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Pharmacovigilance Training

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Pharmacovigilance Training

Course Details

This course is an integrated course that will provide you with a complete understanding of the of the clinical research process, pharmacovigilance and drug safety methodologies to enhance skills and knowledge to the level expected of a Clinical Research and Pharmacovigilance Professional.

Who can learn?

Candidates are preferred from:

  • Life sciences (M.Pharm., B.Pharm., M.Sc.)
  • MBBS, BDS, BHMS, and BAMS

Courses Outline:

  • Pharmacovigilance
    • Introduction
    • Historical Overview
    • Basic principles of Pharmacovigilance in Clinical Trials
    • Methodologies for Pharmacovigilance
  • Pharmacovigilance Regulations in Clinical Research
    • FDA and EU perspectives
    • Drug regulatory activities MedDRA
    • Regulatory aspects in Pharmacovigilance
    • Eudra Vigilance
    • Pharmacovigilance Regulations in clinical research
  • Adverse Drug Reactions and Safety Reporting with ORACLE AERS and ARGUS
    • ADR Reporting – an introduction
    • Causality Assessment of suspected Adverse Drug Reactions
    • Periodic Safety Update Reports (PSUR) for Marketed Drugs (ICH E2C)
    • Expedited Reporting Requirements
    • Individual case safety reports
    • Electronic safety update reports
    • WHO & safety monitoring
  • Case Processing and Narrative writing
    • Data Entry
    • MedDRA/ WHO-DRL/DD Coding of reported primary diagnosis & Concomitant medications
    • Case Narrative Writing
    • Query generation and forwarding of queries
    • Quality control- an overview
    • Active Case / Query follow up – an overview
  • Compliance to Clinical Safety and Pharmacovigilance Regulations
    • Review of benefits-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
    • Internal audit of Pharmacovigilance activities of a company
    • Key functionalities of the Adverse Event Systems
  • Pharmacovigilance Management and Importance
    • Pharmacovigilance Databases
    • Setting up a Pharmacovigilance center in industry
    • Management of Pharmacovigilance Data
    • Risk management in Pharmacovigilance
    • Data Management & Software solutions
    • Effective communication inPharmacovigilance
    • Pharmacovigilance in special situations
    • Pharmacovigilance capacity building
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