Pharmacovigilance Services

The experienced pharmacovigilance team at Midas Pharma supports you sustainably and efficiently in questions of drug safety in accordance with the current legal requirements and individual needs.

Our pharmacovigilance services include: 

Graduated Plan Officer / QPPV 

  • Qualified Person for Pharmacovigilance (QPPV) for the European Union
  • national QPPV in EU member states where local representatives are required, in Germany for example as a Graduated Plan Officer according to §63a AMG
  • Efficient safeguarding of legal requirements
     

Function as Information Officer

We check for our clients the compliance with the requirements of the AMG and the HWG and with the marketing authorisation documents for:

  • Labelling
  • Package leaflet (Patient Information Leaflet, PIL)
  • Subject information (summary of product characteristics, SmPC)
  • Advertising (ads, brochures, displays, etc.) and field service documents

 

 

Your Contact

Larissa Gutenmacher-Ruf

Larissa Gutenmacher-Ruf

Pharmacist
Director Pharmacovigilance/EU-QPPV

Midas Pharma GmbH
Rheinstr. 63
55218 Ingelheim
Germany
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