Business Cases
Friday 11 March 2011 Regulatory Affairs: Data Quality Management
The marketing of medicinal products in over 100 countries involves a rigorous und updated follow-up of the global Regulatory Affairs activity.
CLIENT
The international Regulatory Affairs department of a global pharmaceutical leader.
CONTEXT
Monitoring, enriching and validating a centralized database dedicated to following the Regulatory Affairs activity of the Industrial entity with the authorities of more than 100 countries.
OBJECTIVES
In accordance with the rules implemented by the client, entering the data of diverse documents (sent mails, official documents received from the health authorities, activity reports received from the international Regulatory Affairs contacts of the client…) into the follow-up database.
Archiving the documents according to the procedures implemented by the client.
ORGANIZATION OF THE MISSION
- Collecting at a global level all the necessary information from the different stakeholders in order to consolidate, update and validate the data appearing in the database.
- Filing of the dossiers.
RESOURCES
- 3 persons with a Masters degree experienced in Regulatory Affairs support for a period of 2 years at the client´s site.
- Time to set up the mission: 4 months.
RESULTS
- Ongoing mission.
- Full satisfaction of the client expressed during the meetings organised to assess the state of progress of the mission.
- Deadlines respected.
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