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 (German Medicines Act) and the HWG (German Drug Advertising Act) 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 Expert for Pharmacovigilance
Larissa Gutenmacher-Ruf
Pharmacist
Director Pharmacovigilance/EU-QPPV
Midas Pharma GmbH
Rheinstr. 63
55218 Ingelheim
Germany
Rheinstr. 63
55218 Ingelheim
Germany