Our Pharmacovigilance services are ISO 9001-2015 certified
Authorized Person for Pharmacovigilance EAEU
Appointment of an Authorized Person for Pharmacovigilance with the required qualifications to perform all delegated functions in the Territory EAEU.
*Authorized person for pharmacovigilance(APPV = QPPV) shall mean a qualified person responsible for the implementation of pharmacovigilance, and appointed by the Marketing Authorization Holder, or by the manufacturer of medicinal products. The Authorized person for pharmacovigilance shall be at the marketing authorisation holder’s disposal permanently and continuously (24/7) according Russian Federal law. The APPV shall reside and operate in the territory of the EEU.
Generation of Pharmacovigilance System
Development of Pharmacovigilance System Master-file (PSMF) including based on the appropriate detailed description of Pharmacovigilance System (DDPS).
Development of SOPS in accordance with the requirements of contracting parties or Regulatory Authorities (collection and processing of spontaneous reports, reporting to Regiulatory Authorities, PSUR, risk management plan…).
Development, creation and validation of pharmacovigilance database (in case a company lacks it).
Development of Safety Data Exchange Agreements (SDEAs) with contracting parties.
Development of audit plan and pharmacovigilance inspection plan for contracting party and your company.
Development of pharmacovigilance training plan and training multimedia classes.
Conducting monitoring of web-sources and literature, search for information on drug safety and efficiency.
Development of Risk Management Plans (RMPs) for Marketing Authorization.
Development of Periodic Safety Update Reports (PBRERs/PSURs) and ACOs.
Preparation of Development Safety Update Reports (DSURs).
Establishment, processing and subsequent signal management.
Development of Company Core Safety Information (CCSI) for Marketing Authorization.
Pharmacovigilance System quality management.
Monitoring of compliance of Pharmacovigilance System with the requirements of current legislation.
Organization of the process for collecting, processing, coding of spontaneous consumer reports, inclusion of information in the pharmacovigilance database (case processing).
Organization of the process for urgent AE notification (subject to urgent reporting).
Literature screening (regular monitoring), preparation of literature reviews of drug safety.
Preparation of PSURs • Management of drug safety signals.
Provision of services of the Qualified Person for Pharmacovigilance (QPPV)
We offer professional services for pharmacovigilance outsourcing to subjects of circulation of medicinal products
+7 800 3507051
QPPV & a representative of QPPV & contact person for PV