Preview to Lessons on Learners' Request - PV Bundle 1

The Scope of Pharmacovigilance

  • Introduction to Pharmacovigilance
  • Need of Pharmacovigilance
  • Issues (related to medicinal product) covered under PV
  • Products covered under PV
  • Application of PV in pre-market and post-market stage

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Pharmacovigilance (PV) Methods 

  • Factors that influence the selection of the PV method
  • A brief discussion on various PV methods:
  • Passive surveillance - examples:
  • Spontaneous reports
  • Case series
  • Stimulated reporting
  • Active surveillance - examples:
  • Sentinel surveillance
  • Registries
  • Comparative observational studies
  • Targeted clinical investigations
  • Descriptive studies

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21 CFR Part 11

  • Introduction to CFR
  • Organization of CFR
  • Brief discussion on Subparts of 21 CFR Part 11:
  •                          Subpart A -General Provisions
                             Subpart B -Electronic Records
                             Subpart C -Electronic Signatures
  • Role of 21 CFR Part 11


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AESI (Adverse Event of Special Interest)

  • AESI explained with an example
  • Sources of AESI
  • Handling of AESI with example
  • Significance of studying AESI




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Adverse Events Following Immunization (AEFI)  

  • Introduction to Adverse Events Following Immunization 
  • Definition of AEFI
  • Sources of AEFI
  • Categorization of AEFI explained with examples:
  • Vaccine product related reaction
  • Vaccine quality-defect related reaction
  • Immunization error-related reaction
  • Immunization anxiety-related reaction
  • Coincidental event
  • Vaccine reactions categories - explained

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Materiovigilance Programme of India (MvPI)

  • Introduction to MvPI 
  • Definition of Materiovigilance 
  • Objectives of MvPI 
  • Importance of MvPI 
  • Indian Requirements of Reporting of Medical Device adverse events (MDAEs) under MvPI


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Content of Periodic Safety Update Report (PSUR)

  • Title Page
  • Executive Summary
  • Table of Contents
  • Introduction
  • Worldwide marketing authorization status
  • Actions taken in the reporting interval for safety reasons
  • Changes to reference safety information
  • Estimated exposure and Use Patterns
  • Data in summary tabulations
  • Summaries of significant findings from clinical trials during the reporting interval
  • Findings from non-interventional studies
  • Information from other clinical trials and Sources
  • Non-clinical data
  • Literature
  • Other periodic reports
  • Lack of efficacy in controlled clinical trials
  • Late-breaking information
  • Overview of signals: new, ongoing, or closed
  • Signal and risk evaluation
  • Benefit evaluation
  • Integrated benefit-risk analysis for authorized indications
  • Conclusions and actions
  • Appendices to the PSUR

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Electronic Common Technical Document (eCTD)   

  • Introduction to Electronic Common Technical Document (eCTD )
  • Introduction to CTD
  • Importance of eCTD
  • Use of eCTD
  • Structure of eCTD
  • Benefits of eCTD

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ICSR Nullification

  • Introduction to ICSR Nullification
  • Examples of ICSR Nullification
  • Scenarios that initiate nullification of ICSR
  • Scenarios that do not initiate nullification of ICSR
  • Principles for nullification of ICSR


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Investigational New Drug Application (INDA) 

  • Introduction to INDA
  • When to submit INDA?
  • Purpose of INDA
  • Types of INDA
  • Categories of INDA
  • Contents of INDA
  • INDA Process

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Medical Device Reporting - US 

  • Definition of medical device
  • Introduction to medical device reporting in US
  • Brief discussion on medical device reports
  • Brief discussion on reporters
  • Discussion on requirements of medical device reporting:
  • Mandatory reporting
  • Voluntary reporting

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Klinibytes Lessons in Clinical Research - Annual Membership  




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New Drug Application (NDA) 

  • Introduction to NDA
  • Importance/Need of NDA
  • When to Submit NDA
  • Data included in NDA
  • NDA Process

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Pharmacovigilance Program of India (PvPI) 

  • Introduction to PvPI
  • Objectives of PvPI
  • Brief discussion on National Coordinating Centre (NCC)
  • Brief discussion on ADR Monitoring Centre (AMC)
  • Overview of management of ADR reports under PvPI
  • Importance of PvPI

