| Goals / remit of the organisation: |
EP Consultants provide the pharmaceutical companies expertise and experience of senior consultants in the field of pharmacovigilance and risk management:
- Advice and expertise in pharmacovigilance system (implementation of PV system, optimization of the Pharmacovigilance system Master File (PSMF), audit, preparation of European inspections)
- Advice and expertise in risk management systems (writing RMP, answers to questions from European authorities)
- Medical expertise (type II variation, PSURs, DSURs, safety part of MAA)
- Regulatory assitance
- Training on PV texts
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