Good Vigilance Practice Modules I-IV PV quality assurance and control

Transcription

1 Good Vigilance Pracice Modules I-IV PV qualiy assurance and conrol Fergus Sweeney, PhD, European Medicines Agency Head, Compliance and Inspecions EU 28: Science, Medicines, Healh Dubrovnik, Croaia, 6-7 May 2013 An agency of he European Union

2 Pharmacovigilance risk benefi monioring cycle Observe Repor Monior Analyse Evaluae - Ac Paien Paien Healh Care professional MAH Regulaor

3 Pharmacovigilance P P a a i i e e n n Healhcare professional

4 P a i e n Pharmacovigilance PV and Qualiy Sysem Of MAH Of NCA/EMA Healhcare professional P a i e n

5 P a i e n Pharmacovigilance PV and Qualiy Sysem Of MAH Of NCA/EMA Inspecion By NCAs of MAH sysems PSMF Of MAH Audi By MAH of MAH PV sysem By NCA/EMA of heir PV Sysem P a i e n Healhcare professional

6 Pharmacovigilance All GVPs P a PV and Qualiy Sysem Of MAH Of NCA/EMA GVP I PSMF Of MAH GVP II P a i i e n Inspecion By NCAs of MAH sysems GVP III Audi By MAH of MAH PV sysem By NCA/EMA of heir PV Sysem GVP IV e n Healhcare professional

7 GVP I Pharmacovigilance sysem and is qualiy sysem

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9 Pharmacovigilance (phv) sysem A sysem used by an organisaion o fulfil is legal asks and responsibiliies in relaion o pharmacovigilance and designed o monior he safey of auhorised medicinal producs and deec any change o heir risk-benefi balance

10 Guidance for he esablishmen and mainenance of qualiy assured pharmacovigilance sysems: Markeing auhorisaion holders Compeen Auhoriies of Member Saes European Medicines Agency Describes general applicaion of qualiy managemen o pharmacovigilance sysems and requiremens specific o he operaion of he EU nework

11 Take home message: Qualiy sysem is o assure he inegriy of he pharmacovigilance sysem and is an inegral par of he pharmacovigilance sysem Produce visibly good pharmacovigilance Public healh Overall confidence Public rus 1

12 GVP II Pharmacovigilance Sysem Maser File

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14 Pharmacovigilance Sysem Maser File PSMF One MAH = one or more medicinal producs = one PV Sysem = one PSMF = one QPPV One PSMF = one locaion in EU = declared in Ar 57 daabase and in summary of pharmacovigilance in he dossier A uniform informaion se describing he pharmacovigilance sysem is available o he QPPV and for he purposes of audi. Tool for MAH and QPPV o oversee and manage PV sysem. Held and mainained by he MAH (no in dossier) To be made available immediaely on reques o auhoriies - A pracical reference for inspecion and assessmen. Oversigh based on periodic inspecion.

15 Module II PSMF, Informaion conained in he PSMF QPPV deails Producs Organisaional srucure Sources of safey daa Compuerised sysems and daabases Processing of safey daa PV sysem performance Qualiy Sysem Annexes (liss)

16 GVP IV Pharmacovigilance Audi

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18 TASKS AHEAD EMA and NCA and HMA is o pu in place an audi eams which adop a sraegic mind-se o respond o risk and ready o deliver audi repors in line wih he legislaive requiremens FIRST AUDIT repors of he pharmacovigilance sysem audi needs o be ready ( EMA- IV Q.2013, NCA s-21 Sepember 2013). EC shall make public a repor on he performance : -EMA-by 2 January NCA s -21 July 2015 MAHs mus have an audi programme for all new producs Auhorised since July 2012 and for all exising producs A he ime of implemenaion of he PSMF and no laer Than July 2015

19 GVP III Pharmacovigilance Inspecion

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21 GVP Module III Pharmacovigilance inspecions Table of conens: III.B. Srucures and processes III.B.1. Inspecion ypes III.B.1.1. Sysem and produc-relaed inspecions III.B.1.2. Rouine and for cause pharmacovigilance inspecions III.B.1.3. Pre-auhorisaion inspecions III.B.1.4. Pos-auhorisaion inspecions III.B.1.5. Announced and unannounced inspecions III.B.1.6. Re-inspecions III.B.1.7. Remoe inspecions

22 GVP Module III Pharmacovigilance inspecions III.B.2. Inspecion planning III.B.3. Sies o be inspeced III.B.4. Inspecion scope III.B.4.1 Rouine pharmacovigilance inspecions III.B.4.2 For cause inspecions III.B.4.3 Re-inspecions III.B.5. Inspecion process III.B.6. Inspecion follow-up III.B.7. Regulaory acions and sancions III.B.8. Record managemen and archiving III.B.9. Qualificaion and raining of inspecors III.B.10. Qualiy managemen of phv inspecion process

23 GVP Module III Pharmacovigilance inspecions III.C. Operaion of he EU nework III.C.1. Sharing of informaion III.C.2. Role of he European Medicines Agency III.C.2.1. General Role of he Agency III.C.2.2. Role of he PRAC III.C.2.3. Role of he CHMP III.C.2.4. Role of he CMD(h) III.C.3. Role of he Member Saes III.C.4. Role of he Markeing Auhorisaion Holders and Applicans III.C.5. Inspecion Fees III.C.6. Transparency

24 PhV Inspecors Working Group

25 PhV Inspecors Working Group PhV IWG formed in 2008 Mees Quarerly a he Agency Human and Veerinary medicinal producs Delegaes from 30 EU/EEA member saes agencies responsible for inspecion H + V Pre-accession - Croaia, Observers from Bosnia-Herzegovina, FYRM, Kosovo, Serbia, Turkey and Swizerland.

26 Objecives PhV Inspecors Working Group Harmonisaion hrough pracice Shared experience, discussion, conclusion Policy/guidelines/SOPs developmen Nework of conac beween inspecors Join inspecions on mos Cenralised inspecions Secion on he Agency s websie work programme and annual repor from he group: hp://

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28 A parnership approach Presenaion ile (o edi, click View > Header and Fooer)

29 Vigilance Harmonisaion Informaion sharing and analysis Planning, conduc and follow-up Coheren and responsive sysems EMA NCAs Inspecors Assessors MAH Healhcare Professional All working o serve and proec Paiens Thank you