Good Pharm acovigilance Practices ( GVP) 3 rd Stakeholders Meeting - - PowerPoint PPT Presentation

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Good Pharm acovigilance Practices ( GVP) 3 rd Stakeholders Meeting - - PowerPoint PPT Presentation

Oct 06, 2022 382 likes •511 views

Good Pharm acovigilance Practices ( GVP) 3 rd Stakeholders Meeting on the new pharmacovigilance legislation Presented by: Priya Bahri (EMA) and Patricia Moore (MHRA) An agency of the European Union Scope Self-standing guidance on

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An agency of the European Union

Presented by: Priya Bahri (EMA) and Patricia Moore (MHRA)

Good Pharm acovigilance Practices ( GVP)

3rd Stakeholders Meeting on the new pharmacovigilance legislation

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Priya Bahri and Patricia Moore: GVP 2

  • Self-standing guidance on pharmacovigilance

processes

  • Compliance with legal tasks and responsibilities
  • Addressed to EU marketing authorisation

holders, competent authorities in Member States and Agency

  • Participation of patients and healthcare

professionals

  • Replaces Volume 9A in the future

Scope

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Priya Bahri and Patricia Moore: GVP 3

  • Governance structure
  • EMA-Member States Project Teams
  • Consideration to stakeholder expectations

(experience, PCWP, HCPWG, non-EU regulators, conferences, publications… )

  • Internal consultations (PhVWP, PhVIWG, CHMP,

CMD(h), PCWP… )

  • Public consultation

GVP development process

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Priya Bahri and Patricia Moore: GVP Priya Bahri and Patricia Moore: GVP 4

  • Ongoing
  • 2 waves
  • 1st wave to be released for public consultation

early 2012  final in mid-2012

  • 2nd wave to be released for public consultation

later in 2012  final as of end 2012

GVP development status

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SLIDE 5

Priya Bahri and Patricia Moore: GVP 5

I PhV Systems and their Quality Systems I I PhV System Master File V Risk Management Systems VI Individual Case Safety Reports VI I Periodic Safety Update Reports VI I I Post-Authorisation Safety Studies X Signals

GVP structure by modules - 1st wave

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SLIDE 6

Priya Bahri and Patricia Moore: GVP

GVP structure by modules – 2nd wave

  • Audits
  • Inspections
  • Additional

monitoring

  • Public participation
  • Communication
  • Continuous phv and

regulatory action

  • Referrals / Union

procedures

  • Effectiveness of risk

minimisation

  • Incident management
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Priya Bahri and Patricia Moore: GVP Priya Bahri: PhV QS 7

  • Annex for definitions
  • Annex for ICH guidelines
  • Considerations: chapters for product-

and population-specific guidelines

GVP annexes and considerations

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Priya Bahri and Patricia Moore: GVP Priya Bahri and Patricia Moore: GVP 8

A – Introduction B – Structures and processes C – Operation of the EU network

Structure within modules

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Priya Bahri and Patricia Moore: GVP

Transparency in GVP

  • Committed to transparency in

pharmacovigilance

  • Process-specific transparency provisions in each

GVP Module

  • E.g. assessment reports, committee outcomes,

RMP summaries

  • Web portal
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Priya Bahri and Patricia Moore: GVP

Public participation in GVP

  • Dedicated GVP Module
  • Public hearings
  • Patient and healthcare professionals as PRAC

Members and ad hoc experts

  • Input from PCWP (patients working party) and

HCPWG (healthcare professionals working group) on e.g. risk minimisation and communication

  • Adverse reaction reporting
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SLIDE 11

Priya Bahri and Patricia Moore: GVP

Prepare for 1st wave public consultation

February … .. March 2012