Scribd Logo
Upload

Welcome to Scribd!

  • Pharmacovigilance Syllabus

    Uploaded by

    Siri Siri
    78 views2 pages
    This document outlines the syllabus for a pharmacovigilance course divided into four modules. Module I introduces pharmacovigilance and covers its history, principles, methodologies and regulations. Module II focuses on adverse drug reaction reporting, including spontaneous reporting systems in various countries and causality assessment. Module III examines adverse drug reactions related to specific organ systems and drug safety in special populations. Module IV addresses signal identification, risk management strategies, and case studies of nonsteroidal anti-inflammatory drugs.

    Original Description:

    Syllabus format

    Original Title

    PHARMACOVIGILANCE SYLLABUS (1)

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    This document outlines the syllabus for a pharmacovigilance course divided into four modules. Module I introduces pharmacovigilance and covers its history, principles, methodologies and regulations. Module II focuses on adverse drug reaction reporting, including spontaneous reporting systems in various countries and causality assessment. Module III examines adverse drug reactions related to specific organ systems and drug safety in special populations. Module IV addresses signal identification, risk management strategies, and case studies of nonsteroidal anti-inflammatory drugs.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    78 views2 pages

    Pharmacovigilance Syllabus

    Uploaded by

    Siri Siri
    This document outlines the syllabus for a pharmacovigilance course divided into four modules. Module I introduces pharmacovigilance and covers its history, principles, methodologies and regulations. Module II focuses on adverse drug reaction reporting, including spontaneous reporting systems in various countries and causality assessment. Module III examines adverse drug reactions related to specific organ systems and drug safety in special populations. Module IV addresses signal identification, risk management strategies, and case studies of nonsteroidal anti-inflammatory drugs.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 2

    PHARMACOVIGILANCE SYLLABUS

    MODULE I

     INTRODUCTION
     HISTORICAL REVIEWS
     BASIC PRINCIPLES OF PV
     METHODOLOGIES FOR PV
     MODULE II (REGULATIONS IN PV IN CLINICAL RESEARCH)
     PV RELATED TOPICS AT THE LEVEL OF ICH
     MEDICAL DICTIONARY FOR REGULATORY ACTIVITY
     GVP MODULE IV V FDA & EU
     PDA OF EV

    MODULE II ADR REPORTING

     SPONTANEOUS REPORTING
     MECHANISMS OF ADVERSE DRUG REACTIONS
     SPONTANEOUS REPORTING – UK/FRANCE/US
     DATA PROCESSING
     CAUSALITY ASSESSMENT

    MODULE III PHARMACOVIGILANCE AND SELECTED SYSTEM


    ORGAN CLASSES

     HAEMATOLOGICAL ADRS
     HEPATIC ADRS
     RENAL ADVERSE DRUG REACTIONS
     DRUG SAFETY IN PREGNANCY
     PV IN REDIRECTING
     DISEASE PREVALENCE AND DRUG USE IN THE ELDERLY
     FATAL MEDICATION ERRORS

    MODULE IV

     SIGNAL IDENTIFICATION
     RISK MANAGEMENT STRATEGIES EUROPEAN
     NSAIDS-COX-2 INHIBITORS-RISKS AND BENEFITS
    EDUCATIO
    N
    For Further Information Contact
    Thanks & Regards,
    Javid Hussain
    8143190671

    Suite 503, 5th Floor,HMDAMythrivanam, Ameerpet, Hyderabad- 500038, Andhra Pradesh. INDIA
    Phone:040-40157023 Email:info@ikyaglobaled u.net Website: http://ikyaglobaledu.net

    You might also like