DDReg Pharma

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 activities.
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 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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