are enthusiastic to have a regular communication with JBF. One of the options would be to establish "Asia-pacific Bioanalysis Communication Consortium.! Dec. 7, 2011, J-BMV Guideline items were listed-up by JBF,! Mar. 8, 2012, The Second JBF Symposium (Tokyo).
9 2. ACTIVITIES OF
10 JBF Related Symposia and Seminars after Establishment! Apr. 2011, 5 th Workshop on Recent Issues in Bioanalysis (Montreal), JBF establishment was officially preannounced by Dr. Noriko Katori.! Aug. 10, 2011, The First JBF Symposium (Tokyo),! Aug. 31- Sep. 2, 2011, JBF was introduced at regulated bioanalysis session in BMAS2011 (Tottori),! Nov. 1, 2011, JBF was introduced by Mr. Yoshiaki Ohtsu at the Waters Seminar (Tokyo),! Nov. 2011, JBF was introduced by Mr. Shinobu Kudoh at the EBF th Open Symposium (Barcelona),! Mar. 8, 2012, The Second JBF Symposium (Tokyo).
11 The first JBF Symposium (Tokyo, Aug.2011) " " " JCL " 1. BMVGBC CRO
12 BMAS2011 (Daisen, Tottori, Aug. 31- Sep. 2, 2011)! 24BMAS2011
13 Waters Seminar Waters JBF Christopher A. Evans Ph.D
14 EBF th Open Symposium Updates From The Globe! Shinobu Kudoh (Shimadzu for Japan Bioanalysis Forum) - Introducing the Japan Bioanalysis Forum (JBF) Home Contact Downloads Exhibition Organisation Posters Program Registration Slides Speakers Sponsoring Venue Directions Maps Reservations Shuttle Service Sitemap Follow EBF on: Slides PDF renditions of the powerpoint presentations given at EBF's 2011 open symposium can be viewed and downloaded from this page. NOTE: Authors/presenters who feel that a mistake has been made by the EBF, should contact the OSOC at bcn2011@europeanbioanalysisforum.eu Opening Philip Timmerman (for EBF) - Welcome to the conference Biomarker Validation Recommendation Philip Timmerman (on behalf of EBF) - Introduction to biomarker validation recommendation session Christian Herling (on behalf of EBF) - EBF reflections on biomarker validation Alexandre Avrameas (Novartis) - Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation Barry Jones (Advion) - LC/MS biomarker assay validation strategies using surrogate matrix and surrogate analyte approaches Richard Houghton (Quotient Bioresearch) - Challenges of validating small molecule LC-MS/MS biomarker methods John Chappell (ICON Development Solutions) - Biomarker Measurement- maximum information from limited volume How To Implement The EMA Guideline On Bioanalytical Method Validation Peter van Amsterdam (on behalf of EBF) - Introduction Olivier Le Blaye (afssaps) - The EMA Guideline on bioanalytical method validation Timothy Sangster (Charles River Laboratories) - EMA have our prayers been answered! Daniela Stoellner (Novartis) - New EMA guideline on method validation and how it translates into best practice for Ligand Binding Assays Graeme Smith (Huntingdon Life Sciences) - Partial Validation when is enough, enough? Morten Rohde (Lundbeck) - Matrix Effects in Bioanalysis, when established procedures become obsolete. Updates From The Globe Rafael Barrientos (Magabi for ACBio) - ANVISA guideline on bioanalytical method validation updates Shinobu Kudoh (Shimadzu for Japan Bioanalysis Forum) - Introducing the Japan Bioanalysis Forum (JBF)
15 Communication with Countries other than US and Europe! Asian and Brazilian bioanalysis community are enthusiastic to have a regular communication with JBF.! One of the options would be to establish "Asia-pacific Bioanalysis Communication Consortium.
