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PHARMACOVIGILANCE

Monitoring Medicines. Protecting Patients. Building Trust.

At Evolet, patient safety extends beyond product manufacturing. Our Pharmacovigilance System provides continuous safety surveillance throughout the lifecycle of every medicinal product – from development and regulatory approval to post-marketing use.

Built in alignment with the European Union Good Pharmacovigilance Practices (EU-GVP), our system complies with the global Pharmacovigilance standards and has been successfully inspected and certified by the competent health authority of the Republic of Kazakhstan.

Comprehensive Pharmacovigilance Frameworks

Our Pharmacovigilance System supports product safety through:

      • Pharmacovigilance System Master File (PSMF) management
      • Periodic Safety Update Reports (PSUR) management
      • Risk Management Plan (RMP) development and maintenance
      • Adverse Event and Individual Case Safety Report (ICSR) management
      • Global and Local Qualified Person Responsible for Pharmacovigilance (QPPV) oversight
      • Medical Information services (multilingual), including handling of medical enquiries and product quality complaints
      • Continuous global and local medical literature surveillance
      • Signal detection and benefit-risk evaluation
      • Regulatory safety reporting and compliance across international markets
      • Dedicated safety reporting channels through telephone, email, digital platforms, and business partners

Adverse Drug Reaction (ADR) [form to fill, add dropdown list if its patient or doctor]

Add confidential clause

Refer the form from:

https://www.blissgvs.com/ade-or-adr-form

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