Main Services At PVigi, we specialize in delivering top-tier pharmacovigilance services across Turkey, Europe, the Middle East, and Africa. Our expertise ensures compliance with global regulations while maintaining the highest standards of safety
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PVigi – Your Trusted Pharmacovigilance Consulting Partner in Turkey, Europe, the Middle East, and Africa At PVigi, we provide expert pharmacovigilance (PV) consulting services across Turkey, Europe, the Middle East, and Africa (EMEA).
Contract Research Organisation In addition to its pharmacovigilance services, PVigi also offers a range of contract research organisation (CRO) services to support the clinical development of pharmaceutical products. These services include:Clinical Trial Management:
At PVigi, our Pharmacovigilance Services are designed to ensure the safety and efficacy of pharmaceutical products. Leveraging our expertise and in-depth understanding of regional regulations, we offer comprehensive pharmacovigilance solutions. From adverse event
Published Date: April 15, 2014 CHAPTER ONEPurpose, Scope, Basis and DefinitionsARTICLE 1 – (Amended:OG-21/7/2022-31899)(1) The purpose of this Regulation is to determine the procedures and principles regarding thesystematic monitoring of adverse reactions and
Published Date: 15.07.2014 Table of Contents Chapter I. 2 Introduction. 2 1.1 Introduction. 2 Chapter II. 2 Structures and Processes. 2 2.1 Principles for assigning additional monitoring status to a medicinal product 2
APPENDIX I – Definitions Published Date: 12.06.2014Table of Contents EU Reference date, Union reference date. 3 Adverse event (AE), Adverse experience. 3 Adverse reaction, Adverse drug reaction (ADR), Suspected adverse (drug) reaction, Adverse
Publish Date: 12.06.2014 İçindekilerAB Referans tarihi, Birlik referans tarihi ................................................................................... 3Advers olay (AO), Advers deneyim........................................................................................... 3Advers reaksiyon, Advers ilaç reaksiyonu (AİR), Şüpheli advers (ilaç) reaksiyon, Advers etki,İstenmeyen etki .......................................................................................................................... 3Asgari raporlanabilirlik kriterleri ...............................................................................................
Publish Date: 12.06.2014 İyi FarmakovijilansUygulamaları (İFU)KılavuzuModül I – Advers ilaçreaksiyonlarının yönetimi vebildirimiTÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU12.06.20141İçindekilerBÖLÜM IAmaç, Kapsam ve Tanımlar1.1. Amaç ……………………………………………………………………………………... 41.2. Kapsam …………………………………………………………………………………... 41.3.Tanımlar ………………………………………………………………………………….. 41.3.1. Advers reaksiyon ………………………………………………………………... 41.3.2.
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
