First experiences: PRAC transparency 6 th Stakeholders forum on the - - PowerPoint PPT Presentation

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First experiences: PRAC transparency 6 th Stakeholders forum on the - - PowerPoint PPT Presentation

Nov 10, 2022 257 likes •507 views

First experiences: PRAC transparency 6 th Stakeholders forum on the implementation of the new pharmacovigilance legislation June M Raine Chair, Pharmacovigilance Risk Assessment Committee An agency of the European Union Outline of presentation

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An agency of the European Union

First experiences:

PRAC transparency

6th Stakeholders forum on the implementation of the new pharmacovigilance legislation

June M Raine Chair, Pharmacovigilance Risk Assessment Committee

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Outline of presentation

Where we have come from - legislative aims What is new - PRAC publications

  • agendas and minutes
  • safety communication
  • notification of referrals

How is it working - first experiences Where next - looking ahead

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Pharmacovigilance legislative aims

Strengthened Vigilance Efficiency & simplification Transparency & communications

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European Commission

Review 2006 found:

  • Low levels of transparency
  • Lack of inclusiveness of

stakeholders

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Transparency – first steps

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Publications from

Pharmacovigilance Working Party 2011

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Requests for access to pharmacovigilance documents

5 Dec 2006 - EMA Management Board Rules implementing Reg 1049/2001

  • n Access to documents

Publication first PhVWP Monthly Report

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Transparency- H1N1 vaccines

Regular publication of summary

ADR data and signals EMA published weekly summary of Eudravigilance data and signals Highlighted importance of transparency on emerging safety data

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Regulation (EU) No 1235/2010

Via a medicines web-portal the Agency shall make public inter alia (Art 26):

  • Agendas and minutes of each meeting of PRAC
  • Summary of risk management plans for CAPs
  • List of medicines subject to additional monitoring
  • Information about how to report to national competent

authorities suspected ADRs and standard web-forms

  • Initiation of procedures via Art 107i to 107k

– the active substances or medicinal products concerned – The issue being addressed – Any public hearings pursuant to the procedure – Information on how to submit information and to participate in public hearings

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European Medicines Web-portal

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PRAC publications to date 2012

Agendas – July, September, October, November Highlights - July, September, October, November Minutes - July, September, October Referrals – Codeine Article 31, Diclofenac Article 31 d

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PRAC publications - principles

Timeliness

  • Clear predictable timelines

Comprehensibility

  • Explanatory notes
  • Acronyms and abbreviations

Accessibility

  • EMA Web-portal
  • Linkages at national level
  • Ongoing development
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PRAC Publications timing schedule

Agenda Highlights Safety referrals Minutes

Day 1 of PRAC by mid-day Thursday of PRAC week Thursday of PRAC week Following month after adoption

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EMA Website Views and downloads

2000 4000 6000 8000 10000 12000

Draft Agenda: inaugural plenary meeting Jul 12 (18/07/12) Draft Agenda: meeting Sep 12 (03/09/12) PRAC elects chair and vice-chair (07/09/12) Draft Agenda: meeting Oct 12 (01/10/12) Draft Agenda: meeting Oct 12 (29/10/12) Minutes - inaugural plenary meeting Jul 12 (07/09/12) Minutes - PRAC meeting Sep 2012 (05/10/12) Meeting highlights from the PRAC Oct 12 (05/10/12) Codeine- containing medicines (05/10/12)

Document / page (date published by EMA)

  • No. views/downloads

Upper limit range views / downloads Minumum

  • No. views /

downloads

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Explanatory Notes Acronyms translated

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Safety communication

Art 106a 2001/83/EC

“For active substances contained in medicinal products authorised in more than one Member State the Agency shall be responsible for the coordination between national competent authorities of safety announcements Under the coordination of the Agency, the Member States shall make all reasonable efforts to agree on a common message The PRAC shall at the request of the Agency provide advice on those safety announcements”

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Looking ahead

Adding new resources

Summary RMPs, medicines under additional monitoring, public hearings

Promoting awareness

at national level – web-portals, co-

  • rdinating national communications,

“suite” of documents

Monitoring impact

  • n ADR reporting, better informed

prescribers, patients and public

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Summary

Transparency and communication on drug

safety is key to protection of public health Timely access to pharmacovigilance information and decisions is the basis of stakeholder engagement Commitment of PRAC already demonstrated via timely publication of agendas, highlights and minutes There is much more to come

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Pharmacovigilance Risk Assessment Committee

“All aspects of the risk management of the use of medicinal products including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicine”