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A team of experts with experience in all aspects of Global Drug Safety and Pharmacovigilance is available to support you with consulting or information services tailored to your particular need.
Drug Safety and Pharmacovigilance
- Qualified Person for PharmacoVigilance (QPPV): The Qualified Person for Pharmacovigilance (QPPV) is an individual personally responsible for a Pharmaceutical company/Marketing Authorization Holders adherence to the legal requirements for drug safety activities. These activities include safety surveillance, reporting, quality system, documentation, training and benefit & risk assessments.
- Pharmacovigilance System Master File: The revised regulations for the European Union now has a requirement for a Marketing Authorization holder to maintain a document with all information relevant for safety of a marketed product. It is the responsibility of the QPPV that the Pharmacovigilance Master File is complete and always up to date.
- Expedited Reporting
- Periodic Reporting
- Benefit/Risk Management
- Pregnancy Surveillance
- Data Privacy Management
- Signal Management
- Procedural documentation
- EManual: In Drug Safety and Pharmacovigilance law’s, guidances, requirements and procedures are constantly changing. Traditional paper based procedural documentation is no longer practical to maintain.
- Medical Review
- Risk Management Plans
- Oberservational Studies
- Post Market Commitments