Pharmacovigilance Systems Consulting provides pharmacovigilance consultancy services for the pharmaceutical and biopharmaceutical industry worldwide (EU/EEA, USA, Japan), across various therapeutic areas, including orphan drugs, to clients with products either authorised or under development.
ERIC CAUGANT MD
Founder of Pharmacovigilance Systems Consulting (PhVSC).
Expertise
Pharmacovigilance Systems Consulting provides pharmacovigilance consultancy services for the pharmaceutical and biopharmaceutical industry worldwide (EU/EEA, USA, Japan), across various therapeutic areas, including orphan drugs, to clients with products either authorised or under development.
Pharmacovigilance consultancy services consist of but are not limited to:
1.
Developing and maintaining Pharmacovigilance Systems and their Quality Systems
2.
Provision of Qualified Person Responsible for Pharmacovigilance (QPPV) and back-up (Deputy), in the EU
3.
Developing risk management systems and strategy
4.
Pharmacovigilance system master file
5.
Pharmacovigilance inspections and audits preparation and management
6.
Process review, gap analysis and improvement,
7.
Periodic Safety Update Report. Benefit-risk analysis
8.
Post-authorisation safety studies
9.
Signal management
10.
Safety communication
11.
Preparing Safety Data Exchange Agreements (SDEA/PVA)
12.
Providing ad hoc medical expertise and Pharmacovigilance trainings