The new Pharmacovigilance legislation and implementation planning - - PowerPoint PPT Presentation

An agency of the European Union

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

1

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;

2

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

3

• 1. Governance – EU Network (2/ 5)

Project Oversight Committee (ERMS-FG) Project Coordination Group

EMA/ MSs Project Team 1

• Audit/

Inspections EMA/ MSs Project Team 2 PSURs EMA/ MSs Project Team 3 ADR reporting / Additional Monitoring/

• Signals

EMA/ MSs Project Team 4

• RMP/

PASS/ PAES

• Effectiveness
• f risk

Minimisation EMA/ MSs Project Team 5

• Committees/

Referrals EMA/ MSs Project Team 6

• Communica-

tion/ Transparency

12 EMA Subproject Teams

PSUR PASS/ PAES Product Info. EV/ ADR rep. Committees Referrals Fees Com./ Transp

• Lit. monit/

Signal detect.

Insp./ PhV sy. RMS PhV audits

6 EMA/ MSs Project Teams

EMA Task- Force

ICT Group

4

• 1. Governance – working methodology (3/ 5)

Subproject Teams Project Teams

Issue Log Actions Table Tracking Table Concept Paper Impl. Meas. Status Report Concept Paper Impl. Meas.

Project Coordination Group

Tracking Table Actions Table

Project Oversight ERMS FG

Concept Paper Concept Paper Impl. Meas. Impl. Meas.

Drafted Drafted/ Agreed Adopted Adopted

Issue Log Status Report Status Report

Heads

• f Medicines

Agencies

Concept Paper Impl. Meas.

Informed Subproject Teams Project Teams

Issue Log Actions Table Tracking Table Concept Paper Impl. Meas. Status Report Concept Paper Impl. Meas.

Project Coordination Group

Tracking Table Actions Table

Project Oversight ERMS FG

Concept Paper Concept Paper Impl. Meas. Impl. Meas.

Drafted Drafted/ Agreed Adopted Adopted

Issue Log Status Report Status Report

Heads

• f Medicines

Agencies

Concept Paper Impl. Meas.

Informed

5

• 1. Governance – Reporting timelines (4/ 5)

Friday 2 weeks before CHMP Friday Week before CHMP W ednesday CHMP week W ednesday Week after CHMP Subproject Teams submit Status Report Project Teams submit Status Report Project Coord. Group submits Status Report to ERMS FG Project Coord. Group meets to review Status Reports

6

• 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

7

• 2. What will be delivered?(1/ 6)

Hierarchy of rules

• Regulation (EC) 1235/ 2010
• Directive 2010/ 84/ EC

EC I m plem enting Measures = Commission regulation (Reg. Art. 87a and Dir.Art.108

• Policies
• Operations
• I CT

Concept Papers I T requirem ents Process Mapping EMA/ MSs Technical contribution Guidelines SOP/ WIN/ Templates IT tools

Deliverables

8

• 2. What will be delivered? (2/ 6)

Q1 – Q2 2 0 1 1 Phase I Q3 2 0 1 1 – Q3 2 0 1 2 Phase I I

• First round of

Business Process Mapping

• I T requirem ents
• Technical

contribution to EC draft im plem enting m easures

• Concept papers
• Good Vigilance Practice and other guidelines
• Additional Business Process Mapping w orkshops
• Standard Operating Procedures, W orking

I nstructions, Tem plates

• I CT tools

July 2 0 1 2

• Docum entation

update

• Docum entation

update

• I CT tools

m aintenance

I m plem entation phasing plan

9

• 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;

10

• 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;

11

• 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,…

.

12 12

Structure of im plem enting m easures and Good Vigilance Practice: ‘GVP’

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…

‘May’ Efficacy Studies

PSMF Terms, Formats, Standards EV data monitoring ADR format & content PSUR format & content RMP format & content PASS format & content

MAH Quality System Detailed guidance MSs Quality System Detailed guidance EMA Quality System Detailed guidance

Audit Inspection PSUR ADR reporting Literature monitoring PAES PASS RMP Effectiveness

• f risk

minimisation Decision making Referrals Safety announcement Website Content & maintenance

Good Vigilance Practice guidelines EC I m plem enting m easures

Special Products Special Population Processes e.g Signal Detection & management

• 2. What will be delivered? (6/ 6)

13

Any questions?

14

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 PAE/ SS: Post-Authorisation Efficacy/ Safety Studies

SOP: Standard Operating Procedure W I N: Working Instruction I CT: Information and Communication Technology EMA: European Medicines Agency MSs: Member States