Implementation and Impact of the PV Regulations - how are we doing? Sue Rees Eisai Europe Ltd. & John Barber, Dr Reddy's Laboratories
|
|
- Leslie Doyle
- 5 years ago
- Views:
Transcription
1 Implementation and Impact of the PV Regulations - how are we doing? Sue Rees Eisai Europe Ltd. & John Barber, Dr Reddy's Laboratories
2 Agenda PSMF PSURs Solicited sources RMPs Inspections Signal detection Impact on Resources
3 Ground Rules Session Leaders to give an overview of status and issues / challenges Delegates to give their experiences, pose questions, challenge assumptions etc Confidential sharing of experiences Session leader briefly summarise discussion Move on to next topic General Q&A at the end if time
4 PV SYSTEM MASTER FILE
5 Status Commission Implementing Regulation finalised 19 June 2012 GVP Module II issued 22 June 2012 Required by July 2015 or with first MAA / Renewal after 2 July 2012 No template but lots of guidance Summary only to be submitted must be available in 7 days
6 Summary of PSMF
7 Challenges - Structure PSMF Summary Only when QPPV changes PSMF Master Document Only when major changes to PV system PSMF Annexes 1 person or multi-input? Dynamic and constantly changing
8
9 Challenges Information gathering Global information not just from PV Organisational structure including FTEs Local affiliates with multi-faceted roles List of products and contacts in all countries CAPs not marketed in countries with no affiliate Full list of organised data collection schemes SOPs for all critical processes easier if you have global processes
10 Challenges Co-marketing MRP Whose PSMF? Response from MHRA: You would be required to submit each PSMF to all concerned member states, much in the same way that you would have to submit a batch release site to all member states, even though it may only be used in a single country. Each PSMF will require its own variation, therefore a group application should be submitted.
11 Other challenges / discussion points?
12 PSURS
13 PSURs Status GVP Module VII issued June 2012 EURD list not finalised until October 2012 New format mandatory from 10 January 2013 Critical evaluation of benefit: risk required from July 2013 EURD list mandatory from 1 April 2013 Best practice guidelines on submission of renewals issued September 2013
14 PSURs Issues Phased implementation 3 phases EURD list and harmonisation with global requirements Impact on global requirements 60 days RoW vs 70/90 days in Europe Formatting differences SBRs no longer accepted Impact on generic sector PSURs no longer routinely required for generics Competent authorities not following the EURD list What are the safety issues requiring a generic PSUR? Different requirements within a product class
15 PSURs Issues Impact on innovators Significant increase in workload Benefit assessment Benefit:risk assessment Single assessment when? Addendum to the clinical overview Almost a PSUR but not quite New renewal requirements effective from April or September 2012?
16 Other challenges / discussion points?
17 SOLICITED SOURCES OF DATA
18 Status GVP Module VI is clear All data from organised data collection schemes is solicited (except some named patient or compassionate supply where AEs are not actively sought) EMA Q&A July 2012 All adverse events should be collected by the MAH and assessed as to whether or not they are suspected adverse reaction
19 Causality assessments EMA Q&A July 2012 MAH should exercise due diligence in asking the primary source for their opinion on causality Even if the primary source is the patient Where causality is missing MAH should exercise judgement on whether the report is a valid ICSR which should be reported
20 Recent developments Efpia position paper on PSPs and MR Clearer definition of PSP Propose some reports are classified Spontaneous Plan to generate further data Correspondence from Peter Arlett that further guidance is being developed and will be subject to consultation shortly
21 Challenges - Different interpretations Only collect non-serious (events? reactions?) if protocol specified Change all protocols to specify collection of non-serious All new protocols to specify collection of nonserious
22 Challenges Causality Who makes causality / serious assessment Global drug safety team Local Safety officer CRO Reporter
23 Challenges Safety database Will you add all events (including non-serious events) to your global safety database? Translation burden (some Japanese PMS have 5000 events reported) How will you factor in to signal detection? Do all ODCS, globally for products authorised in EU have a process for collecting adverse reactions?
24 Other challenges / discussion points?
25 RMPS
26 RMPs Status GVP Module V issued June 2012 Templates issued November 2012 Mandatory of all new applications from July 2012 New format mandatory from 10 January 2013 Modular format, compatible with PSUR sections Lay summary required Updates required, annual for 3 years then 3 yearly
27 RMPs Issues Phased implementation Impact on generic sector Access to innovator s RMP Impact on innovators Preparation of lay summary Updates when and how No/limited assessment experience
