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
- 20 April 2023
European Medicines Agency (EMA) strengthens PRIME (Priority Medicines) with new features
- 24 March 2023
The implementation of the European regulation on medical devices
- 13 March 2023
Forthcoming changes to accessing and managing EudraVigilance
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