Pharmacovigilance & Medical Devices

Updated 25 September 2018

Director of Division: Jens Piero Quartarolo, Send an email.

In the pharmacovigilance field, the division handles and analyses adverse reaction reports from citizens, doctors, other healthcare professionals and industry.  Causality assessments are made. The division operates the Drug Interaction Database, conducts signal generation in relation to the overall existing knowledge and works with risk minimisation. The Danish Pharmacovigilance Council offers advice on efforts.

In the medical devices field, the division carries out the tasks that the Danish Medicines Agency is responsible for as the competent Danish authority. This includes authorisation of clinical trials and market surveillance based on reports submitted by citizens, the health service and the medical device industry. The Medical Devices Committee offers advice on efforts.

In addition, the division investigates suspected illegal advertising of medicines, medical devices and health services.

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