Published Date: 12.06.2014 Table of Contents Chapter I Purpose, Scope and Definitions 1.1 Purpose 4 1.2 Scope 4 1.3 Definitions. 4 1.3.1 Adverse reaction. 4 1.3.2 Individual case safety report (ICSR) 4 1.3.3
Published Date: 15 Nisan 2014 BİRİNCİ BÖLÜMAmaç, Kapsam, Dayanak ve TanımlarAmaçMADDE 1 – (1) Bu Yönetmeliğin amacı, ilaçların güvenli bir şekilde kullanımlarınınsağlanması amacıyla adversreaksiyonların ve yarar/risk dengelerinin sistematik bir şekilde izlenmesi, bu hususta
You can check some of current pharmacovigilance regulations here: Legislation Guideline
Pvigi: Local and Regional Expert in Pharmacovigilance At Pvigi, we are dedicated to redefining excellence in pharmacovigilance and regulatory solutions across Turkey, the Middle East, and Africa. With a commitment to innovation, precision,
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Guideline on Good Pharmacovigilance Practices (GVP) Module III- Periodic benefit-risk evaluation report (PBRER)
Introduction Pvigi is a reputable pharmacovigilance service provider and contract research organisation (CRO) operating in Turkey, Middle East, and Africa. With a proven track record of excellence, Pvigi offers comprehensive pharmacovigilance solutions to
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