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Pharmacovigilance Services in Kazakhstan

It is vital for all pharmaceutical companies involved in medicinal products and medical devices for having a pharmacovigilance program for a continuum to safety monitoring of these products. To achieve this, role of marketing Authorization Holders (MAHs), physicians, and patients/consumers to report adverse drug reactions (ADR) reports is significant. In the Republic of Kazakhstan, The National Center for Expert Evaluation of Medicinal Products, Medical Devices and Medical Equipment of the Ministry of Health and Social Development is the authority responsible for pharmacovigilance. In order to attain a comprehensive response, it is mandatory in Kazakhstan for market authorization holders (MAH), healthcare professionals, and pharmaceutical professionals to report information regarding ADRs including suspected ADRs. Moreover, understanding the complex local pharmacovigilance system is crucial, therefore a local pharmacovigilance responsible person plays an important role in this. To achieve this, Kazakhstan expects MAH to appoint the local QPPV residing in the country to oversee and coordinate the pharmacovigilance services.

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio for Kazakhstan, we provide end to end Pharmacovigilance Services in Kazakhstan that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.

DDReg pharmacovigilance Services portfolio include:

ICSR Processing and Submission

  • Triage of initial and follow-up ICSRs, SUSARs,
  • Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers

Risk Management Plan

  • Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
  • Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information and prepare reports that recommend risk management methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL)

Aggregate Reports

  • Periodic Benefit-Risk Evaluation Report (PBRERs)
  • Periodic Safety Update Report (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Signal Management

  • Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, pharmacovigilance aggregate reporting as well as regulatory agency website monitoring.
  • Utilizes a variety of in-house tools and databases for signal detection and tracking safety signal monitoring
  • Reviews safety signals for ICSRs, aggregate reports and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
  • Performs label update analysis
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.s

QPPV Services

  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc.
  • Review & sign off of Aggregate reports, Signal Reports and RMPs
  • Retainer services for QPPV and Deputy
  • Monthly reconciliation
  • Medical review of Signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics
  • PV Quality Management System Oversight

PV Audit & Compliance

  • Review compliance audit to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Conduct regular gap assessments of PV staff at site location
  • Provide organizational training on safety audits and inspections
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