16 Publications about JBF! PHARM TECH JAPAN, 27(10), 36 (2011)! JBF, 1, 52 (2012) PHARM TECH JAPAN, 28(3), 7-27 (2012)!! ( )!! JBF
17 Organization of JBF Representative Steering Committee Deputy Representatives Committees Task Force GBC-HT Support TF Guideline TF Other TF
18 Committees and Task Forces in JBF Committee Financial Committee Accounting Auditor Committee Webpage Committee Nominal Register Committee Event Executive Committee Public Relations Committee Task Force GBC-HT Guideline Membership Requirement GBC-HT TF 5 TF 5 TF 4
19 Steering Committee Members of JBF Representative! Kurokawa, Tatsuo, Ph.D. (Prof., Keio Univ.) Advisors! Haginaka, Jun, Ph.D. (Prof., Mukogawa Women's Univ.)! Masujima, Tsutomu,, Ph.D. (Prof., Hiroshima Univ.) GBC-SC! Shinobu Kudoh (Shimadzu Techno-Research, Inc.) Deputy Representative! Noriko Katori (National Institute of Health Sciences)! Masanari Mabuchi (Mitsubishi Tanabe Pharma Corporation)! Yoshiaki Ohtsu (Astellas Pharma Inc.) Members! Hisanori Hara (Novartis Pharma AG, Basel)! Harue Igarashi (GlaxoSmithKline K.K.)! Mami Imazato (Novartis Pharma K.K.)! Noriko Inoue, Ph.D. (JCL Bioassay Corporation)! Nobuhiro Kobayashi, Ph.D. (Daiichi Sankyo Co., Ltd.)! Takehisa Matsumaru, Ph.D. (Nippon Boehringer Ingelheim Co., Ltd.)! Yoshiyuki Minamide, Ph.D. (Shimadzu Techno-Research, Inc.)! Keiko Nakai (Mitsubishi Chemical Medience Corporation)! Akira Nakayama (Ajinomoto Pharmaceuticals Co., Ltd.)! Takahiko Osumi (Otsuka Pharmaceutical Co., Ltd.)! Hidehisa Tachiki, Ph.D. (Towa Pharmaceutical Co., Ltd. )! Kazutaka Togashi (Sumika Chemical Analysis Service, Ltd.)! Kenji Yahata (sanofi-aventis K.K.)! Katsuhiko Yamamoto (Kyowa Hakko Kirin Co., Ltd.)! Tomoki Yoneyama (Takeda Pharmaceutical Company Limited)
20 Steering Committee Members of JBF Representative! Kurokawa, Tatsuo, Ph.D. (Prof., Keio Univ.) Advisors! Haginaka, Jun, Ph.D. (Prof., Mukogawa Women's Univ.)! Masujima, Tsutomu,, Ph.D. (Prof., Hiroshima Univ.) GBC-SC! Shinobu Kudoh (Shimadzu Techno-Research, Inc.) Deputy Representatives! Noriko Katori (National Institute of Health Sciences)! Masanari Mabuchi (Mitsubishi Tanabe Pharma Corporation)! Yoshiaki Ohtsu (Astellas Pharma Inc.) GBC-HT members Members! Hisanori Hara (Novartis Pharma AG, Basel)! Harue Igarashi (GlaxoSmithKline K.K.)! Mami Imazato (Novartis Pharma K.K.)! Noriko Inoue, Ph.D. (JCL Bioassay Corporation)! Nobuhiro Kobayashi, Ph.D. (Daiichi Sankyo Co., Ltd.)! Takehisa Matsumaru, Ph.D. (Nippon Boehringer Ingelheim Co., Ltd.)! Yoshiyuki Minamide, Ph.D. (Shimadzu Techno-Research, Inc.)! Keiko Nakai (Mitsubishi Chemical Medience Corporation)! Akira Nakayama (Ajinomoto Pharmaceuticals Co., Ltd.)! Takahiko Osumi (Otsuka Pharmaceutical Co., Ltd.)! Hidehisa Tachiki, Ph.D. (Towa Pharmaceutical Co., Ltd. )! Kazutaka Togashi (Sumika Chemical Analysis Service, Ltd.)! Kenji Yahata (sanofi-aventis K.K.)! Katsuhiko Yamamoto (Kyowa Hakko Kirin Co., Ltd.)! Tomoki Yoneyama (Takeda Pharmaceutical Company Limited)
21 Relationship between JBF and other organizations APAC? Academy EBF Regulation GBC JF CVG Companies Global Domestic
22 Logotype of JBF! Shape & Color: One team of Japan! Tricolored: Industrial-Academic- Government Cooperation! Red: Strong will! White: Uprightness in science! Brown: Fertile ground in Bioanalysis Designed by Y. Ohtsu! Word arrange: Free from ill-precedents
23 3. BMV STUDY GROUP )
24 The recent history around BMV in Japan! Mar. 30, 2011, Kick-off meeting of the JBF foundation members,! 2nd quarter, 2011, A lot of JBF members applied for GBC-HT.! Aug. 10, 2011, The First JBF Symposium (Tokyo),! Oct. 6, 2011, Kick-off meeting of the BMV Study Group for Japanese BMV guideline,! Nov. 2011, EBF th Open Symposium (Barcelona), JBF was introduced by Mr. Shinobu Kudoh.! , Asian and Brazilian bioanalysis community are enthusiastic to have a regular communication with JBF. One of the options would be to establish "Asia-pacific Bioanalysis Communication Consortium.! Dec. 7, 2011, J-BMV Guideline items were listed-up by JBF,! Mar. 8, 2012, The Second JBF Symposium (Tokyo).
25 BMV Study Group!!!
26 The members of the BMV Study Group NIHS! Yasuo Ohno, Ph.D. (Chief)! Haruhiro Okuda, Ph.D.! Nana Kawasaki, Ph.D.! Noriko Katori, Ph.D. MHLW! Toshinari Mitsuoka PMDA! Reiko Sato, Ph.D.! Daisuke Iwata JPMA! Akira Nakayaka (Ajinomoto Pharmaceuticals Co., Ltd.)! Masataka Katashima, Ph.D. (Astellas Pharma Inc.) JGA! Hidehisa Tachiki, Ph.D. (Towa Pharmaceutical Co., Ltd.) JACL! Noriko Inoue, Ph.D. (JCL Bioassay Co., Ltd.)! Kazutaka Togashi (Sumika Analysis Service, Ltd.)
