Dossier preparation, production, submission and maintenance
Friday 04 March 2011 Data management: analysis and extraction of data
Achieving compliance with the European Pediatric Regulation requires the compilation of the pediatric effects described in the marketing authorizations 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 Pediatric Regulation concerning the pediatric effects of medicines.
OBJECTIVES
To ensure the compliance of the Client’s operations with a major regulatory evolution.
ORGANIZATION OF THE MISSION
In the context of achieving compliance with the European Pediatric Regulation, regarding the methodology applied and using all the necessary IT tools, the task was as follows :
- Compiling the existing of clinical studies.
- Checking that the studies had been submitted to the relevant regulatory authorities.
- Checking the existence of pediatric mentions in the product characteristic summaries.
- Creating a link between these mentions and the studies.This was to be done for all the Clients’ marketing authorizations in the 30 countries concerned.
RESOURCES ALLOCATED
2 scientific post graduate skilled in foreign languages, on an “in-sourcing” bases during 6 months.
RESULTS
The compliance of the Client’s RA database with the European Pediatric Population.
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