Consulting & Support

The planning, implementation and continuous maintenance of a pharmacovigilance system and the associated quality management system is a complex task that requires practical experience and extensive knowledge of the legal requirements and Good Pharmacovigilance Practices (GVP).

In this context, Phavigus can provide you advise and support - among others – with regard to the following tasks and activities:

• Planning, implementation, continuous maintenance and optimization of pharmacovigilance systems and their processes as well as the accompanying quality management systems

• Preparation and continuous maintenance or optimization of the Pharmacovigilance System Master File (PSMF)

• Processing of adverse drug reaction reports from various sources, such as spontaneous reports from physicians, pharmacists or patients (including documentation, assessment and reporting)

• Processing of reports on pharmaceutical-technical complaints from different sources, such as pharmacists or patients (including documentation, evaluation and definition/follow-up of necessary measures)

• Monitoring of authority websites with regard to pharmacovigilance-related topics (including EMA, BfArM, PEI, PRAC, CMDh, CHMP) and definition/follow-up of necessary measures (regulatory intelligence)

• Preparation of subject-specific contracts, such as pharmacovigilance agreements with license partners, agreements for the delimitation of responsibilities, service contracts with pharmacovigilance service providers

• Monitoring of changes in legal requirements in the field of pharmacovigilance, their analysis and the definition/follow-up of necessary measures (e.g. changes in national laws and regulations as well as EU regulations and EU directives, good pharmacovigilance practices)