27 Differences in Mission! BMV Study Group Helping to make Japanese Guidelines for BMV Spreading the concept of BMV to regulation sides in Japan Making basic consensus between organizations around BMV! JBF Facilitating science driven discussions on bioanalysis Helping setting in Japan BMV by providing scientific rationale and consensus amongst Japanese bioanalysts To be a partner representing Japanese bioanalytical community for global harmonization
28 Relationship between JBF and BMV Study Group Academy EBF Regulation GBC JBF Draft of BMV Guideline BMV Study Group CVG Companies Global Domestic
29 Schedule! Draft BMV guideline (TF version, for small molecule) 29 February 2012! 6 th Workshop on Recent Issues in Bioanalysis (San Antonio) Japanese Guideline will be introduced by Mr. Mitsuoka (MHLW) March 2012! Draft BMV guideline (JBF version, for small molecule) 31 March 2012! Comment from JPMA, JGA,JACL, and others! Q&A (BMV guideline for small molecule)! 3 rd JBF Symposium (Tokyo)! Draft guideline (large molecule) 2nd quarter, 2012 (scheduled) May 2012 (scheduled) 8 August 2012 end of 2012 (scheduled)
30 3rd JBF Symposium (Tokyo)! Date: Aug. 8, 2012! Place: Tokyo (Keio University)!
31 Thank you!
Regulated bioanalysis status in Japan and notable points of the draft Japanese guideline
Regulated bioanalysis status in Japan and notable points of the draft Japanese guideline EBF 5th Open Meeting Old Battles, New Horizons, November, 16, 2012, Barcelona Noriko Katori, PhD National Institute
JBF Annual Report FY2014
JBF Annual Report FY2014 (From 1 st April 2014 to 31 st March 2015) 1. Overview It has been passed three years and a half since the establishment of Japan Bioanalysis Forum (JBF). We aim to facilitate
The 6 th JBF Symposium Program Challenge of Regulated Bioanalysis
25 th February (Wed.) The 6 th JBF Symposium Program Challenge of Regulated Bioanalysis Date: 25 th -26 th February 2015 Venue: Tower Hall Funabori, Tokyo, Japan (Oral presentation:small Hall on 5F, Poster
The 6 th JBF Symposium Program (draft) Challenge of Regulated Bioanalysis
The 6 th JBF Symposium Program (draft) Challenge of Regulated Bioanalysis Date: 25 th -26 th February 2015 Venue: Tower Hall Funabori, Tokyo, Japan (Oral presentation:small Hall on 5F, Poster session :
GLOBAL BIOANALYSIS CONSORTIUM
GLOBAL BIOANALYSIS CONSORTIUM Regulated Bioanalysis - A Proposed Global Harmonization Process Presented by Peter van Amsterdam for GBC SoFAQ International Seminar "Quality Assurance and Electronic Data"
Current Developments in Guidance for Regulatory Bioanalysis
Current Developments in Guidance for Regulatory Bioanalysis Dr Gerry McGuire Resolution Analytical Consultancy Ltd Edinburgh, Scotland UK gerry@resolutioneurope.com 1st MENA Regulatory Conference on Bioequivalence,
GLOBAL BIOANALYSIS CONSORTIUM
GLOBAL BIOANALYSIS CONSORTIUM Regulated Bioanalysis - A Proposed Global HarmonizaDon Process presented by Peter Van Amsterdam on behalf of GBC at 3 rd EBF Focus Mee=ng June 13 th 2012 - Brussels - BELGIUM
AAPS Views on Bioanalytical Method Validation Harmonization (on Behalf of AAPS Bioanalytical Community)
AAPS Views on Bioanalytical Method Validation Harmonization (on Behalf of AAPS Bioanalytical Community) Faye Vazvaei, Roche Innovation Center New York The 8th JBF Meeting, 8-9 February 2017 Background
Updates on the Progress of the. Harmonization Teams (GBC-HT) for Small & Large Molecules
Updates on the Progress of the Global BioanalyticalConsortium Harmonization Teams (GBC-HT) for Small & Large Molecules Dr. Fabio Garofolo for GBC AAPS Annual Meeting October 2011 - Washington DC -USA Agenda
The regulatory landscape Stephen White on behalf of the EBF
The regulatory landscape Stephen White on behalf of the EBF http://www.europeanbioanalysisforum.eu Overview 1. MIST and DDI Guideline 2. Regulatory landscape for BA 3. Tiered Approach on BA of metabolites
Update on ANVISA Bioanalytical Method Validation (BMV) Guideline
Av. Andrade Neves, 295 - Sala 184 - Ed. Torre São Paulo - Centro - Campinas/SP CEP: 13013-160 - F:(+55-19)3231 8146 acbio@acbio.org.br - www.acbio.org.br Update on ANVISA Bioanalytical Method Validation
AAPS/PSCW 2010 APQ Open Forum
AAPS/PSCW 2010 APQ Open Forum Harmonization of Global Bioanalytical Regulations Scientific Perspective and Update on Developments 18 November 2010 Steve Lowes, Ph.D. Advion BioServices Inc Ithaca, NY Introduction
Standardised Lab Manual for bioanalytical support in clinical studies : Introducing the harmonised Lab Manual. Introduction to the Workshop
Standardised Lab Manual for bioanalytical support in clinical studies : Introducing the harmonised Lab Manual Introduction to the Workshop Philip Timmerman (for EBF) 05 February 2014 NH Sablon Hotel, Brussels
GLOBAL BIOANALYSIS CONSORTIUM
GLOBAL BIOANALYSIS CONSORTIUM Scope and Regulations Harmonization Team: A1 (Work in Progress) John Smeraglia on behalf of the HT-A1 A1: Scope and regulations Team members: Team lead Region Expertise Surendra
Global Pediatric Development: We Are Making Progress. PMDA Perspective. Junko Sato, PhD PMDA
Global Pediatric Development: We Are Making Progress PMDA Perspective Junko Sato, PhD PMDA Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter
