The new Pharmacovigilance legislation and implementation planning
|
|
- Jasmine Atkinson
- 5 years ago
- Views:
Transcription
1 The new Pharmacovigilance legislation and implementation planning Second Stakeholders meeting 17 June 2011 European Medicines Agency, London, UK Presented by: Franck Diafouka Manager, Pharmacovigilance and Risk Management sector An agency of the European Union
2 Agenda 1. Implementing the new legislation: Governance - EMA; -EU Network; - Working methodology; - Reporting timelines; - Stakeholders liaison. 2. Implementing the new legislation: Deliverables - Implementation phasing plan; - EMA/Member States technical contribution to EC draft Implementing Measures and s; 1
3 Governance EMA (1/5) EMA 00305: Cross-Agency Task Force Established Jan 2010 Monthly meetings Initial mandate: Assess in detail the impact of the new legislative proposal on the European Medicines Agency activities or operations Deliver on time the measures necessary to implement the new legislation 2
4 1. Governance EU Network (2/5) Oversight Committee (ERMS-FG) 6 EMA/MSs Teams Coordination Group ICT Group EMA/MSs Team 1 -Audit/ Inspections EMA/MSs Team 2 PSURs EMA/MSs Team 3 ADR reporting /Additional Monitoring/ -Signals EMA/MSs Team 4 -RMP/ PASS/PAES -Effectiveness of risk Minimisation EMA/MSs Team 5 -Committees/ Referrals EMA/MSs Team 6 -Communication/ Transparency MA Task- Force 12 EMA Subproject Teams PSUR Product Info. PASS/PAES EV/ADR rep. Committees Referrals Fees Com./Transp Lit. monit/ Signal detect. Insp./PhV sy. RMS PhV audits 3
5 4 1. Governance working methodology (3/5) Subproject Teams Teams Issue Log Actions Tracking Status Report Coordination Group Tracking Actions Oversight ERMS FG Drafted Drafted/ Agreed Adopted Adopted Issue Log Status Report Status Report Heads of Medicines Agencies Informed Subproject Teams Teams Issue Log Actions Tracking Status Report Coordination Group Tracking Actions Oversight ERMS FG Drafted Drafted/ Agreed Adopted Adopted Issue Log Status Report Status Report Heads of Medicines Agencies Informed
6 1. Governance Reporting timelines (4/5) Friday 2 weeks before CHMP Subproject Teams submit Status Report 5 Coord. Group submits Status Report to ERMS FG Wednesday Week after CHMP Coord. Group meets to review Status Reports Wednesday CHMP week Friday Week before CHMP Teams submit Status Report
7 1. Governance - Stakeholders liaison and consultation (5/5) Stakeholders meetings involving EMA, Member States, EC, Industry, Patients and Healthcare Professionals representatives: 15th April 2011 (positive feedback) 17th June 2011 More later in the year... Formal public consultations by EC and EMA 6
8 2. What will be delivered?(1/6) Hierarchy of rules Deliverables -Regulation(EC) 1235/2010 -Directive2010/84/EC EC Implementing Measures = Commission regulation (Reg. Art. 87a and Dir.Art.108 s - Policies -Operations Process Mapping -ICT IT requirements EMA/MSs Technical contribution Guidelines SOP/WIN/Templates IT tools 7
9 2. What will be delivered? (2/6) Implementation phasing plan July 2012 Q1 Q Phase I Q Q Phase II -Technical contribution to EC draft implementing measures - papers -Good Vigilance Practice and other guidelines -Documentation update -First round of Business Process Mapping -IT requirements 8 -Additional Business Process Mapping workshops -Standard Operating Procedures, Working Instructions, Templates -ICT tools -Documentation update -ICT tools maintenance
10 2. What will be delivered? (3/6) EMA/Member States technical contribution to EC implementing measures Reg. (EC) 1235/2010 Art. 87a and Dir. 2010/84/EC Art. 108 (a) The content and maintenance of the pharmacovigilance system master file kept by the MAH; (b) The minimum requirements for the quality system for the performance of pharmacovigilance activities by the Agency, the NCAs and MAH; (c) The use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities; 9
11 2. What will be delivered? (4/6) EMA/Member States technical contribution to EC implementing measures Reg. (EC) 1235/2010 Art. 87a and Dir. 2010/84/EC Art. 108 (d) The minimum requirements for the monitoring of data included in the EV database to determine whether there are new risks or whether risks have changed; (e) The format and content of electronic transmission of suspected adverse reactions by MSs and MAHs; (f) The format and content of electronic PSURs and RMPs; (g) The format of protocols, abstracts and final study reports of the PASS; 10
