A Quarterly journal researched and edited by an expert team experienced in all aspects of the safe use of medicines and medical devices.
PharmacoVigilance Review, is dedicated to the analysis of international regulations and informed comment on drug safety issues.
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- Review of the new role of the European Qualified Person
- Comparison of EU and US regulations
- Examination of the demands of pharmacovigilance inspections
- Understanding new guidelines on the Periodic Safety Updates Reports (PSUR)
- Debate on the effects of the Clinical Trials Directive
- Interpretation of the FDA's Risk Management Guidance
- Report on EMEA guideline on pharmacovigilance for paediatric medicines
- Discussion on the challenges of medical device vigilance
- Evaluation of the effects of Volume 9A on all matters of drug safety