Preview to Lessons in PV - Concept Capsule Bundle

The Concept of Pharmacovigilance

  • Concept of Pharmacovigilance
  • Need of Pharmacovigilance
  • Scope of Pharmacovigilance
  • The importance of Pharmacovigilance - explained with an example

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Adverse Drug Reaction (ADR) 

  • Concept of Adverse Drug Reaction (ADR)
  • Definition of ADR
  • Difference between ADR and Side Effects
  • Difference between Adverse Event (AE) and ADR
  • Example of ADR

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Adverse Event (AE)

  • Concept of Adverse Event (AE)
  • Definition of AE
  • Example of AE


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Conditions to consider an event/reaction "Unexpected"

  • Understanding of the different conditions in which an adverse event or reaction is considered "unexpected"





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Effect of Medicinal Product  

  • Medicinal Product - Introduction
  • Effects of Medicinal Product - Explained with examples






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Expected/Labeled/Listed & Unexpected/Unlabled/Unlisted Event or Reaction

  • A clear understanding of the important terms: Expectedness/Listedness/Labeledness of Adverse Event/Reaction / Unexpectedness/Unlistedness/Unlabeledness of Adverse
  • Terms used in pre-market stage and post-market stage for an AE/ADR in the drug lifecycle
  • Factors that decide the usage of these terms


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Serious Adverse Event (SAE) & Serious Adverse Reaction (SAR)

  • Concept of Serious Adverse Event & Serious
  • Adverse Reaction (SAE/SAR)
  • Definition of SAE/SAR
  • Outcome of SAE/SAR
  • Non-Serious Adverse Event & Non-Serious Adverse Reaction (NSAE/NSAR)

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Suspected Unexpected Serious Adverse Reaction (SUSAR)   

  • Concept of SUSAR (Suspected Unexpected Serious Adverse Reaction)
  • Definition of SUSAR
  • Breakdown of terms of SUSAR
  • Assessment of SUSAR
  • Reporting time-frame of SUSAR

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Importance of Reporting - AE/AR

  • Importance of reporting of adverse effects associated with medicinal products
  • Examples demonstrating impact of reporting and not reporting of adverse events related to a medicinal product


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Criteria for Assessing Expectedness 

  • Understanding of different criteria on the basis of which expectedness/listedness/labeledness of an adverse event/reaction is determined

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Causality Assessment

  • Introduction to Causality Assessment
  • Need of Causality Assessment in PV
  • Aim of causality assessment
  • How to do Causality assessment
  • Importance of Causality assessment

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Methods of Causality Assessment

Methods of Causality Assessment:

  •   Clinical judgment or global introspection
  •   Algorithms
  •   Probabilistic methods


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WHO Scale 

  • Introduction to WHO-UMC system
  • Basic criteria that comprise WHO-UMC system
  • Brief discussion on Categories of WHO-UMC system
                    Certain
                    Probable
                    Possible 
                    Unlikely
                    Unclassified/Conditional
                    Unassessable/Unclassifiable

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Naranjo Algorithm

  • Introduction to Naranjo Algorithm
  • Need/Importance of Naranjo Algorithm
  • Brief discussion on (10) Questions enclosed in Naranjo Algorithm

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Types of Adverse Drug Reactions (ADR)


  • Introduction of ADRs
  • Different types of ADRs discussed with examples:
    • Type-A (Augmented) reaction
    • Type-B (Bizarre) reaction
    • Type-C (Continuous drug use) reaction
    • Type-D (Delayed) reaction
    • Type-E (End of use) reaction
    • Type-F (Failure of therapy) reaction

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MedDRA Part 1  

  • MedDRA - Introduction
  • Need of MedDRA
  • Objective of MedDRA
  • MedDRA -Multilingual dictionary
  • Where is MedDRA used?
  • Scope of MedDRA
  • MSSO
  • JMO
  • Naming convention of MedDRA
  • Benefits of MedDRA  

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Naranjo Algorithm

  • Introduction to Naranjo Algorithm
  • Need/Importance of Naranjo Algorithm
  • Brief discussion on (10) Questions enclosed in Naranjo Algorithm

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Types of Adverse Drug Reactions (ADR)


  • Introduction of ADRs
  • Different types of ADRs discussed with examples:
    • Type-A (Augmented) reaction
    • Type-B (Bizarre) reaction
    • Type-C (Continuous drug use) reaction
    • Type-D (Delayed) reaction
    • Type-E (End of use) reaction
    • Type-F (Failure of therapy) reaction

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Testimonials

Comments from the students/learners who have benefitted from our learning content

your videos helped me to get a job as a case handler two years ago! Now, I love the field and am being trained as a Domain specialist for IT teams! thank you!


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Mam, it was really difficult to understand by own but your video makes very easy to understand and remembering about GVP and other topic that are you discussed. Thankyou so much mam for making videos and request for making more ... Its truly appreciable efforts from your side.

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OMG this is one of the best videos i have seen on trial overview. I am not a medical or research person but working for a pharmaceutical company and wanted an overview. You explained it very well. Thanks a bunch


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