12 2. What will be delivered? (5/6) Several s under preparation Pharmacovigilance audits Coordination of safety announcements EU medicines Web-portal Products under additional monitoring Public hearings Transparency Etc,. 11
13 2. What will be delivered? (6/6) Structure of implementing measures and Good Vigilance Practice: GVP May Efficacy Studies MAH Quality System - Task 1 - Task 2 - Task 3 - Task n MSs Quality System - Task 1 - Task 2 - Task 3 - Task n EMA Quality System - Task 1 - Task 2 - Task 3 - Task n EC Implementing measures PSMF Good Vigilance Practice guidelines Terms, Formats, Standards EV data monitoring MAH Quality System Detailed guidance ADR format & content MSs Quality System Detailed guidance PSUR format & content EMA Quality System Detailed guidance RMP format & content PASS format & content Processes e.g Audit Inspection PSUR ADR reporting Literature monitoring Signal Detection & management PAES PASS RMP Effectiveness of risk minimisation 12 Special Products Decision making Referrals Safety announcement Website Content & maintenance Special Population
14 Any questions? 13
15 List of abbreviations ERMS-FG: European Risk Management Strategy Facilitation Group PSUR: Periodic Safety Update Report ADR: Adverse Drug Reaction RMP/S: Risk Management Plan/System EV: EudraVigilance SOP: Standard Operating Procedure WIN: Working Instruction ICT: Information and Communication Technology EMA: European Medicines Agency MSs: Member States PAE/SS: Post-Authorisation Efficacy/Safety Studies 14
Functioning of the PRAC
Functioning of the PRAC Sixth Stakeholders forum on the implementation of the new Pharmacovigilance legislation, November 8 th 2012 Presented by: Almath Spooner Vice Chair, Pharmacovigilance Risk Assessment
More informationEudraVigilance auditable requirement project
22 November 2017 EMA/835422/2016 Information Management Division EudraVigilance training plan (version 5) Project Maintenance Group 1 consultation 11 December 2015 Eudravigilance Expert Working Group consultation
More informationNew Pharmacovigilance legislation. Post-authorisation safety studies. ENCePP Plenary meeting. 3 May 2012
New Pharmacovigilance legislation Post-authorisation safety studies ENCePP Plenary meeting 3 May 2012 Presented by: Annalisa Rubino, PhV and Risk Management, EMA An agency of the European Union Why? Public
More informationSafety Measures in the new Pharmacovigilance System
Safety Measures in the new Pharmacovigilance System Dr. Harald Tietz Director Global Patient Safety & Regulatory Affairs, Germany Lilly Deutschland GmbH Documentation and reporting requirements: Centralisation
More informationSafety reporting requirements in the post marketing phase. Pharmacovigilance Specialty Committee SQA Conference March 2017 Washington
Safety reporting requirements in the post marketing phase Pharmacovigilance Specialty Committee SQA Conference March 2017 Washington DISCLAIMER These materials have been prepared solely for educational
More informationGuideline on good pharmacovigilance practices (GVP)
1 2 3 19 June 2012 EMA/119871/2012 4 5 Guideline on good pharmacovigilance practices (GVP) Module III Pharmacovigilance inspections Draft finalised by the Agency in collaboration with Member States and
More informationThe PRAC Roles and challenges Focus on RMPs and RMAs. Prof. Jean-Michel Dogné. Head of the Department of Pharmacy PRAC effective member
The PRAC Roles and challenges Focus on RMPs and RMAs Prof. Jean-Michel Dogné Head of the Department of Pharmacy PRAC effective member Rue de Bruxelles, 61 B-5000 Namur, Belgium Phone: 0032 (0)81 724289
More informationPharmacovigilance- Content of the New EU Legislation and Challenges for BfArM
Pharmacovigilance- Content of the New EU Legislation and Challenges for BfArM 12 th DGRA Annual Congress June 15 to 16, Bonn U. Hagemann Bundesinstitut für Arzneimittel und Medizinprodukte BfArM Visit
More informationPharmacovigilance: Information systems and services
Pharmacovigilance: Information systems and services Supporting business activities of the revised pharmacovigilance legislation through better information systems An agency of the European Union To deliver
More informationPharmacovigilance. An agency of the European Union
Pharmacovigilance An agency of the European Union Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions and other medicine-related
More informationInterdependencies of Pharmacovigilance and Regulatory Affairs
Lorenz userbridge 2013 Budapest, September 17th Interdependencies of Pharmacovigilance and Regulatory Affairs Dr. rer. nat. Markus Dehnhardt Deputy QPPV Biologist Toxicologist Medical advisor Agenda 1.
