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Friday 09 July 2010

Business Cases

Data management: Analysis and extraction of data Tuesday 03 March 2009

Achieving compliance with the European Paediatric Regulation requires the compilation of the paediatric effects described in the marketing authorisations for all the medicines. The highly demanding timetable has forced certain laboratories to create a veritable task force.

Client:

A world leader in the pharmaceutical sector, R&D department (regulatory affairs).

 

Context:

To respond to the obligations arising from the new European Paediatric Regulation concerning the paediatric effects of medicines.

 

Objective:

To ensure the compliance of the clients’ operations with major regulatory developments.

 

Organisation of the task:

In the context of achieving compliance with the European Paediatric Regulation, and with respect for the methodology applied and using all the necessary computer applications and tools, the task was as follows:

• To compile an inventory of clinical studies.

• To verify whether these studies had been submitted to the competent regulatory authorities.

• To verify the existence of paediatric mentions in the product characteristic summaries.

• To create a link between these mentions and the studies.

This is for all the client’s marketing authorisations in the 30 countries concerned.

 

Resources applied:

2 Bac+5 diploma holders in foreign languages and scientific training in “in-sourcing” for 6 months.

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