The new Pharmacovigilance legislation and implementation planning

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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

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