More informationEMA pharmacovigilance system manual
13 October 2016 EMA/623550/2013 Inspections, Human Medicines Pharmacovigilance & Committees Division Version 1.2 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000
More informationPublication of Risk Management Plan (RMP) summaries:
Publication of Risk Management Plan (RMP) summaries: Analysis of the experience of the 1-year pilot phase PCWP meeting November 2015 An agency of the European Union Why produce a Summary of the Risk Management
More informationNew EudraVigilance functionalities and the 2010 pharmacovigilance legislation preparing for change
New EudraVigilance functionalities and the 2010 pharmacovigilance legislation preparing for change Training Module PhV-M1 Overview of legal provisions that form the basis for the new EudraVigilance functionalities
More informationGuideline on good pharmacovigilance practices (GVP)
22 June 2012 EMA/816573/2011 Guideline on good pharmacovigilance practices (GVP) Module II Pharmacovigilance system master file Draft finalised by the Agency in collaboration with Member States and submitted
More informationThe European Commission's Proposal to Re-design Existing European Drug Safety Rules. An Industry View on Practical Implications
The European Commission's Proposal to Re-design Existing European Drug Safety Rules An Industry View on Practical Implications Margaret Walters Merck, Sharp & Dohme Ltd. The Second International Pharmaceutical
More informationEudraVigilance Vet. and Pharmacovigilance of vet. Medicinal products in Serbia
EudraVigilance Vet. and Pharmacovigilance of vet. Medicinal products in Serbia Presented by: Vladimir Raketić, DVM, spec; Audit /QM group Ministry of Agriculture, Forestry and Water Managment, Veterinary
More informationClinical Trial Safety Reporting requirements
Clinical Trial Safety Reporting requirements SME info day 20 Mar 2017 Presented by Sophia Mylona Clinical & Non-clinical Compliance, European Medicines Agency An agency of the European Union Article Regulation
More informationFormat and content of electronic periodic safety update reports (Technical contribution to EC implementing measure)
Format and content of electronic periodic safety update reports (Technical contribution to EC implementing measure) First Stakeholders Forum on the implementation of the new Pharmacovigilance legislation,
More informationGuideline on good pharmacovigilance practices (GVP)
9 October 2017 EMA/827661/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module IX Signal management (Rev 1) Date of coming into effect of first version 2 July 2012 Draft Revision 1* finalised
More informationExplanatory Note to GVP Module VII
31 October 2017 EMA/670256/2017 Human Medicines Evaluation Division Explanatory Note to GVP Module VII Since the start of the Periodic Safety Update Report (PSUR) single assessment (PSUSA), the procedure
More informationMircea Ciuca, MD Global Head Medical & Clinical Drug Safety
Mircea Ciuca, MD Global Head Medical & Clinical Drug Safety Disclaimer The views and opinions expressed in this presentation are solely those of the presenter and do not necessarily reflect those of Vifor,
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION PAPER ON COMPLIANCE WITH PHARMACOVIGILANCE REGULATORY OBLIGATIONS
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 15 November 2001 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION PAPER ON COMPLIANCE
More informationINTRODUCTION OF FEES TO BE CHARGED BY THE EMA FOR PHARMACOVIGILANCE
Ref. Ares(2012)723154-18/06/2012 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products authorisations, EMA Brussels, D(2012) INTRODUCTION OF FEES TO
More informationGuideline on good pharmacovigilance practices (GVP)
22 June 2012 EMA/827661/2011 (superseded version) Guideline on good pharmacovigilance practices (GVP) Module IX Signal management Draft finalised by the Agency in collaboration with Member States and submitted
More informationQ & A on PSUSA: Guidance document for assessors
31 October 2017 EMA/518909/2016 Human Medicines Evaluation Division Q & A on PSUSA: Guidance document for assessors Since the start of the Periodic Safety Update Report (PSUR) single assessment (PSUSA),
More informationGuideline on good pharmacovigilance practices (GVP)
