1. Helen Lee, European Commission
SCOPE Joint Action Stakeholder Event Working together and building on SCOPE to develop PhV further
Helen Lee, European Commission
March 2017
London

2. Outline of the presentation
Pharmacovigilance activities in the EU
SCOPE Joint Action - impact and sustainability

3. EU Pharmacovigilance - a network approach
Member States
European Medicines Agency including the Pharmacovigilance Risk Assessment Committee (PRAC)
European Commission

4. Advantages of the network approach
Transparency and early involvement
Bringing together multiple experts for the benefit of public health
Collaborative development of (scientific) guidelines taking account of the state-of-the-art
Facilitating communication with a variety of stakeholders including academia, patients and industry

5. Pharmacovigilance activities
pro-active risk management
monitoring of data on the safety of medicines
acting to protect public health
communication on risks

6. Report on Pharmacovigilance Activities
Report from the Commission and accompanying staff working document adopted 8 August 2016
Pharmacovigilance activities of Member States and the European Medicines Agency
July 2012 – December 2014

7. PRAC agenda items

8. PRAC agenda items

9. Member State activities
Total between July 2012 – December 2014 in 28 members of the network:
Risk management plans:
Periodic safety update reports:
Post authorisation safety studies: 17
Post authorisation efficacy studies: 1

10. Monitoring adverse drug reactions
Increasing number of reports
Patient reporting increased by around 50%

11. Signal detection sharing the work

12. PSUR assessments PRAC outcomes

13. Pharmacovigilance referrals
July 2012 – December 2014
6 urgent safety referrals (Art. 107i) for nationally authorised medicines
7 related to centrally authorised medicines only (Art. 20)
18 related to nationally or nationally and centrally authorised medicines (Art.31)

14. Communications and information
Information related to the PRAC – agendas, minutes
Public safety communications – e.g. concerning referrals
European database of suspected ADRs
European Network of Centres in Pharmacoepidemiology and Pharmacovigilance e.g. outcomes of imposed PASS
Risk management plan summaries

15. Challenges Different authorisation procedures
– central, national, MRP/DCP
The number of pharmacovigilance procedures and activities
– RMPs, signals, PSURs, referrals, communication, audits
Timelines for the assessment procedures
Identification and promotion of best practices across the network – improving quality, building capacity
Continuing development of best practice with experience

16. SCOPE working together
Healthcare professional
Patients
Regulatory authorities
Brilliant materials from SCOPE
EU NTC platform
Exchange Programme

17. Sustainability and impact are interlinked
KEY CHALLENGE - ensuring uptake and use of the deliverables
The action will impact pharmacovigilance practice ONLY if the tools are ACTUALLY USED by you
Embedding deliverables into EU system
Potential for added impact by raising awareness on the EU pharmacovigilance system

18. Questions? European Commission Public Health information: