Countries: SLO, CRO, B&H, SRB, FYR Macedonia
The legislation on drug safety monitoring within the European Union has become more complex and extensive during the recent years. We can help Marketing Authorisation Holders to ensure that pharmacovigilance (PV) systems and procedures are properly established and that obligations to monitor the safety of marketed products are met.
We can offer:
- Advice on PV systems
- Development and implementation of PV system
- Regular literature searches
- Electronic or Paper based Reporting to EMEA and European Competent Authorities
- Preparation of Periodic Safety Update Reports, Summary Bridging Reports and Addendum Reports,
- Preparation of Risk Management Plan and advice on Risk Management System development
- Providing Qualified Person for Pharmacovigilance (QPPV)
- Providing Local Qualified Person/Representatives
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