PMDA Considerations for Outcome Assessments
PMDA Considerations for Outcome Assessments Keiju Motohashi Office of New Drug II Pharmaceuticals and Medical Devices Agency/ The University of Tokyo Hospital Disclaimer The views and opinions expressed
Global Harmonization: Latin America Overview and Perspective
Av. Andrade Neves, 295 - Sala 184 - Ed. Torre São Paulo - Centro - Campinas/SP CEP: 13013-160 - F:(+55-19)3231 8146 secretaria@acbio.org.br - www.acbio.org.br Global Harmonization: Latin America Overview
Peking University Asia Pacific Economic Cooperation Regulatory Sciences Center of Excellence APEC CENTER OF EXCELLENCE PILOT WORKSHOP
Peking University Asia Pacific Economic Cooperation Regulatory Sciences Center of Excellence APEC CENTER OF EXCELLENCE PILOT WORKSHOP MULTI-REGIONAL CLINICAL TRIALS AND INCORPORATING GCP-RELATED CONSIDERATIONS
EBF Tiered approach final. Validation criteria. Philip Timmerman, on behalf of the EBF 8 th EBF Open Symposium
EBF Tiered approach final recommendation of Scientific Validation criteria Philip Timmerman, on behalf of the EBF 8 th EBF Open Symposium - 2015 The problem statement 1990 CC-I 2001 FDA Further refinement,
CANCER HAZARD IDENTIFICATION STRATEGIES PROJECT COMMITTEE
CANCER HAZARD IDENTIFICATION STRATEGIES PROJECT COMMITTEE Mission The mission of the HESI Cancer Hazard Identification Strategies (CHIS) Project Committee was to consider new strategies that can offer
Gender Statistics Programme of the United Nations Economic Commission for Europe
United Nations Statistical Commission 7 February 2011 Forty-second session New York, 22-25 February 2011 Room paper Item 3b of the provisional agenda Available in English only Programme review: gender
Review Report. (11) Olanzapine Fine Granules 1% "DSEP" (14) Olanzapine OD Tablets 10 mg "DSEP" (17) Olanzapine Tablets 10 mg "Nichi-Iko"
Review Report November 13, 2017 Pharmaceuticals and Medical Devices Agency The following are the results of the review of the following pharmaceutical products submitted for marketing approval conducted
5th AOHUPO Congress. 14th ADNAT Convention & 1 st PSI Conference. February 2010
5th AOHUPO Congress Proteome-SKY China State Key Laboratory of Proteomics has been officially approved by central government 14th ADNAT Convention & 1 st PSI Conference February 2010 Hyderabad, India INSIDE
Clinical trial consultation system (utility and successful cases from company s point of view)
Clinical trial consultation system (utility and successful cases from company s point of view) 3 rd China-Japan Symposium on Drug Development March 22, 2012 Japan Pharmaceutical Manufacturers Association
WCO Strategic Initiatives for Trade Facilitation
International Seminar on Trade Facilitation in North East Asia 13 December 2016 Incheon, Republic of Korea WCO Strategic Initiatives for Trade Facilitation Ms. Alpha WONG World Customs Organization (WCO)
Test Article Analyses in Compliance with Good Laboratory Practice in Japan: Circumstances and Changes
Test Article Analyses in Compliance with Good Laboratory Practice in Japan: Circumstances and Changes Harumi Namiki 1, *, Tetsuya Shigeta 2, Yoshitaka Ino 3, Kanzo Kimura 4, Katsutoshi Inaba 5, Sachio
European Patients Academy on Therapeutic Innovation
European Patients Academy on Therapeutic Innovation http://www.patientsacademy.eu info@patientsacademy.eu The project is receiving support from the Innovative Medicines Initiative Joint Undertaking under
SEVENTH INTERNATIONAL WORKSHOP ON DOSIMETRY FOR RADIATION PROCESSING
INTRODUCTION ASTM Subcommittee E10.01, Radiation Processing: Dosimetry and Applications, is proud to present the seventh edition of our International Workshop on Dosimetry for Radiation Processing. This
3/31/2009. Phase 0 Microdosing Studies with Renin Inhibitors. Disclaimer. Overview of Today s Presentation. J. Chris Jensen Consultant
Phase 0 Microdosing Studies with Renin Inhibitors J. Chris Jensen Consultant Speedel Holding Ltd. Basel, Switzerland Disclaimer The views and opinions expressed in the following PowerPoint slides are those
THE MARKET-LEADING RESOURCE FOR THE GLOBAL BIOANALYTICAL COMMUNITY BIOANALYSIS ZONE 2018 MEDIA PACK
THE MARKET-LEADING RESOURCE FOR THE GLOBAL BIOANALYTICAL COMMUNITY BIOANALYSIS ZONE 2018 MEDIA PACK Sarah Mayes: s.mayes@future-science.com Dionne Murray: d.murray@future-science.com +44 (0)20 8371 6090
PPD S EXPERT HEMATOLOGY AND ONCOLOGY TEAM
HEMATOLOGY ONCOLOGY PPD S EXPERT HEMATOLOGY AND ONCOLOGY TEAM COMMITTED TO ADVANCING DRUG DEVELOPMENT IN ONCOLOGY $ MARKETPLACE COMPLEXITIES increasingly competitive marketplace and rising cost pressures
EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON DISINTEGRATION TEST GENERAL CHAPTER Q4B ANNEX 5(R1)
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL
Pierre-Marie GUITTON Next Generation Nicotine Delivery London June, 2017
Contribution To Develop Standards For The Global Vapour Industry Pierre-Marie GUITTON Next Generation Nicotine Delivery London - 14-15 June, 2017 Outline Introduction to CORESTA CORESTA activities Process
Biomarker classification: a philosophical introduction.
