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Business Cases

Pharmacovigilance: Introducing a "proactive safety" step Sunday 01 March 2009

ProductLife assists the Pharmacovigilance and Risk Management Departments in 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 where 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 research.

 

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 formalise the processes for compiling and implementing risk management plans

 

Organisation of task (after framing phase):

Analysis of current practices / tools versus the requirements for signal analysis and bibliography.

Schedule of Conditions and Invitation to Tender

• Leading of working groups to formalise the processes linked to the risk management plans.

• Definition of key indicators for measuring progress associated with implementation of these processes.

• Pilot introduction

 

Resources applied (including framing phase):

1 task manager, 1 senior consultant and 1 experienced consultant, + 1 Pharmacovigilance expert

The full task (as of now) has been divided into a number of “sub-tasks”, with a load charge to date, all profiles combined, of approximately 100 person-days.

 

Results:

• Introduction of risk management plan processes is in the final phase.

• The introduction of the signal analysis system is in progress.