Product safety management
Monday 07 March 2011 Pharmacovigilance: Setup of a Euro compliant PV system
In the scope of a BioPharma entity setup, support in the design, implementation and roll out of the PV system, worldwide and compliant with the European regulations.
CLIENT
Main player in Medical Device industry, worldwide established, setting up a BioPharma entity.
CONTEXT
In the scope of the BioPharma entity setup, support in the design, implementation and roll out of the PV system, worldwide and compliant with the European regulations.
OBJECTIVES
Setup of a PV system, fully compliant with European Regulations, under the responsibility of the MAH (the BioPharma entity) and covering all medical products issued by all Business Units, on a worldwide basis.
ORGANIZATION OF THE MISSION
Phase 1: Support to the Setup of a PV system, with an In-sourced QPPV:
- Setup of the PV System in terms of Processes, Teams, SOPs, Quality System.
- Liaison with partners, services and software providers, internal teams (RA, QA, MA) and existing Medical Device Teams.
- Design and implementation of the (outsourced) “Assigned PV Center”, including the interfaces with the internal teams.
- Liaison with former MAH for the transfer of the PV activities.
- Change Management for transitioning from the Medical Device culture to the Pharmacovigilance culture.
- In terms of structure:
- The “Assigned Product Complaint Centre” is internal and is in charge of collecting the relevant the Safety Information and performing its follow-up.
- The “Assigned PV Center” is external and is in charge of the qualification, entry, assessment and expedited reporting of the Safety Information.
Phase 2: Finalisation of the PV system, with an Out-Sourced QPPV:
- Finalisation of the PV System setup.
- QPPV and Deputy QPPV (outsourced).
- Coaching of a new internal PV resource to take over all previously launched activities.
RESOURCES
- 1 FTE senior consultant with a Project Management profile, on an “in-sourcing” basis during 1 year.
- 0.5 FTE expert consultant with Business PV profile and / or Medically Qualified Persons including the roles of the QPPV and the Deputy QPPV, on an “out-sourcing” basis during 6 months.
RESULTS
A PV system fully set up and operational with a DDPS and a QPPV, ready for the MAH application.
Product Complaint Management Teams ready to deal with Pharmacovigilance constraints.
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