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Work Package 8 – Lifecycle Pharmacovigilance

Work Package 8 explored existing standards for pharmacovigilance assessments and produced reports on best practice. The reports’ aims are to ensure that NCAs are able to support the Pharmacovigilance Risk Assessment Committee (PRAC) with high-quality assessment and advice on: risk management plans (RMPs), post authorisation studies (PASS), periodic safety update reports (PSURs) and referral procedures.

WP8 also examined the availability and use of additional (epidemiological) data sources for assessment in different European NCA settings. Through focusing on key risk management tools to establish current assessment practices, best practice guidance documents and training in use of these tools were prepared. Competency recommendations were created to contribute to the development of PV assessors’ competencies across the EU.


  1. Developing a competency framework to support exemplary pharmacovigilance throughout the product lifecycle.


Within Work Package 8, there were five individual topics which were working on:

  1. Identification of available data sources outside spontaneous reporting – lead: AIFA
  2. Risk Management Plan assessments – lead: NOMA
  3. Post Authorisation Safety (and Efficacy) Studies protocols and study reports – lead: MPA
  4. Benefit/risk assessment in the context of  PSUR and referral procedures - lead: AIFA
  5. Competency – lead: AIFA

Outputs and results

European Member States were asked to complete 5 surveys in order to identify their current methods in pharmacovigilance assessments. These surveys focused on: data sources (Topic 1), Risk Management Plans (Topic 2), Post-Authorisation Safety/Efficacy Studies (Topic 3), Periodic Safety Update Reports and referral procedures (Topic 4), and competency in PV (Topic 5). The results from these reports were used to construct training deliverables for SCOPE Work Package 8.

SCOPE WP8 Survey Report 2015

Training materials

WP8 delivered a series of best practice learning materials supplemented by a training workshop held in September 2017. Click here access WP8 learning materials.

Training on Lifecycle Pharmacovigilance

WP8 team led by the Italian Medicines Agency (AIFA) held a two-day training session on 20th-21st September 2016 in Lisbon. It was attended by participants from 26 member states. The training was designed to share experiences and practical advice on some specific aspects of benefit risk assessment.

Partners involved

AIFA leads on all of these topics with involvement of other partners. The other partners actively involved in WP8 are:

  • AEMPS (Spain)
  • INFARMED (Portugal)
  • HPRA (Ireland)
  • NOMA (Norway)
  • MPA (Sweden)
  • MHRA (UK)
Work Package 8 is examining pharmacovigilance assessments and will recommend best practices to support high-quality assessment and capability of the EU network
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