The scientific and medical literature is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.
Marketing authorisation holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week.
In addition, marketing authorisation holders should have procedures in place to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorisation.
Reports of suspected adverse reactions from the scientific and medical literature, including relevant published abstracts from meetings and draft manuscripts, should be reviewed and assessed by marketing authorisation holders to identify and record ICSRs originating from spontaneous reports or non-interventional post-authorisation studies.
Revipharm can help you, monitoring scientific literature.
For more information please contact us at: info@revipharm.es
Other related links:
Update date: 14-04-2015
- Pharmacovigilance system master file
- Pharmacovigilance audits
- Qualified person responsible for pharmacovigilance in the EU
- Pharmacovigilance responsibilities of the MAH at EU
- Safety Data Exchange Agreements (SDEAs)
- Persona de contacto de Farmacovigilancia en España
Revipharm puede realizar un seguimiento de la bibliografía científica mundial, con el fin de identificar los casos de sospechas de reacciones adversas asociadas a un principio activo de un medicamento del que sea titular en España ocurridas en la Unión Europea
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