Product Safety Management
Risk management
The EMEA and FDA directives associated with risk management are continually updated:
- Volume 9-A
- CIOMS VI and VII (risk management during clinical trials)
- ICH “Pharmaceutical Quality System” (May 2007). Including DSUR
- ICH Q9-Q10
Product Life Consulting division - Areas of expertise
By remaining continuously updated on the latest technological advances, Product Life provides the keys required to help its clients to understand and interpret the new directives and regulations, in accordance with each client's specific requirements. We also help our clients to put in place the necessary governance in order to integrate medical risk management at the organisational level with the relevant information systems based on the two key areas of commitment and compliance.
Our network of consultants and experts can work with you in the following functional areas:
- R&D: pharmacovigilance, regulatory, (pharma) epidemiology, including clinical and non-clinical fields, technical development for the draft of risk management procedures
- Quality assurance: implementation of a quality assurance system spanning the entire lifecycle of a medical product
- IT: standardisation and validation of information systems
- Communication and Legal Affairs.
Our in-depth knowledge of the software applications available on the market also allows us to act as purchasing advisors for pharmacovigilance and signal analysis tools (quality and quantity-based).
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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