DDReg Pharma

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 activities, 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 activities 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
Risk Management Plan
Aggregate Reports
Signal Management
QPPV Services
PV Audit & Compliance
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