SERVICES

Pharmacovigilance Services in Turkey

The Turkish Pharmacovigilance Centre (TUFAM) is the national authority responsible for monitoring and evaluating adverse event reports in Turkey. In order to report adverse events, TUFAM has launched the TUFAM Adverse drug reaction reporting form which is available for healthcare professionals (HCPs), the general public, and pharmaceutical companies. As per TUFAM guidelines hospitals having more than 50 beds are obliged to appoint a pharmacovigilance contact person (PCP) who is a physician, pharmacist, or dentist with the main responsibilities of overseeing pharmacovigilance services in turkey, ADR reporting, and providing training to the HCPs. All the HCPS are responsible for providing reports of all serious and suspected ADRs to TUFAM. Other spontaneous reports can be submitted by HCPs either directly to TUFAM or through PCP. In addition to this,a QPPV is employed by the marketing Authorization holders to oversee the pharmacovigilance services on the national level. However, despite having the WHO standard pharmacovigilance system incorporated in Turkey, underreporting and reluctant attitude and unfamiliarity of the public towards ADR reporting are a few of the challenges faced.

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, we provide end-to-end pharmacovigilance services in Turkey 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 Safety Update Report (PSURs)
  • Periodic benefit Risk Assessment report (PBRER)
  • 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 signal management processes
  • 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.

PV 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 Services 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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