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Pharmacovigilance
Pharmacovigilance is the science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines with the aim of :
- Improving public health care and patient safety in relation to the use of medicines
- Contributing to the assessment of benefit, harm, effectiveness and risk of medicines
- Encouraging safer, rational and more effective use of medicines
Ivowen Limited provides range of post-marketing pharmacovigilance services for marketing authorisation holders such as:
- Appoint QPPV (Qualified Person Responsible for Pharmacovigilance)
- Register your company in EudraVigilance
- Management of pharmacovigilance data
- Processing of case data
- Reporting via EudraVigilance
- Literature searching
- Preparation of PSURs
- Evaluation of Safety Data
- Preparation of the Pharmacovigilance System Master file (set to replace the Detailed Description of Pharmacovigilance)
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