Biomarker classification: a philosophical introduction. Philip Timmerman, on behalf of the EBF biomarker team (TT-14) 16 November 2011, Barcelona, Spain Background A few no-brainers to start the conference
UK - CGCM UKCGCM. Chairman Professor Ian Sutherland. Dr Jin Xu. 1) Nottingham University
UK - CGCM Chairman Professor Ian Sutherland Co-Chair Chair Dr Tai-Ping Fan Co-chair Dr Jin Xu 1) Nottingham University UKCGCM Kenneth Muir now moved to Warwick University 2) Oxford University Gerry Bodeker
Influenza Vaccination Market Research Report Global Forecast till 2023
Report Information More information from: https://www.marketresearchfuture.com/reports/1621 Influenza Vaccination Market Research Report Global Forecast till 2023 Report / Search Code: MRFR/HC/1090-HCRR
TABLE OF CONTENTS 1 Table of Contents 2 Introduction 3 Key Marketed Products
TABLE OF CONTENTS 1 Table of Contents 1.1 List of Tables 1.2 List of Figures 2 Introduction 2.1 Epidemiology 2.2 Symptoms 2.3 Etiology 2.4 Pathophysiology 2.5 Co-morbidities and Complications 2.6 Classification
PEN-International Focusing on Deaf Education in Pacific Rim
Topics for Today s Presentation PEN-International Focusing on Deaf Education in Pacific Rim E. William Clymer James J. DeCaro PEN-International NTID, USA http://www.pen.ntid.rit.edu/pdf/nadc04.pdf RIT/NTID
Japanese Regulatory and Industry perspective. Kazuhiro Shimomura, Ph.D. Medicinal Safety Research Laboratories Daiichi Sankyo Co., Ltd.
Japanese Regulatory and Industry perspective Kazuhiro Shimomura, Ph.D. Medicinal Safety Research Laboratories Daiichi Sankyo Co., Ltd. 1 Activities for Juvenile Study in Japan 2004.2 Repro. Tox. Tokyo
World Renderers Organisation Report
World Renderers Organisation Report Tim Juzefowicz, 1st vice President NRA 81 st National Convention Palm Springs October 22nd 2014 WRO Representing the Animal by-product processing Sector around the world
Bioequivalence Requirements: USA and EU
Bioequivalence Requirements: USA and EU Dr. Nicholas Cappuccino Chair, IGPA Science Committee Global Head of Quality, Dr. Reddy s Laboratories Ltd. 15 th Annual IGPA Conference Kyoto, Japan December 6,
t 14,081 FOLLOWERS f 28,855 FANS l 2,879 FOLLOWERS
7 OVERVIEW 8,8 MEMBERS REPRESENTING 4 COUNTRIES,68,7 UNIQUE VISITS TO ASN WEBSITE,96 KIDNEY WEEK PARTICIPANTS IMPACT FACTORS 8.97 JASN 9,78 KIDNEY NEWS CIRCULATION NONMEMBER - 9,8 4.78 CJASN Latest available
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
Assay Cross Validation
Assay Cross Validation Recent experiences in transferring bioanalytical assays from sponsor to CRO partners and between CROs Stephen White EBF Open Symposium Barcelona 20 th Nov 2013 Assay Cross Validation
Hyderabad, India Delegates. April 27, Tentative program A comprehensive Bioanalysis conclave. Key notes.
