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Contact info

Sandra van der Poel - Smet
T: +31 (0)71 524 40 00
E: mail@vigilex.com

Inspection Preparedness

Over the past years, competent authorities have increased and intensified their regulatory inspections.

As support to clients during their preparation for these inspections, Vigilex has developed proven concept for inspection preparedness training.
This training is usually conducted in-house and aims to ensure that staff are aware what is expected during interviews and how to conduct themselves during an inspection.

Inspection preparedness training may include mock interviews aiming at the preparation for and familiarisation of the clients staff with the ins and outs of pharmacovigilance inspections by competent authorities.
During the training, information will be provided about how to individually prepare for an inspection in terms of issues and questions to be anticipated and how to relate to them in the context of individual tasks and responsibilities.
The mock interviews will be conducted by Vigilex lead auditors to mimic the situation during the inspection and obtain the best results.