28 Other challenges / discussion points?
29 AUDIT AND INSPECTION
30 Status GVP Module I PV Systems and their Quality Systems GVP Module II PV System Master File Came in to effect 2 July 2012 GVP Module III Pharmacovigilance Inspections GVP Module IV Pharmacovigilance Audits Came in to effect 13 December 2012
31 Audit Strategy and Planning Strategic level audit planning An audit strategy over 2-5 years which should be endorsed by upper management Tactical level audit planning A 1 years audit programme, setting audit objectives, and the extent and boundaries of the audits in that programme Operational level audit planning An audit plan for individual audit
32 Audit Strategy and Planning Strategic level audit planning Our 5 years strategy is to Conduct PV audits of the affiliates based on the results of an annual risk based questionnaire All offices will be audited at least every 3 years All distributors collecting AE reports will also be in scope for audits All PV global centres will be audited at least annually Tactical level audit planning In 2013 a full PV system audit will be conducted at the EU PV centre Affiliate audits of Germany, Spain and Belgium will be conducted Distributors X & Y will be audited in line with SDEA Audit scope will include key interface departments Operational level audit planning The audit on France will take place in May Company Z has been engaged to conduct the audit The agenda for the audit will cover the following areas etc
33 Reporting Audit Findings The audit process should include communicating the audit findings to the auditee and to management and allow feedback Issues that need to be urgently addressed should be communicated in an expedited manner to management and senior management QPPV should receive relevant audit reports Audit findings should be graded in order to indicate their relative risks impacting the pharmacovigilance system The grading system should be defined in the description of the quality system for pharmacovigilance Critical and major findings must be reported in the PSMF until resolved
34 Preparing for an Inspection DDPS or PV System Master File? Whichever is in place and up to date! Don t claim to have a PSMF if you don t have one! May still have to produce specific listings or questionnaires for Inspectors May sure it is checked and that those who will be at the forefront of the Inspection know what is in it! Understand the Transitional Arrangements When should you change and when will you change? Ensure Core processes are documented NB: GVP Module I has no transition timeframe!
35 Hot Topics Events of Interest Off label use with no adverse event Occupational Exposure How are you collecting? Has everyone been trained? How are you reviewing for signal detection? How are you following up pregnancy reports?
36 Hot Topics Third Parties Are your agreements comprehensive and up to date with new legislation? Consider simple agreement to cover additional requirements in interim Do you have plans in place to audit your third parties? What level of training have they had? January 2013
37 Hot Topics - Processes Are your processes well documented and up to date Changes in ICSR reporting PSUR production (inc training and QC) Signal detection Responding to regulatory requests (including assessment reports) What processes do you have to ensure Quality? ICSRs PSURs Translations January 2013
38 Other challenges / discussion points?
39 SIGNAL DETECTION
40 Signal Detection Status GVP Module IX issued June 2012
41 Signal Detection Issues No clear and unequivocal guidance on what should be done and when More robust processes required? Access to EudraVigilance data, when and what? Role of the PRAC
42 Other challenges / discussion points?
43 IMPACT ON RESOURCES
44 Resource Challenge Manage PSMF PBRER / PSUR complexities RMPs for generics Lay summary in RMP Non-serious ICSR reporting Collecting non-serious solicited events Collecting off label use with no ADR Fewer PSURs for established products (only in EU) Eventual EV reporting Less country specific gold plating? Fewer variations related to DDPS
45 Judge a man by his questions not his answers Voltaire
PSMF 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 informationPharmacovigilance System Master file
IMPLEMENTING MEASURES IN ORDER TO HARMONISE THE PERFORMANCE OF THE PHARMACOVIGILANCE ACTIVITIES PROVIDED FOR IN DIRECTIVE 2001/83/EC AND REGULATION (EC) NO 726/2004 Pharmacovigilance System Master file
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 informationRecent developments in Pharmacovigilance from the Regulator s Perspective. In strategy, competence, quality and flexibility
Recent developments in Pharmacovigilance from the Regulator s Perspective In strategy, competence, quality and flexibility Pharmacovigilance Regulatory Affairs Operations Medical Writing & toxicology Recent
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 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 informationImplementing the New Pharmacovigilance Legislation
Implementing the New Pharmacovigilance Legislation Irish Medicines Board, Pharmacovigilance Information Day, Dec 2011 Dr. Almath Spooner Vigilance Assessment Manager, Human Products Monitoring Department
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 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 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 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 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 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 informationAdjusting to Effectively Meet the New European Union Pharmacovigilance Requirements
