Product Safety Management
Pharmacovigilance
Our activity in this area involves supporting our clients to implement risk management systems (processes and tools).
Increasing demands for transparency and changes in the guidelines for proactive risk management (vol. 9. A) and the electronic submission of identified cases have a significant impact both on pharmacovigilance practices and the associated information systems. These developments have forced laboratories and biotech companies to make significant changes.
Our consultants specialised in pharmacovigilance will help you to define a plan for change. This plan would involve the following key points:
- Defining signal management processes and continuous risk analysis,
- Implementing signal detection and risk management tools.
Our teams of specialists can also support you in outsourcing some or all of your tasks, thus enabling you to comply with Pharmacovigilance requirements and monitor your indicators more effectively and achieve operational efficiency quickly and easily.
See the following examples:
- Validated PV database
- Litterature searches, data compilation and analysis
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Preparation of dossiers and reports for submission to authorities (PSURs, etc.)
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Medical monitoring.
Download the following presentation of Erick GAUSSENS - CSO - "Risk management and the future of Pharmaco Vigilance" (English - 464 Ko)
Latest News
Monday 30.01.2012
Conférence à Paris: ProductLife participe à l'évènement sur la Cosmétovigilance organisé par la FEBEA
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Tuesday 24.01.2012
Kompaktseminar in Berlin: EVMPD - praktische Umsetzung bis Juli 2012
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Friday 20.01.2012
Petit-déjeuner à Paris: La gestion globale de l'information des produits pharmaceutiques
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