Medical Monitoring

Our Data Safety Monitoring Board (DSMB) strives to provide you with improved workflows, compliance, and communication to ensure the safety and integrity of your clinical study data. We also provide safety data review by a physician with experience in pharmacovigilance including assessment of the data and its significance to the conduct of the study. We then provide recommended actions to be taken for e.g., changes to the Investigator Brochure, Informed Consent Form, or study protocol.

Qualified Person for Pharmacovigilance (QPPV) and Local Person for Pharmacovigilance (LPPV)

Marketing Authorization Holder (MAH) in Europe are required to establish a robust PV system for their products. The PV system in Europe should have a Qualified Person for Pharmacovigilance (QPPV) for creation and oversight of this system and has legislative responsibilities for this role. Countries in Europe also legally require a local person for Pharmacovigilance (LPPV) at a country level who may report to the EU QPPV.

MIVIGILANCE helps you identify requirements for EU QPPVs and LPPVs, to ensure you have the right resources in place to fully comply with the regulations for your PV system in Europe.