9 October 2017 EMA/813938/2011 Rev 3* Guideline on good pharmacovigilance practices (GVP) Module VIII Post-authorisation safety studies (Rev 3) Date for coming into effect of first version 2 July 2012
More informationTrack III: International Clinical Trials: Global Compliance Norms and EU Focus
Track III: International Clinical Trials: Global Compliance Norms and EU Focus EU Focus Emmanuelle Voisin, PhD Principal, Voisin Consulting May 2008 Rationale Clinical trials in EU important part of health
More informationQuestions And Answers To Support The
Questions And Answers To Support The Implementation Of The Pharmacovigilance Legislation - Update This Question and answers section gives advice on regulatory issues in on the interpretation and implementation
More informationMonitoring safety of medicines for patients
Monitoring safety of medicines for patients Pharmacovigilance activities related to medicines for human use in the EU (COM(2016) 498) Health and Food Safety The information contained in this publication
More informationWissenswertes aus dem Bereich PHV
Wissenswertes aus dem Bereich PHV Dr. Susanne Wolf Dept. Assessment Pharmacovigilance AGES-Gespräche Vienna, 15.09.2016 Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH www.ages.at
More informationIntroductory cover note to the List of European Union reference dates and frequency of submission of Periodic Safety Update Reports
24 October 2016 EMA/606369/2012 Rev.15 Procedure Management and Committees Support Introductory cover note to the List of European Union reference dates and frequency of submission of Periodic Safety Update
More informationCMD(h) GUIDANCE FOR MAHs ON THE PHARMACOVIGILANCE SYSTEM AND RISK MANAGEMENT PLAN IN THE MUTUAL RECOGNITION & DECENTRALISED PROCEDURES
CMD(h) GUIDANCE FOR MAHs ON THE PHARMACOVIGILANCE SYSTEM AND RISK MANAGEMENT PLAN IN THE MUTUAL RECOGNITION & DECENTRALISED PROCEDURES 1. INTRODUCTION (BACKGROUND) November 2007 According to Article 8
More informationFourth Stakeholders forum on the implementation of the new Pharmacovigilance legislation
Fourth Stakeholders forum on the implementation of the new Pharmacovigilance legislation Module II - Pharmacovigilance system master file Presented by: Joanna Harper Inspections, Enforcement & Standards
More informationProcedure management of variations
Procedure management of variations Process changes made and current challenges Presented by Alberto Ganan and Iordanis Gravanis on 24 April 2015 Procedure Management Department An agency of the European
More informationPharmacovigilance. Training session for patients and consumers involved in EMA activities, 25 November Presented by: Priya Bahri
Pharmacovigilance Training session for patients and consumers involved in EMA activities, 25 November 2014 Presented by: Priya Bahri An agency of the European Union 2 Pharmacovigilance - the science concerned
More informationReview of three years of Post Authorization Safety Studies (PASS) landscape under the 2010 European Pharmacovigilance
Review of three years of Post Authorization Safety Studies (PASS) landscape under the 2010 European Pharmacovigilance Pierre Engel Priscilla Velentgas May 2016 Copyright 2016 Quintiles Your presenters
More informationPSMF in Practice Your Questions Answered! GPvP Symposium, 14 March 2014 Jonathan Rowell, Senior GPvP Inspector
PSMF in Practice Your Questions Answered! GPvP Symposium, 14 March 2014 Jonathan Rowell, Senior GPvP Inspector Content Answer industry questions related to the PSMF MHRA inspector s preparation: How we
More informationHOT TOPICS IN PV. Establishing a good Pharmacovigilance system: Essential elements 2 January 2014 Petach Tikva
HOT TOPICS IN PV International Society of Pharmacovigilance Establishing a good Pharmacovigilance system: Essential elements 2 January 2014 Petach Tikva Dr Irene FERMONT, MD, MSc, EUQPPV ISOP ISRAEL Coordinator
More informationApplies to: Signal Management Leads in the Signal Management service (P-PH-SMA) and personnel in the Learning and Development service (A-HR-LAD).
Work instructions Title: Training for signal management leads Applies to: Signal Management Leads in the Signal Management service (P-PH-SMA) and personnel in the Learning and Development service (A-HR-LAD).
