Product Safety Management
Monday 07 March 2011 Pharmacovigilance: Introducing a "proactive safety" step
ProductLife assists the Pharmacovigilance and Risk Management Departments of a major pharmaceutical laboratory, in the introduction of a process for preventing medical risks associated with pharmaceutical products.
CLIENT
A major pharmaceutical laboratory, Pharmcovigilance Department and Risk Management Department.
CONTEXT
In addition to the Pharmacovigilance system, the Volume 9A requirements, which place the stress on a proactive prevention procedure for medical risks associated with pharmaceutical products for human use.
Three axes of development:
- To master and develop knowledge of product “safety”.
- To introduce necessary plans for “post-marketing” risk management, but also to anticipate a similar process (DRMP) during the development phase.
- To extend vigilance through research / evaluation of signals in internal and external databases (e.g. FDA, Eudravigilance, WHO), and also systematic bibliographical researches.
OBJECTIVES
To frame all the above axes of development within a pragmatic project staged in terms of time, driven by the most pressing requirements, and adapted to the means of the business. The framing phase, carried out by ProductLife, led to two objectives in parallel :
- To introduce signal analysis and bibliographical research systems.
- To formalize the processes for compiling and implementing risk management plans.
ORGANIZATION OF THE MISSION
Analysis of current practices / tools versus the requirements for signal analysis and bibliography.
Schedule of Conditions and Invitation to Tender.
Change management :
- Leading of working groups to formalize the processes linked to the risk management plans.
- Definition of key indicators for measuring progress associated with implementation of these processes.
- Pilot introduction.
RESOURCES
1 Project manager, 1 senior consultant and 1 experienced consultant, + 1 Pharmacovigilance expert.
The full task has been divided into a number of “sub-tasks”, with a load charge of approximately 100 person-days, all profiles combined.
RESULTS
- Introduction of risk management plan processes is in the final phase.
- The introduction of the signal analysis system is in progress.
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