INTERNATIONAL CONFERENCE &EXHIBITION Tentative program A comprehensive Bioanalysis conclave 7+ Key notes 50+ Poster presentations 100+ Delegates 2 + Panel Discussions April 27, 2018 Hyderabad, India Invitation
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
Volume Issue Issue Date Number of Pages Actually Mailed June Jul August Jan April Jan-16
SIGAda Name and Mission: SIGAda: SIGAda Ada Programming Language The ACM Special Interest Group on the Ada Programming Language provides a forum on all aspects of the Ada language and technologies, including
Introduction. About the Lupus Academy
Content Introduction Past Activities Barcelona 2012 Buenos Aires 2013 Further Development of the Lupus Academy Berlin 2014 Philippines (APLAR) 2014 Educational support programme Budgets 2 Introduction
Decision Making Across the Lifespan
40th Annual Meeting EXHIBIT AND SPONSORSHIP October 14-17, 2018 Fairmont The Queen Elizabeth Montreal, QC, Canada Decision Making Across the Lifespan 2018 OCTOBER 14th - 17th SMDM 390 Amwell Road, Suite
OATech+ Network: Using Technology to work towards improving Patient Outcomes. Leanne Sawle
OATech+ Network: Using Technology to work towards improving Patient Outcomes Leanne Sawle Overview Osteoarthritis (OA) affects 8.75 million people in the UK (Mobasheri & Batt 2016) Places a considerable
Welcome. International Society for CNS Clinical Trials and Methodology
Welcome International Society for CNS Clinical Trials and Methodology 2018 Autumn Conference Advances in Clinical Trial Technology: Impact on Methodology and Signal Detection 15-16 October 2018 Marina
Sample logistics: problems and solutions in multi-center clinical trials Proposed Generic EBF Lab Manual
Sample logistics: problems and solutions in multi-center clinical trials Proposed Generic EBF Lab Manual Rebecca Sleigh on behalf of TT-12 6 th EBF Open Symposium 20-22 November 2013 Hesperia Tower, Barcelona
Boehringer Ingelheim Biopharmaceuticals in China. Your Reliable Contract Manufacturing Solution Provider
Boehringer Ingelheim Biopharmaceuticals in China Your Reliable Contract Manufacturing Solution Provider Dr. Bin Wang, Dr. Axel Schleyer Boehringer Ingelheim Biopharmaceuticals (China) Co., Ltd. Contact:
Overview of the Radiation Exposure Doses of the Workers at Fukushima Daiichi Nuclear Power Station
Click here for the corrections made < Reference > December 3, 212 Tokyo Electric Power Company Overview of the Radiation Exposure Doses of the Workers at Fukushima Daiichi Nuclear Power Station * As of
White Paper. For reprint orders, please contact
White Paper For reprint orders, please contact reprints@future-science.com The European Bioanalysis Forum community s evaluation, interpretation and implementation of the European Medicines Agency guideline
PEN-International in Japan. Naoki Ohnuma, MasahikoSuto Tsukuba College of Technology
1 PEN-International in Japan Naoki Ohnuma, MasahikoSuto Tsukuba College of Technology 2 Tsukuba College of Technology in Japan 150 Deaf and 120 Blind students Established 1988, as 3 year program 2005 Oct.1
Lions Gate Secondary Wastewater Treatment Plant
Lions Gate Secondary Wastewater Treatment Plant Lions Gate Public Advisory Committee June 26, 2012 Orbit 6241100 Lions Gate Secondary Wastewater Treatment Plant Building a working relationship with the
ICH M4E(R2): Revised Guideline on Common Technical Document -- Efficacy
ICH M4E(R2): Revised Guideline on Common Technical Document -- Efficacy International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 1 Background Regulatory authorities
GLP Update and Hot Topics
GLP Update and Hot Topics RQA Annual Conference Mark Goodwin 9 Nov 2016 Introduction International GLP Updates OECD including MAD Agreement EC/ EMA US FDA & US EPA UK GLP Update MHRA MHRA GLP Deficiencies
Indian Pharmacopoeia Commission
Indian Pharmacopoeia Commission JP 130 th Anniversary Symposium Tokyo, Japan 15 th Sept, 2016 Dr.G.N.Singh Secretary cum Scientific Director, Overview Indian Pharmaceutical Industry Pharmacopoeia and NFI
THE CORPORATE REPUTATION OF PHARMA 2015 THE PERSPECTIVE OF 139 PATIENT GROUPS with an interest in DIABETES
THE CORPORATE REPUTATION OF PHARMA 2015 THE PERSPECTIVE OF 139 PATIENT GROUPS with an interest in DIABETES PUBLISHED AUGUST 2016 There is growing distrust of pharma in light of several recent and dramatic
Health Equity Workgroup. January 18, 2018
Health Equity Workgroup January 18, 2018 Health Equity Workgroup Co-Chairs Fleda Mask Jackson, PhD Founder, Save 100 Babies President and CEO, Majaica, LLC University Affiliate, Columbia University Arthur
The Data Collection on Adverse events of Anti-HIV Drugs
Dias 1 The Data Collection on Adverse events of Anti-HIV Drugs Ole Kirk, University of Copenhagen Denmark Dias 2 The Need for D:A:D February 1999, EMEA/Committee for Medicinal Products for Human Use (CHMP)