More informationSCOPE Work Package 8 Lifecycle Pharmacovigilance. PSUR/PSUSA and Referral Recommendations
PSUR/PSUSA and Referral Recommendations 2016 Contents Acknowledgments 3 1. Introduction 4 1.1 Purpose of the document 4 1.2 Definitions and abbreviations 5 1.3 Attachments 5 1.4 Background 6 1.5 Context
More informationGuideline on good pharmacovigilance practices (GVP)
22 June 2012 EMA/816292/2011 (superseded version) Guideline on good pharmacovigilance practices (GVP) Module VII Periodic safety update report Draft finalised by the Agency in collaboration with Member
More informationPharmacovigilance Legislation: The Impact of What Is Happening in Europe
Miranda Z. Dollen, BSc (Hons) 1 Abstract Pharmaceutical companies, regulatory agencies, and contract service organizations are managing substantial and ongoing changes to pharmacovigilance legislation
More informationSCOPE Work Package 8 Lifecycle Pharmacovigilance. Practical Guide on PSUR / PSUSA Assessment
Practical Guide on PSUR / PSUSA Assessment 2016 Contents Acknowledgments 3 1. Introduction 4 1.1 Purpose of the document 4 1.2 Relevant guidelines 4 1.3 Definitions and abbreviations 5 2. Background 7
More informationPharmacovigilance Inspections Time to panic? Marie-Odile Hendrickx, DVM, MRCVS Pfizer Animal Health 13 December 2010
Pharmacovigilance Inspections Time to panic? Marie-Odile Hendrickx, DVM, MRCVS Pfizer Animal Health 13 December 2010 Content Legal basis What do agencies want? What happens Before During After How do you
More informationDoc. No. DPS/GDL/034 Revision No.: 0 Effective Date: 26 April 2018 Review-Due Date: 26 April 2021
National Drug Authority Head Office Rumee Towers Plot 19, Lumumba Avenue P. O. Box 23096 Kampala, Uganda Tel: 256-0414 - 255665/347391/2 E-mail: ndaug@nda.or.ug Website: http://www.nda.or.ug Doc. No. DPS/GDL/034
More informationPharmacovigilance - Regulatory perspective -
Pharmacovigilance - Regulatory perspective - Junko Sato Director for Risk Management, Office of Safety Pharmaceuticals and Medical Devices Agency (PMDA) Agenda Concept of Phamacovigilance Current Regulation
More informationUpdate on EMA Brexit preparedness
Update on EMA Brexit preparedness SME Office Info Day on Supporting innovative medicines development and early access 17 November 2017 Presented by Anthony Humphreys An agency of the European Union EMA
More informationEMEA/AD/258: Head of Sector Pharmacovigilance and Risk Management of Medicinal Products for Human Use (AD9).
EMEA/AD/258: Head of Sector Pharmacovigilance and Risk Management of Medicinal Products for Human Use (AD9). Responsible, under the Head of Unit for the Post-Authorisation Evaluation of Medicinal Products
More information-Regulation (EC) No.1394/2007 -Regulation (EC) No. 668/2009
Introduction to Advanced Therapy Medicinal Products Regulation -Regulation (EC) No.1394/2007 -Regulation (EC) No. 668/2009 -Directive 2009/120/EC Dr. Maura O Donovan F.R.C.O.G. MA MD M.R.C.P.I. CAT member
More informationWork plan for the CVMP Pharmacovigilance Working Party (PhVWP-V) 2018
30 January 2018 EMA/CVMP/PhVWP/384293/2017 Committee for Medicinal Products for Veterinary Use (CVMP) Work plan for the CVMP Pharmacovigilance Working Party (PhVWP-V) 2018 Chairpersons Chair: E. Dewaele
More informationWork programme Adopted by the Management Board on 18 December December 2014 EMA/773839/2014 Rev. 1 Management Board
18 December 2014 EMA/773839/2014 Rev. 1 Management Board Work programme 2015 Adopted by the Management Board on 18 December 2014 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
More informationSCOPE Work Package 8 - LIFECYCLE PHARMACOVIGILANCE Executive Summary Report
SCOPE Work Package 8 - LIFECYCLE PHARMACOVIGILANCE Executive Summary Report Authors: Jelena Ivanovic, Anja Schiel, Jane Woolley, Alison Shaw, Marco Di Girolamo, Consuelo Cicalese, Virginia Cuconato, Elena
More informationMedical Literature Monitoring
Medical Literature Monitoring 5 th Industry Platform on the implementation of EU pharmacovigilance legislation Presented by Tom Paternoster-Howe on 15 September 2015 EMA/Information Management/Data Standardisation
More informationTopic 5: Competency Authors: Jelena Ivanovic; Marco Di Girolamo (Version 4 June 2015)
