A national agencys views Sabine Straus Sabine Straus MD PhD - - PowerPoint PPT Presentation

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A national agencys views Sabine Straus Sabine Straus MD PhD - - PowerPoint PPT Presentation

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The new pharmacovigilance legislation A national agencys views Sabine Straus Sabine Straus MD PhD Medicines Evaluation Board September 27, 2013 0 London 27-09-2013 Introduction Challenges for a NCA Some lessons learned

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London 27-09-2013

A national agency’s views

Sabine Straus

Sabine Straus MD PhD Medicines Evaluation Board September 27, 2013

The new pharmacovigilance legislation

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London 27-09-2013 1

  • Introduction
  • Challenges for a NCA
  • Some lessons learned
  • Closing remarks
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Firstly, public health activities Secondly, transparency and com m unication activities Thirdly, sim plification and efficiency activities

London 27-09-2013 * agreed by EMA Management Board

Prioritised implementation*

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Dr Peter Arlett, nov 12, 2012

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Actions taken at national level

  • I nternal

– Steering group – Working groups – Review/ update SOPs – Training

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  • External

– Stakeholder meetings – Patient/ HCP organisations meetings

  • Support

– dedicated website

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  • Introduction
  • Challenges for a NCA
  • Some lessons learned
  • Closing remarks

Signal detection Referrals Risk Management Plans

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Implementing Regulation No 520/ 2012 CHAPTER III provides details on operational aspects for minimum requirements for the monitoring of data in the EV:

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Art 18 General Requirements ⇒ EV monitoring Art 19 Identification of changed risks and new risks ⇒ Signals Art 20 Methodology for determining the evidentiary value of a signal ⇒ Validation Art 21 Signal Management ⇒ Stakeholders Art 22 Work-sharing for signal management ⇒ Public list of substances Art 23 Signal detection support ⇒ eRMR Art 24 Signal detection audit trail ⇒ EPITT & locally

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Signal detection Validation Confirm atio n Analysis, prioritizatio n Assessm ent Recom m endation for action

MAH MSs Agency MSs Agency

Signal Management Process IR art 21

PRAC

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Signal detection Referrals Risk Management Plans Transparancy

In practice

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Tracking & audittrail non-validated signals IR Art 24(1)]

I n practice at MEB

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Excel based summary data

  • Contain all Drug Event Combinations for a substance
  • Counts against different criteria, eg
  • literature
  • parent-child
  • fatal
  • source (Patient, Health Care Professional, Study..)
  • route of administration
  • pediatric, geriatric
  • abuse, medication error
  • PRR based disproportionality
  • Highlighted Signals of Disproportionate Reporting

Electronic Reaction Monitoring Report (eRMR)

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Electronic Reaction Monitoring Report (eRMR)

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Periodicity EudraVigilance monitoring

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Frequency proportionate to:

  • identified risk
  • potential risks
  • need for additional information

Baseline periodicity: once monthly 2 week frequency:

  • products under additional monitoring
  • products with need for additional information

More frequent in specific situations e.g. Pandemic situation, targeted safety issues

London 27-09-2013

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validation meeting

Week 1 Week 2 consult NL-PRAC delegates

e-RMR

? ?

EV Monitoring at Medicines Evaluation Board

meeting

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consistent, timely, traceable

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Signal confirm ation I X.C.1 . Roles and responsibilities E-mail: “Signal from … to …”

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Signals: Data and PRAC Outcomes

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  • Period: September 2012 - August 2013
  • 1 54 for CAPs (59% ), 29 for NAPs (31% ), 9 for both (10% )
  • 2 6 referrals ongoing, 2 concluded: restriction of use (codeine) and suspension of MA (HES)

Data source 51 EudraVigilance 19 national review 9 literature 4 FDA/ PMDA 4 historical (PhVWP) 5 studies Outcom e 44 labelling changes 12 no regulatory action 8 referral evaluation2 1 update RMP 27 assessment ongoing

Num ber of signals 921

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  • Introduction
  • Challenges for a NCA
  • Some lessons learned
  • Closing remarks

Signal detection Referrals Risk Management Plans Referral Procedures: Art 2 0 , Art 3 1 and Urgent Union Procedure ( 1 0 7 i) ,

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Time (hours)

Activity EU referral National actions Management 22 60 Case management 124,75 72,5 Assessment 564 58,5 PRAC 113 9 CMD-h 18,5 Policy advise 25,75 Public relations 48,5 416,5 Total 8 9 0 ,7 5 6 4 2 ,2 5

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  • Introduction
  • Challenges for a NCA
  • Some lessons learned
  • Closing remarks

Signal detection Referrals Risk Management Plans

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PRAC rapporteur PRAC Co- rapporteur PRAC Concerned CHMP rapporteur CHMP Co- rapporteur CHMP Peer CHMP Concerned

DUAL Rapporteurship

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RMP assessment principles (1/ 2)

  • Both CHMP and PRAC Rapporteurs start

assessing the dossier at Day 0

  • CHMP Rapporteur’s draft AR circulated first
  • PRAC Rapporteur considers CHMP draft AR

and circulates the draft RMP AR

  • Peer review and MS comments (PRAC +

CHMP)

  • PRAC RMP AR updated (AR template

designed for the process; one single document concept)

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PRAC – CHMP interaction timeline Opinion

D181: MAH sends responses to LOI

D181

D210 Opinion CHMP week PRAC week

D182-3: PRAC Rapporteur circulates the RMP AR D196: PRAC adopts the final PRAC Assessment Overview and Advice D210: CHMP adopts the CHMP AR and Opinion

<1 week

Member States comments D189: CHMP Rapporteur circulates the draft CHMP AR+

+7 +14 +21

2 weeks

RMP PRAC TC*

<1 week

* I f there is disagreement between PRAC and CHMP on the RMP assessment and recommendations

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  • Introduction
  • Challenges for a NCA
  • Some lessons learned
  • Closing remarks
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Science/Quality – Procedures Transparancy -communication Workload

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The new EU PV Legislation: Finding the right balance between procedures and contents

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Transparancy -communication

DIA Amsterdam 2013: Transparancy is there , but has communication improved

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  • W orkload

Challenges for the MEB

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  • Introduction
  • Challenges for a NCA
  • Some lessons learned
  • Closing remarks
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The ultim ate test for pharm acovigilance system s is the dem onstration of public health benefit

w ith the em erging pharm acovigilance tools and new legislative provisions, w e should be able not

  • nly to refine benefit– risk assessm ents, but also

to m axim ize the public health benefit of new m edical treatm ents.

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Closing rem arks

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