Pharmacovigilance agreements and audits

Pharmacovigilance agreements (PVA)

It should be assuranced that safety information is exchanged effectively in every stages of product delivery chain form manufactures to consumer. Marketing authorization holder shall clarify the responsibilities regarding safety responsibilities with different stakeholders (e.g manufacturers, distibutors, partners) ensuring that the European Qualified Person for Pharmacovigilance will be updated with all safety issues and emerging safety concerns in real time.

Medfiles can support in the creation of safety data exchange agreements with business partners (e.g. associated manufacturers, marketing partners, distribution networks or vendors) that establish clear responsibilities, communication channels and methods for the exchange of safety information.

PV audits

Pharmacovigilance (PV) Audits are designed to verify the appropriateness and effectiveness of the implementation and operation of a PV system, including its quality system. Medfiles has dedicated and knowledgeable auditors to conduct audits that meet all of your PV system and data needs.

Medfiles audits cover the whole PV system (case intake, adverse events processing and submission, project management, data management, QPPV role and responsibilities, aggregate report writing, signal and risk management, clinical safety, etc.). The audits can include e.g audits of your affiliates, license partners, service providers, and distributors, as well as due intelligence audits.

Medfiles can assist you to implement a risk-based approach to PV audits and create an appropriate audit strategy, effective audit program, and robust CAPA management system in line with GVP Module IV.

For more information please contact

  • Pharmacovigilance Services

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