pharmacovigilance training in hyderabad

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COVALENT:-Covalent is a group of company which has services and operations in Clinical, Information Technology, Energy, ...

  • Category: Other Services
  • Published: 02/04/2015
  • Current Rating: /5 0 Vote

    Description

    COVALENT:-
    Covalent is a group of company which has services and operations in Clinical, Information Technology, Energy, consumer products, Power and Infrastructure.


    Training @ Covalent:-
    We arededicated to establish ourselves as ''A values-driven organization''. These values will continue to direct our growth and organization’s operation. “Covalent” values supporting the way like “Kreative”.


    Pharmacovigilance Training / Course/ Training Institute:-


    Module I Pharmacovigilance


    Introduction
    Historical Overview
    Basic principles of Pharmacovigilance in Clinical Trials
    Methodologies for Pharmacovigilance


    Module II Regulations in Pharmacovigilance in Clinical Research


    FDA and EU perspectives
    Drug Regulatory Activities MedDRA
    Regulatory Aspects in Pharmacovigilance
    EudraVigilance
    Regulations in Pharmacovigilance in Clinical Research


    Module III Adverse Drug Reactions and Safety Reports


    ADR Reporting
    Causality Assessment of Suspected Adverse Drugs Reactions
    Periodic Safety Update Reports (PSURs) For Marketed Drugs (ICH E2C)
    Expedited Reporting Requirements
    Individual case safety reports
    Periodic safety update reports
    Electronic safety reporting
    WHO & safety monitoring


    Module IV Signal Analysis


    Definition of signal and type of signal
    Conducting signal detection in clinical and post marketing surveillance
    Defining signal in relation to risk/benefit
    Signal generation to decision making
    Signal Detection Tools
    Understanding signals & benefit risk determinations


    Module V Compliance to Clinical Safety and Pharmacovigilance Regulations


    Review of benefit-risk assessments and management
    Scope of Pharmacovigilance inspection and conduct of inspection
    Internal audit of pharmacovigilance activities of a company
    Pharmacovigilance inspection reports
    Pharmacovigilance compliance and inspection
    Quality System in Pharmacovigilance : Good Practices, SOPs, Preparation for Audits & Inspections
    Scope of Pharmacovigilance inspection and conduct of inspection
    Internal audit of pharmacovigilance activities of a company
    Key Functionalities of the Adverse Event Systems
    Quality System in Pharmacovigilance : Good Practices, SOPs, Preparation for Audits & Inspections


    Module VI Pharmacovigilance Management and Importance


    Pharmacovigilance Database
    Setting up a Pharmacovigilance Centre in Industry
    Management of Pharmacovigilance Data
    Risk Management in Pharmacovigilance
    Data management & software solutions
    Effective communication in pharmacovigilance
    Pharmacovigilance in special situations
    Pharmacovigilance capacity building



    Training Duration (Classroom/Online): 3-Months/2-Months
    Training Fee: 20K/25k
    Mobile: 9848733309


    Website:http://covalentech.com/pharma_covigilnnce.html


    Phone Number : 9848733309

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