(Highlights from the ENCePP Plenary Meeting, 24 November 2015)
Xavier Kurz set the scene by presenting a brief introduction highlighting ENCePP’s potential role and contribution so far to the regulatory need for continuous monitoring and investigation of benefit/risk profiles of medicines.
- Scenario 1: Proposal for a Central Mechanism for Industry-Funded Studies (Tom MacDonald)
- Scenario 2: Proposal on Medication Safety in Pregnancy (Helen Dolk)
- Scenario 3: Different Governance Models for Collaborative Vaccine Studies Based on the Work of the ADVANCE Project (Xavier Kurz)
Discussion and Way Forward
In conclusion, Miriam Sturkenboom and Alison Bourke summarised the discussions as follows:
- The ENCePP Code of Conduct and its provisions regarding independence and industry stakeholder involvement remain current and helpful.
- It was agreed that funding should come from industry, but administered by an independent organisation; different options need to be explored further.
- In addition, in order to secure independent/public funding in the future, ENCePP should make use of its collective influence and make the case at European level. Setting up a virtual group is proposed.Peter Arlett confirmed that the outcome of the discussions will be furthered at Steering Group level at its meeting on 16th December 2015.