Public Health Emergencies Preparedness Planning in the Aviation Sector: The CAPSCA - Asia Pacific Story
Public Health Emergencies Preparedness Planning in the Aviation Sector: The CAPSCA - Asia Pacific Story 4 th CAPSCA Global Coordination Meeting & 3 rd CAPSCA Europe Meeting Bern, Switzerland; 18 to 21
Singapore s Progress on GLP and MAD
2010/SOM1/CD/WKSP/025 Agenda Item: Afternoon Session I Singapore s Progress on GLP and MAD Submitted by: Singapore Case Study Workshop on the Chemicals Sector - From Principles to Practice Hiroshima, Japan
MEETING PROSPECTUS. International Workshop on NASH Biomarkers
International Workshop on NASH Biomarkers 2018 18-19 May 2018 Washington, D.C., USA MEETING PROSPECTUS www.expertmedicaleducation.com www.expertmedicalevents.com ADVANCING HEALTH GLOBALLY THROUGH INNOVATIVE
GLOBAL AND REGIONAL SITUATION OF AVIAN INFLUENZA
GLOBAL AND REGIONAL SITUATION OF AVIAN INFLUENZA Dr Gounalan Pavade OIE Regional Expert Group Meeting for the Control of Avian Influenza in Asia Sapporo, Japan 3-5 October 2017 1 Avian influenza Outbreaks
Mackenzie Valley Review Board EA Whatì Public Hearing. November 15, 2017 (Day 1)
Mackenzie Valley Review Board EA1617-01 Whatì Public Hearing November 15, 2017 (Day 1) Outline Project History & Purpose Project Description Design & Procurement Overview of Environmental Assessment Key
in the ICH Regions Table of Content Annexes to Guideline and 3. Why is Q4B necessary? Q4B Annexes? for Human Use
Frequently Asked Questions Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions The Q4B Expert Working Group developed a set of frequently asked questions to help users
For reprint orders, please contact Commentary
For reprint orders, please contact reprints@future-science.com 7th GCC Insights: incurred samples use; fitfor-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix
Points to Consider CPhI Japan Briefing Session on Pharmaceutical Regulations in Japan
2013 CPhI Japan Briefing Session on Pharmaceutical Regulations in Japan The Master File System and Points to Consider Kentaro Hashimoto, Master File Management Group, Division of Pharmacopoeia and Standards
Progress Report of the activities of the Working Group «Hypertension and the Kidney»
Progress Report of the activities of the Working Group «Hypertension and the Kidney» 2017-2018 Contents Members... 2 WG meetings... 2 Fibromuscular Dysplasia (FMD)... 5 Hypertension in dialysis... 6 Hypertension
Kenneth Gordon, 1 Kim A. Papp, 2 Kara Creamer Rice, 3 Mona Trivedi, 3 David H. Collier, 3 Greg Kricorian 3
American Academy of Dermatology 75 th Annual Meeting, Orlando, FL; March 3 7, 2017 Poster 4563 Novel Evaluation of Psoriasis Area and Severity Index (PASI) Data: Distribution of PASI Improvements in a
Challenges in Performing a Scientifically Meaningful Lipemic Plasma Test in Bioanalytical Method Validation
Challenges in Performing a Scientifically Meaningful Lipemic Plasma Test in Bioanalytical Method Validation Laurence Mayrand-Provencher, Milton Furtado, Jean- Nicholas Mess, Josée Michon, Annik Bergeron,
Preliminary Programme Version 9 September 2010 EFGCP Children s Medicines Working Party 6th Annual Conference & DIA Paediatric SIAC 4th Forum Current & Future Perspectives for Paediatric Medicines: Visions,
Timetable detailed schedule Term 3 and
Term 3 and 4 2017 Welcome to the Term 3 and 4 2017 timetable schedule This timetable forms a detailed schedule to the Academic Calendar Timetable 2017-2019 which can be found on our website. Its purpose
Final Programme EFGCP Children s Medicines Working Party 6th Annual Conference & DIA Paediatric SIAC 4th Forum Current & Future Perspectives for Paediatric Medicines: Visions, Daily Challenges, Ways Forward
2019 PARTNER PROSPECTUS
2019 PARTNER PROSPECTUS ASIA Mission 1. Promote and establish standards of excellence for all aspects of health care of individuals with spinal cord injury from onset throughout life 2. Educate members,
IAEA Activities in the Area of Fast Neutron Systems
Worrksshop on Teecchnollogy aand Applliiccaattiionss off Acccceelleerraattorr Drriiveen Sysstteemss ((ADS)) 17 -- 28 Occttobeerr 2005 1677/10 IAEA Activities in the Area of Fast Neutron Systems A. Stanculescu
SCHOLARLY ACTIVITY STEERING COMMITTEE MEETING (SASC) Friday March 28, 2014 at 9:00 am Meeting Room B144 M I N U T E S
SCHOLARLY ACTIVITY STEERING COMMITTEE MEETING (SASC) Friday March 28, 2014 at 9:00 am Meeting Room B144 M I N U T E S Present: Regrets: Leelah Dawson, Janet Douglas, John Falcus, Margaret Heldman (Chair),
Novo Nordisk Pharma AG Methodology Note - reporting year 2016 ( Methodology )
Novo Nordisk Pharma AG Methodology Note - reporting year 2016 ( Methodology ) Table of contents Preamble... 0 1. General Summary... 1 2. Terminology and Definitions... 2 3. Change log... 8 Preamble Novo
Education. Current Activities