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Qualified Person for PV (QPPV) 

  • QPPV - Introduction
  • Need of QPPV
  • Responsibilities of QPPV
  • Requirements to become QPPV
  • Qualities of QPPV
  • LRP-PV {or Local QPPV or National Person Responsible for PV (NPRP)}

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Safety Data Exchange Agreement (SDEA) 

  • Introduction to Safety Data Exchange Agreement (SDEA)
  • Need of SDEA
  • Importance of SDEA
  • Preparation of SDEA
  • Points to be included in SDEA

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Safety Monitoring during Clinical Trial 

  • Introduction of Safety in Clinical Trial
  • Roles of Stakeholders in safety monitoring during clinical trial:
  • Sponsor
  • Investigator
  • Research subjects
  • Institutional Review Board/Ethics Committee
  • Regulatory Authority
  • Data and Safety Monitoring Board (DSMB)
  • Communicating safety information among stakeholders
  • Purpose of safety monitoring in clinical trial
  • CIOMS recommendations for safety monitoring during clinical trial

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Signal Detection 

  • Signals in Pharmacovigilance
  • Introduction to Signal detection 
  • Sources of Signals
  • Methods of Signal detection
  • Importance of Signal detection
  • Signal Management Process -Definition

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Adverse Event (AE) Vs Adverse Drug Reaction (ADR) 

  • Effect of medicinal product on the human body with example
  • Introduction to Adverse Event (AE) 
  • Example of AE
  • Introduction to Adverse Drug Reaction (ADR) 
  • Example of ADR

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Side Effect Vs Adverse Effect 

  • Introduction to Side effect
  • Example of Side effect
  • Introduction to Adverse effect
  • Example of Adverse effect
  • Differences between Side effect and Adverse effect

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Case Narrative or Patient Narrative 

  • Introduction to Case/Patient narrative
  • Importance of Case/Patient narratives
  • Objective of narrative writing
  • Various sources of information for narratives 
  • Process of Case/Patient narrative writing 
  • Generalized template of Case/Patient narrative
  • Example of Case/Patient narrative (Based on mentioned template)
  • Qualities of a well-defined narrative

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CIOMS Form 

  • Introduction to CIOMS
  • Aim of CIOMS
  • List of few works done by CIOMS
  • CIOMS form -Introduction
  • Required elements for a valid CIOMS form
  • Importance of CIOMS form

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ICSR (Individual Case Safety Report) 

  • Introduction to ICSR
  • Generation of ICSR
  • Sources of ICSR
  • Voluntary forms and Mandatory forms
  • Minimum Criteria for a valid ICSR
  • ICSR processing

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VigiFlow

  • Introduction to VigiFlow
  • Need of VigiFlow
  • Development of VigiFlow
  • Organization of VigiFlow
  • How is Vigiflow used
  • Importance of VigiFlow

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MedWatch Forms 

  • Introduction to MedWatch Program
  • Key functions of MedWatch Program
  • Importance of MedWatch Program
  • Brief discussion on different types of MedWatch Forms:
  •            MedWatch form 3500 A
               MedWatch form 3500 
               MedWatch form 3500 B

  • FDA MedWatch learn

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Severe Adverse Event Vs. Serious Adverse Event 

  • Introduction to Severe Adverse Event
    • Mild Adverse Event
    • Moderate Adverse Event
    • Severe Adverse Event
  • Severe Adverse Event - Example
  • Introduction to Serious Adverse Event
  • Serious Adverse Event - Example
  • Difference between Severe Adverse Event and  Serious Adverse Event

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Argus Safety System

  • Introduction to Argus Safety System
  • Objective of Argus Safety System
  • Oracle Argus System-Introduction
  • Features of Oracle Argus System:
    • Flexible drug safety database
    • Multi-tenancy feature
    • Supports all standard dictionaries
    • Maintains regulatory compliance 
    • Integrated safety and risk management
    • Improves reconciliation process 
    • Data exchange through Argus System in accordance with ICH guidelines (ICH:E2B)
    • Multidimensional data analysis with Argus system
  • Generalized process overview of Argus System

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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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