Adjusting to Effectively Meet the New European Union Pharmacovigilance Requirements Deirdre McCarthy Michelle Bulliard GRP Webinar 31 January 2013 Copyright 2013 Quintiles Your Presenters Deirdre McCarthy
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 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 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 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)
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 informationFunctioning 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 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 informationRole of International PVQA. Allison Jack, PVQA Director, GSK 24 th October 2017, Milan
Role of International PVQA Allison Jack, PVQA Director, GSK 24 th October 2017, Milan Agenda What does Regulations say about audits? Expectations of PVQA Organisation of PVQA What qualifications does a
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 informationPharmacovigilance System in Russia and the EAEU
Pharmacovigilance System in Russia and the EAEU Authors: Sergey Simeniv CEO X7 Research, CRO; Olga Latysheva Head of Pharmacovigilance Department X7 Research, CRO; Dmitry Kryuchkov Executive Director X7
More informationThe new Pharmacovigilance legislation and implementation planning
The new Pharmacovigilance legislation and implementation planning Second Stakeholders meeting 17 June 2011 European Medicines Agency, London, UK Presented by: Franck Diafouka Manager, Pharmacovigilance
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 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 informationRe: PCIM/11/01 Public Consultation on Implementing Measures for Pharmacovigilance
07 November 2011 By email: sanco pharmaceuticals@ec.europa.eu Directorate General for Health and Consumers Unit SANCO/D/3 BE 1049 Brussels Belgium Dear Sirs, Re: PCIM/11/01 Public Consultation on Implementing
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 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 informationGood Pharmacovigilance Practice Tunisian guidelines
Good Pharmacovigilance Practice Tunisian guidelines Introduction Arab ministers of health came to a common decree (number 7) in their 37th regular meeting in March 2012. The Higher Technical Committee
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 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 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 informationEphMRA Adverse Event Reporting Guidelines 2016
EphMRA Adverse Event Reporting Guidelines 2016 Based upon the Guideline on good pharmacovigilance practices (GVP) Module VI Management and reporting of adverse reactions to medicinal products European
More informationQPPV Association and Training Part 2 Session Introduction
QPPV Association and Training Part 2 Session Introduction Steve Douglas QPPV SGD Consulting Limited PrimeVigilance Ltd Disclaimer The views and opinions expressed in the following PowerPoint slides are
More informationAgenda item 4.1 Draft proposal - Notifications of the location of the Pharmacovigilance System Master File (PSMF)
EMA Implementation Working Group with EU Pharmaceutical Industry Associations on the implementation of Article 57(2), second subparagraph of Regulation (EC) 726/2004 Agenda item 4.1 Draft proposal - Notifications
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 informationNAFDAC GOOD PHARMACOVIGILANCE
NAFDAC GOOD PHARMACOVIGILANCE PRACTICE GUIDELINES 2016 NAFDAC GOOD PHARMACOVIGILANCE PRACTICE GUIDELINES 2016 NATIONAL AGENCY FOR FOOD AND DRUG NAFDAC NAFDAC GOOD PHARMACOVIGILANCE PRACTICE GUIDELINES
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 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)
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 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 informationGuideline on Good Pharmacovigilance Practices Module V- Pharmacovigilance System Master File
Guideline on Good Pharmacovigilance Practices Module V- Pharmacovigilance System Master File Turkish Medicines and Medical Devices Agency 16.02.2015 CHAPTER I... 2 1.1. Introduction... 2 CHAPTER II...
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 informationFrameworks for use of social media in pharmacovigilance. Sabine Brosch, European Medicines Agency
Frameworks for use of social media in pharmacovigilance Sabine Brosch, European Medicines Agency Frameworks for use of social media in pharmacovigilance Objectives Assess the current regulatory framework
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 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 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 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 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 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 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 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 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 informationReminder (VICH charter)
Dr. Marie Hendrickx Head of EU Pharmacovigilance Pfizer Animal Health IFAH Europe Representative VICH Electronic Standards Implementation Expert Working Group VICH Workshop Presentation of 2 Pharmacovigilance
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 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 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 informationAdvance Topics in Pharmacoepidemiology. Risk Management. Conflict of Interest Declaration. Benefit Harm Profile?
