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OUR EXPERTISE
Universal Medica is the preferred partner of healthcare stakeholders in the field of vigilance at local and global level. Our expertise extends to pharmacovigilance (Brand, generics, biosimilars), Materiovigilance, Cosmetovigilance, Nutrivigilance and Toxicovigilance, for parent companies or subsidiaries.
- Spontaneous and solicited case management
- Local and international literature watch (France, Europe, Africa, Asia)
- EudraVigilance : L2A request, MLM request, XEVMPD, EU QPPV registration and Trusted Deputy.
- Drafting of safety reports PSUR, PBRER, DSUR, ACO, periodic compassionate use reports and responses to requests from authorities
- Benefit/risk management: signal detection and management, risk management: drafting RMPs, implementation of Risk Reduction Plans and safety communication.
- Delegation of European Qualified Person for Pharmacovigilance (EU QPPV) and/or Local Qualified Person for Pharmacovigilance (LQPPV)
- Quality system in pharmacovigilance: support for audits and inspection, drafting and monitoring of PSMF, SDEA, procedures and training.
Vigilance Academy
A complete training modules for healthcare professionals in vigilance management: Pharmacovigilance, Materiovigilance , Cosmetovigilance , Nutrivigilance
News
- 11 May 2022
The European Union In Vitro Diagnostic Medical Devices Regulation (IVDR)
- 21 March 2022
Universal Medica Group acquires Zebra Santé
- 9 March 2022
How to qualify for orphan designation in the European Union?
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