SCOPE Work Package 8 - LIFECYCLE PHARMACOVIGILANCE Survey Report Topic 5: Competency Authors: Jelena Ivanovic; Marco Di Girolamo (Version 4 June 2015) 1 Introduction 1.1 Purpose of the document The purpose
More informationE2B, Safety databases & Eudravigilance
E2B, Safety databases & Eudravigilance Delphine BERTRAM, PharmD Hospices Civils de Lyon France HOT TOPICS IN PV Hod Hasharon 7 May 2014 Dr Irene Fermont- ISOP ISRAEL Dganit Even Sapir -MSD Spontaneous
More informationGuideline on the processing of renewals in the centralised procedure
22 June 2012 EMEA/CHMP/2990/00 Rev.4 Committee for Human Medicinal Products (CHMP) Guideline on the processing of renewals in the centralised procedure Transmission to CPMP November 2000 Release for consultation
More information2008 Pharmaceutical Package - Impact on Implementation by BfArM
2008 Pharmaceutical Package - Impact on Implementation by BfArM Dr. Karl Broich Head of Licensing Division 4, German Alternate at CHMP Federal Institute for Drugs and Medical Devices (BfArM) Kurt-Georg-Kiesinger-Allee
More informationSCOPE Work Package 8 Lifecycle Pharmacovigilance. Risk Management Plan Recommendations
Lifecycle Pharmacovigilance Risk Management Plan Recommendations 2016 Lifecycle Pharmacovigilance RMP Recommendations Contents Acknowledgments 3 1. Introduction 4 1.1 Purpose of the document 4 1.2 Definitions
More informationInformation on the Member States requirement for the nomination of a pharmacovigilane (PhV) contact person at national level
19 July 2017 EMA/INS/PhV/445316/2017 Committees and Inspections Information on the Member s requirement for the nomination of a pharmacovigilane (PhV) contact person at national level Based on Pharmacovigilance
More informationEuropean Medicines Agency post-authorisation procedural advice for users of the centralised procedure
11 December 2017 EMEA-H-19984/03 Rev. 75 Human Medicines Evaluation Division European Medicines Agency post-authorisation procedural advice for users of the This integrated version has been created for
More informationThis video gives an overview of the centralised procedure at the European Medicines Agency
This video gives an overview of the centralised procedure at the European Medicines Agency In Europe today, all medicines must have a marketing authorisation before they can be used by patients And there
More informationReport to the European Commission on Pharmacovigilance audits carried out in the Bulgarian Drug Agency period of time from April 2011 to June 2013
Report to the European Commission on Pharmacovigilance s carried out in the Bulgarian Drug Agency period of time from April 2011 to June 2013 1. INTRODUCTION This report provides an overview of the s conducted
More informationFergus Sweeney, European Medicines Agency
Fergus Sweeney, European Medicines Agency Disclaimer The views presented in this presentation/these slides are those of the author and should not be understood or quoted as being made on behalf of the
More informationEU health policy. Strategy for the pharmaceutical industry and biosimilars. Salvatore D'Acunto. DG Research. DG Internal Market. DG Health & Consumers
Strategy for the pharmaceutical industry and biosimilars Salvatore D'Acunto European Commission Enterprise and Industry Directorate-General London, 3 April 2014 EU health policy DG Research R&D, innovation
More informationImportance of Pharmacovigilance for Pharmaceutical Industry
Importance of Pharmacovigilance for Pharmaceutical Industry JARIR AT THOBARI, MD, DPHARM, PHD FACULTY OF MEDICINE GADJAH MADA UNIVERSITY YOGYAKARTA, INDONESIA Role of Pharma Company Globally Investment
More informationQ/A-LIST FOR THE SUBMISSION OF VARIATIONS ACCORDING TO COMMISSION REGULATION (EC) 1234/2008
Q/A-LIST FOR THE SUBMISSION OF VARIATIONS ACCORDING TO COMMISSION REGULATION (EC) 1234/2008 1. General questions Doc. Ref: CMDh/132/2009/Rev.20 May 2013 Question 1.1 What is the definition of MAH? According
More informationEudraVigilance access policy for medicines for human use
23 August 2011 EMA/759287/2009 corr. Patient Health Protection Draft agreed by the EudraVigilance Expert Working Group December 2007 Consultation with the EudraVigilance Steering Committee February 2008
More informationEU Portal and Database Update
