The new Pharmacovigilance legislation and implementation planning Second Stakeholders meeting 17 June 2011 European Medicines Agency, London, UK Presented by: Franck Diafouka Project Manager, Pharmacovigilance and Risk Management sector An agency of the European Union
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 Concept Papers; 1
Governance – EMA (1/ 5) • EMA Project 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
1. Governance – EU Network (2/ 5) Project Oversight Committee (ERMS-FG) Project Coordination Group 6 EMA/ MSs Project Teams EMA/ MSs EMA/ MSs EMA/ MSs EMA/ MSs EMA/ MSs EMA/ MSs Project Project Project Project Project Project Team 1 Team 2 Team 3 Team 4 Team 5 Team 6 - Audit/ PSURs ADR reporting -RMP/ -Committees/ -Communica- Inspections / Additional PASS/ PAES Referrals tion/ Monitoring/ -Effectiveness Transparency -Signals of risk ICT Group Minimisation 12 EMA Subproject Teams Lit. monit/ EMA Task- PSUR Product Info. Committees Fees RMS Signal detect. Force PASS/ PAES EV/ ADR rep. Referrals Com./ Transp Insp./ PhV sy. PhV audits 3
1. Governance – working methodology (3/ 5) Heads Heads Concept Concept Impl. Impl. of Medicines of Medicines Informed Informed Paper Paper Meas. Meas. Agencies Agencies Project Project Status Status Concept Concept Impl. Impl. Adopted Adopted Oversight Oversight Report Report Paper Paper Meas. Meas. ERMS FG ERMS FG Project Project Status Status Concept Concept Impl. Impl. Adopted Adopted Coordination Coordination Report Report Paper Paper Meas. Meas. Group Group Concept Concept Impl. Impl. Actions Actions Issue Issue Tracking Tracking Status Status Drafted/ Drafted/ Project Project Paper Paper Meas. Meas. Table Table Log Log Table Table Report Report Agreed Agreed Teams Teams Subproject Subproject Actions Actions Issue Issue Tracking Tracking Concept Concept Impl. Impl. Drafted Drafted Teams Teams Table Table Log Log Table Table Paper Paper Meas. Meas. 4
1. Governance – Reporting timelines (4/ 5) Friday 2 weeks before CHMP Subproject Teams submit Status Report Friday Project Coord. Group Week before CHMP submits Status Report to ERMS FG Project Teams submit Status Report W ednesday Week after CHMP Project Coord. Group meets to review Status Reports W ednesday 5 CHMP week
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
2. What will be delivered?(1/ 6) Deliverables Hierarchy of rules - Regulation (EC) 1235/ 2010 - Directive 2010/ 84/ EC EC I m plem enting Measures EMA/ MSs = Commission regulation Technical contribution (Reg. Art. 87a and Dir.Art.108 Concept Papers Guidelines - Policies Process Mapping - Operations SOP/ WIN/ Templates - I CT I T requirem ents IT tools 7
2. What will be delivered? (2/ 6) I m plem entation phasing plan July 2 0 1 2 Q1 – Q2 2 0 1 1 Q3 2 0 1 1 – Q3 2 0 1 2 Phase I Phase I I - Technical contribution to EC -Docum entation draft im plem enting - Good Vigilance Practice and other guidelines update m easures -Concept papers -Docum entation - First round of - Additional Business Process Mapping w orkshops update Business Process - Standard Operating Procedures, W orking Mapping I nstructions, Tem plates -I CT tools -I T requirem ents - I CT tools m aintenance 8
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
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
2. What will be delivered? (5/ 6) Several Concept Papers under preparation • Pharmacovigilance audits • Coordination of safety announcements • EU medicines Web-portal • Products under additional monitoring • Public hearings • Transparency • Etc,… . 11
2. What will be delivered? (6/ 6) Structure of im plem enting m easures and Good Vigilance Practice: ‘GVP’ EC I m plem enting m easures MAH MSs EMA Quality System Quality System Quality System - Task 1 - Task 1 - Task 1 - Task 2 - Task 2 - Task 2 ‘May’ - Task 3 - Task 3 - Task 3 Efficacy - Task n… - Task n… - Task n… Studies Terms, EV data ADR format PSUR format RMP format PASS format PSMF Formats, monitoring & content & content & content & content Standards Good Vigilance Practice guidelines MAH MSs EMA Quality System Quality System Quality System Detailed Detailed Detailed guidance guidance guidance Processes e.g Signal Effectiveness ADR Literature Detection & PASS RMP of risk Audit Inspection PSUR PAES reporting monitoring management minimisation Website Special Decision Safety Special Referrals Content & Products making announcement Population maintenance 12 12
Any questions? 13
List of abbreviations SOP : Standard Operating Procedure ERMS-FG : European Risk Management Strategy – Facilitation Group W I N : Working Instruction PSUR : Periodic Safety Update Report I CT : Information and Communication Technology ADR : Adverse Drug Reaction EMA : European Medicines Agency RMP/ S : Risk Management Plan/ System MSs : Member States EV : EudraVigilance PAE/ SS : Post-Authorisation Efficacy/ Safety Studies 14
Recommend
More recommend