Advance Topics in Pharmacoepidemiology Risk Management 2012 Mid-Year ISPE Meeting Miami, April 21-23, 2012 Ariel E., Arias MD, PhD - Fac. Pharmacy; Université de Montréal - Biologics & Genetic Therapies
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 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 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 informationOptimising the Contribution of Regulatory Affairs to Product Development, Maintenance and Commercialisation
TOPRA MODULE Optimising the Contribution of Regulatory Affairs to Product Development, Maintenance and Commercialisation Case study 2 - Management of Regulatory Affairs Department ENABLING AND PROMOTING
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 informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Audits and Inspections SOP-QMS-004 Version Number 4 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov 2018 Author(s) Reviewer(s)
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 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 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 informationCouncil of the European Union Brussels, 23 September 2016 (OR. en)
Council of the European Union Brussels, 23 September 2016 (OR. en) 11680/16 ADD 1 REV 1 PHARM 52 SAN 311 MI 533 COVER NOTE From: date of receipt: 8 August 2016 To: No. Cion doc.: Subject: Secretary-General
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 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 informationBULGARIAN ASSOCIATION FOR DRUG INFORMATION (BADI)
1 BULGARIAN ASSOCIATION FOR DRUG INFORMATION (BADI) With the kind support from the Medical University - Sofia, organizes its regular autumn course on Pharmaceutical Regulations on the following topics
More informationPHARMACOVIGILANCE IN AND EMERGING MARKETS: AN INDUSTRY PERSPECTIVE. Shashidhar Swamy (Head, Pharmacovigilance) Wockhardt limited, Mumbai
PHARMACOVIGILANCE IN AND EMERGING MARKETS: AN INDUSTRY PERSPECTIVE Shashidhar Swamy (Head, Pharmacovigilance) Wockhardt limited, Mumbai 1 Disclaimer The content expressed in this presentation is solely
More informationA practical guide to achieving and maintaining global oversight and ensuring end-to-end pharmacovigilance
FOR PHARMA & LIFE SCIENCES WHITE PAPER A practical guide to achieving and maintaining global oversight and ensuring end-to-end pharmacovigilance The increasing complexity of today s pharmaceutical industry
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 informationSFDA Pharmacovigilance System Explained
مركز د. صالح عبدهللا باوزير لإلستشارات الصيدالنية Prof.BawazirPharmaConsultingCenter() SFDA Pharmacovigilance System Explained Dates of The Training 9-12 October 2017 RIYADH, SAUDI ARABIA KEY TOPICS OVERVIEW
More informationRAC (EU) Examination Study Checklist
RAC (EU) Examination Study Checklist Instructions: Use this checklist to track your progress when preparing for the RAC (EU) certification examination. When you begin your studying, each task statement
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 informationGood Clinical Practice (GCP): how does a laboratory that supports a clinical trial ensure compliance with these Regulations
Good Clinical Practice (GCP): how does a laboratory that supports a clinical trial ensure compliance with these Regulations 9th edition of Synevo Clinical Research Symposium. 17 th November 2017 Bucharest.
More informationMaintenance of Mature and Generic Products
Maintenance of Mature and Generic Products A Pragmatic Approach to Successfully Navigating the Safety and Regulatory Continuum Background While development of promising new products is an obvious area
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 informationetmf A Regulators Perspective Paula Walker, GCP Operations Manager & Senior GCP Inspector
etmf A Regulators Perspective Paula Walker, GCP Operations Manager & Senior GCP Inspector Agenda EU Legislation and Guidance News/Updates relating to TMF Structure and Content of e/tmf Inspecting etmfs
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 informationInspections: an academic perspective
Inspections: an academic perspective Patricia Henley Quality and Governance Manager Head, Research Governance & Integrity Office London School of Hygiene & Tropical Medicine Email: patricia.henley@lshtm.ac.uk
More informationFDA Requirements 5/16/2011. FDA and new IND regs. Changes on the horizon: CIOMS IX ICH upcoming initiatives
Session Overview (1) Although the role of the Qualified Person responsible for Pharmacovigilance is mandated by the European legislation, the QPPV is held responsible for the establishment and the maintenance
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 - 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 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 informationData Collection Tools Functions, Indicators & Sub-Indicators
Data Collection Tools 27- Functions, Indicators & A. National regulatory system Indicator RS1: Legal framework for establishment of a regulatory system, mandate and enforcement power for each function
More informationInstructions on Periodic Safety Update Reports
1 Introduction Instructions on Periodic Safety Update Reports A Periodic Safety Update Report (PSUR) is intended to provide an update of the worldwide safety experience of a VMP to Competent Authorities
More informationPharmacovigilance Playbook (Part 1 of 2)
PHARMACOVIGILANCE AND RISK MANAGEMENT Pharmacovigilance Playbook (Part 1 of 2) Compiled By: Dr. Mufti Suhail Sayeed James Lind Institute www.jliedu.com www.jli.edu.in James Lind Institute www.jliedu.com
More informationA COURSE IN DRUG REGULATIONS Of the Bulgarian Association of Drug Information (BADI)
A COURSE IN DRUG REGULATIONS Of the Bulgarian Association of Drug Information (BADI) on 11 and 25 October, 15 and 29 November, 6 December 2013 Venue Auditorium of the National Centrе of Infectious and
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 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 informationE2B(R3): THE INSIDE SCOOP FOR PRODUCT SAFETY TEAMS IN LIFE SCIENCES
E2B(R3): THE INSIDE SCOOP FOR PRODUCT SAFETY TEAMS IN LIFE SCIENCES PREPARING FOR E2B(R3) T he electronic transmission of adverse event information to stakeholders, using the International Conference on
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 informationAdverse Event Reporting
Adverse Event Reporting AE Case Receipt When we receive a case, we induct it through a well-oiled process that reduces the number of subsequent queries, classifies events appropriately, and increases the
More information