EU Portal and Database Update TOPRA 4 October 2017 Presented by Noémie Manent on 4 October 2017 Committees and Inspections Department An agency of the European Union Table of content EMA Portal and Database
More informationVOLUME 9 - PHARMACOVIGILANCE. Medicinal Products for Human and Veterinary Use
VOLUME 9 - PHARMACOVIGILANCE Medicinal Products for Human and Veterinary Use FOREWORD Directive 75/319/EEC as amended by Commission Directive 2000/38/EC of 5 th June 2000 and Directive 81/851/EEC as amended
More informationTelematics Governance
Telematics Governance Telematics Governance Model 1 EU Telematics Management Board (EU TMB) The EU TMB is a strategic governance body principally responsible for establishing the EU Telematics strategy
More informationATMPs guideline on Safety and Efficacy follow-up and risk management
ATMPs guideline on Safety and Efficacy follow-up and risk management Presented by Caroline Voltz-Girolt EMA Product Lead - Oncology, Haematology and Diagnostics Office Scientific and Regulatory Management
More informationEuropean Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
11 December 2017 EMA/821278/2015 Human Medicines Research and Development Support European Medicines Agency pre-authorisation procedural advice for users of the This integrated version has been created
More informationDi Renzo Regulatory Affairs ROME - MILAN - LONDON
Di Renzo Regulatory Affairs ROME - MILAN - LONDON Di Renzo Regulatory Affairs In 1985, Di Renzo Regulatory Affairs began its regulatory consulting for medicines for human and veterinary use, food and dietary
More informationEMA / FDA efforts towards Regulatory Harmonisation - Transatlantic Trade and Investment Partnership (TTIP)
EMA / FDA efforts towards Regulatory Harmonisation - Transatlantic Trade and Investment Partnership (TTIP) European Health Forum - 3 rd October 2013 Falk Ehmann MD, PhD European Medicines Agency - London
More informationBrexit Guidance for Stakeholders Human and veterinary medicines
Brexit Guidance for Stakeholders Human and veterinary medicines DATE: 03 JANUARY 2018 V.2 This guide does not purport to be an interpretation of law and/or regulations. The content provided is subject
More informationProcedural advice on publication of information on negative opinions and refusals of marketing authorisation applications for human medicinal products
02 May 2013.. Procedural advice on publication of information on negative opinions and refusals of marketing authorisation applications for human medicinal products 7 Westferry Circus Canary Wharf London
More informationImpact of the transposition of the European Clinical Trials Directive. CEMO, Paris 17 November 2004
Impact of the transposition of the European Clinical Trials Directive CEMO, Paris 17 November 2004 Dr Martine Dehlinger-Kremer VP Regulatory Affairs International Agenda Overview of key areas of Directive
More informationGuideline on good pharmacovigilance practices (GVP)
4 August 2016 EMA/168402/2014 Corr* Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations II: Biological medicinal products Draft finalised by the Agency in
More informationUpdate ICSR Reporting. EudraVigilance Reporting Getting ready for E2B (R3) Disclaimer:
Update ICSR Reporting Dr. Waltraud Trabe / Mag. Katharina Weber Austrian Federal Office forsafety in Healthcare Institute of Surveillance Dep. BTVI (Blood, Tissue & Vigilance) Traisengasse5, 1020 Vienna
More informationSCOPE Work Package 8 Lifecycle Pharmacovigilance. PASS Recommendations
PASS Recommendations 2016 Contents Acknowledgments 3 1. Introduction 4 1.1 Purpose of the document 4 1.2 Definitions and abbreviations 5 1.3 Attachments 5 1.4 Background 6 1.5 Context 6 2. Aims 7 3. Methodology
More informationSystematic Risk Management: An Overview of ICH Q-9
Systematic Risk Management: An Overview of ICH Q-9 March 12, 2014 12014 ParagonRx International LLC Today s Session Systematic Risk Management: An Overview of ICH Q-9 Speakers: Jeff Fetterman, President,
More informationSaudi FDA Drug Approval Process. Dr. Mohammed A. Alquwaizani Consultant- Chief of the scientific office Saudi Food and Drug Authority
Saudi FDA Drug Approval Process Dr. Mohammed A. Alquwaizani Consultant- Chief of the scientific office Saudi Food and Drug Authority Objective Describe the drug regulation practice in Saudi Arabia and