Nirali Mehta, M.Sc., M.Phil. Founder & Consultant Biostatistician Ahmedabad, Gujarat, India. M +91 9377060504 E nirali.mehta@pharma-stats.in W www.pharma-stats.in Education 1998-2001 Bachelor of Science
UNSD Questionnaire on National Gender Statistics Programs and Activities *
UNITED NATIONS SECRETARIAT ESA/STAT/AC.122/18 Department of Economic and Social Affairs December 2006 Statistics Division English only Inter-Agency and Expert Group Meeting on the Development of Gender
HBSN Annual Report (2016) Editorial Office
HBSN Annual Report (2016) Editorial Office editor@thehbsn.org Basic Information Open-access Peer-reviewed Published Bi-monthly 2012: Launched in Dec. 2014: Indexed in PubMed/PMC 2016: Indexed in ESCI New
Asia Pacific Medical Publications: NAVIGATING OUR FUTURE
Asia Pacific Medical Publications: NAVIGATING OUR FUTURE It is our pleasure to welcome you to the second Asia Pacific Meeting of ISMPP. Building on the success of the inaugural meeting that focused on
ISPD PRESIDENT S MESSAGE - SPRING, 2016
ISPD PRESIDENT S MESSAGE - SPRING, 2016 Philip K.T. LI, ISPD President Dear all Members, Colleagues and Supporters of ISPD, Happy New Year 2016 to all of you. I want to update you on the progress of the
Welcome and PRO Consortium Update
Welcome and PRO Consortium Update Stephen Joel Coons, PhD Executive Director, PRO Consortium FIFTH ANNUAL PATIENT-REPORTED OUTCOME (PRO) CONSORTIUM WORKSHOP April 29-30, 2014 Silver Spring, MD Co-sponsored
Liver Forum Cirrhosis Working Group Arun J. Sanyal
Liver Forum Cirrhosis Working Group Arun J. Sanyal Z Reno Vlahcevic Professor of Medicine VCU School of Medicine Richmond, VA 2 Liver Forum 8 DRUG DEVELOPMENT PATHWAYS Regular approval pathway: based on
NOAC trials for AF: A review
NOAC trials for AF: A review Chern-En Chiang, MD, PhD, FACC, FESC General Clinical Research Center Division of Cardiology Taipei Veterans General Hospital National Yang-Ming University Taipei, Taiwan Presenter
White Paper Timmerman, White, Cobb, de Vries, Thomas & van Baar
White Paper Mini Focus Issue: Dried blood spots For reprint orders, please contact reprints@future-science.com Update of the EBF recommendation for the use of DBS in regulated bioana lysis integrating
Update on the dengue situation in the Western Pacific Region
Dengue Situation Update 448 23 September 214 Update on the dengue situation in the Western Pacific Region Northern Hemisphere Japan As of September 22, Ministry of Health, Labour and Welfare (MHLW), Japan,
Boehringer Ingelheim BioXcellence. Producing Value. Global Contract Manufacturing Excellence
Boehringer Ingelheim BioXcellence Producing Value Global Contract Manufacturing Excellence Your World Class Contract Manufacturer Boehringer Ingelheim BioXcellence Producing Value Boehringer Ingelheim
U.S. Flue-Cured Tobacco Situation & Outlook February 6, 2015
U.S. Flue-Cured Tobacco Situation & Outlook February 6, 2015 Dr. Blake Brown Hugh C. Kiger Professor Agriculture & Resource Economics College of Agriculture & Life Sciences How much are contracted pounds
Where Sites, Sponsors & CROs Partner for Success
Where Sites, Sponsors & CROs Partner for Success October 8-11, 2015 Amelia Island, FL The Global Site Solutions Summit brings together research site executives and industry leaders for powerful collaboration
The Role of EPAG in Standards and Regulatory Guidance Development
The Role of EPAG in Standards and Regulatory Guidance Development Jolyon P. Mitchell on behalf of EPAG Session 4: The Remit, Activities and Achievements of The European Pharmaceutical Aerosols Group 1
Global Healthcare User Group GS1 HUG ~ Berlin ~ January 2007
Germany Global Healthcare User Group GS1 HUG ~ Berlin ~ January 2007 Communication & Coordination Support Team Rich Hollander - Pfizer & Jim Willmott - Smiths Medical Ulrike Kreysa, Nadège Mullier, Nora
Future of Diabetes Research in Europe JDRF Perspective
Future of Diabetes Research in Europe JDRF Perspective IMI-JDRF Diabetes Patient Meeting 20 May 2014 Brussels, Belgium Olivier ARNAUD, Pharm D JDRF European Research Director oarnaud@jdrf.org Future of
Towards a Sustainable Global Infrastructure for Medical Countermeasures
Towards a Sustainable Global Infrastructure for Medical Countermeasures Institute of Medicine The Public Health Emergency Medical Countermeasures Enterprise: Innovative Strategies to Enhance Products from
Vaccine Clinical. Cancer. Group. Working. Trial. Final Workshop, 10 November 2005
Cancer Vaccine Clinical Trial Working Group Final Workshop, 10 November 2005 CVCTWG Issues Cancer vaccines have unique developmental challenges. Some potential solutions exist. Not all potential solutions
Bioanalytical Method Development and Validation: from the USFDA 2001 to the USFDA 2018 Guidance for Industry
Journal of Applied Bioanalysis http://dx.doi.org/10.17145/jab.18.010 COMMENTARY Bioanalytical Method Development and Validation: from the USFDA 2001 to the USFDA 2018 Guidance for Industry Roland J.W.