More informationAccession Preparation: Situation in Croatia
Accession Preparation: Situation in Croatia Siniša Tomić, PhD, Associate Professor Head of the Agency for Medicinal Products and Medical Devices (HALMED), Croatia Content: Croatian Agency for Medicinal
More informationThe Revised SmPC Guideline
The Revised SmPC Guideline 1 st June,2010 DIA Regulatory Forum, London Dr. PatrickSALMON SALMON, IMB The Revised SmPC Guideline Reasons for revising the Guideline dl Changes, Implementation and Consequences
More informationSCOPE Work Package 8 Lifecycle Pharmacovigilance. Practical Guide on Safety-related Referrals
Practical Guide on Safety-related Referrals 2016 Practical Guide on Safety-related Referrals Contents Acknowledgments 3 1. Introduction 4 1.1 Purpose of the document 4 1.2 Relevant guidelines 4 1.3 Definitions
More informationUmsetzung des Review 2004 Auswirkungen auf das Europäische Zulassungssystem insbesondere auf das dezentrale und das MR-Verfahren
Umsetzung des Review 2004 Auswirkungen auf das Europäische Zulassungssystem insbesondere auf das dezentrale und das MR-Verfahren DGRA - Jahreskongress, Bonn Bundesministerium für Gesundheit und Frauen
More informationEudraVigilance NEU. Mag. pharm. Katharina Weber. BASG/AGES Medizinmarktaufsicht Institut Überwachung - Abteilung Blut, Gewebe und Vigilanz
EudraVigilance NEU Mag. pharm. Katharina Weber BASG/AGES Medizinmarktaufsicht Institut Überwachung - Abteilung Blut, Gewebe und Vigilanz AGENDA EudraVigilance neu Legal Requirements Process Change Management
More informationMandate and objectives for the EMA Working Party on Quality Review of Documents (QRD)
1 July 2014 EMA/403106/2014 Mandate and objectives for the EMA Working Party on Quality Review of Documents 1. General considerations The European Medicines Agency (EMA) created an ad hoc Working Group
More informationGuideline on good pharmacovigilance practices (GVP)
9 October 2017 EMA/876333/2011 Rev 4* Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 4) Date for coming into effect of first version 2 July 2012 Date for coming into effect
More informationUniversity joins Industry: Clinical Trials & Drug Safety. Aula Magna-Facultad de Farmacia 11 Marzo 2015
University joins Industry: Clinical Trials & Drug Safety Aula Magna-Facultad de Farmacia 11 Marzo 2015 Contents Background, key points and basic knowledge Department tasks and responsibilities Importance
More informationNIS Considerations - France An overview of the considerations when conducting Noninterventional
NIS Considerations - France An overview of the considerations when conducting Noninterventional Studies in France Stuart McCully CHCUK Ltd NIS-C-FR-2014 (Mar 2014) Dr Stuart McCully 2014 NIS-C-FR-2014
More informationOpinion/ Notification 1 issued on. Commission Decision Issued 2 / amended on
Procedural steps taken and scientific information after the authorisation Application Scope number IAIN/0020/G Opinion/ Notification 1 issued on Commission Decision Issued 2 / amended on Product Information
More informationReview of EU Clinical Trial Directive. 15 May 2012 Mike Beckers Sidley Austin LLP, Brussels
BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG LONDON LOS ANGELES NEW YORK PALO ALTO SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C. Review of EU Clinical Trial Directive 15
More informationEMA. François Houÿez. Director of Treatment Information & Access Eurordis Summer School 2012, Barcelona
Patients @ EMA François Houÿez Director of Treatment Information & Access Eurordis Summer School 2012, Barcelona Please comment (fictitious case) A pulmonary hypertension patients organisation collects
More informationRegulatory Requirements
Regulatory Requirements CTTI Quality by Design Workshop 28-29 Jan 2013 Rockville, MD Fergus Sweeney, Head, Compliance and Inspections, European Medicines Agency An agency of the European Union Disclaimer
More informationAgency and Internal Labeling
Agency and Internal Labeling Audits Joseph McMillian, MA Heartland Compliance Services LLC Internal Labeling Audits The views and opinions expressed in the following PowerPoint slides are those of the
More information