TOPIC BUNDLE NAME Mode KEY LEARNING POINTS
Concept of Pharmacovigilance
PV - Concept Capsules Video Lesson
  • Concept of Pharmacovigilance
  • Need of Pharmacovigilance
  • Scope of Pharmacovigilance
  • The importance of Pharmacovigilance is explained with an example
Adverse Drug Reaction (ADR) 

PV - Concept Capsules
Video Lesson
  • Concept of Adverse Drug Reaction (ADR)
  • Definition of ADR
  • Difference between ADR and Side Effects
  • Difference between Adverse Event (AE) and ADR1
  • Example of ADR
Adverse Event (AE) 

PV - Concept Capsules
Video Lesson
  • Concept of Adverse Event (AE)
  • Definition of AE
  • Example of AE
Conditions to consider an event/reaction "Unexpected"

PV - Concept Capsules
Video Lesson
  • Understanding of the different conditions in which an adverse event or reaction is considered "unexpected"
Effect of Medicinal Product 

PV - Concept Capsules
Video Lesson
  • Medicinal Product - Introduction
  • Effects of Medicinal Product - Explained with example listed below
                      (a) The desired (therapeutic) Effect of Medicinal Product
                      (b) Undesired Effect of Medicinal Product

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

PV - Concept Capsules
Video Lesson
  • A clear understanding of the important terms
                  (a) Expectedness/Listedness/Labeledness of Adverse Event/Reaction
                   (b) Unexpectedness/Unlistedness/Unlabeledness of Adverse Event/Reaction
  • Terms used in pre-market stage and post-market stage for an AE/ADR in the drug lifecycle
  • Factors that decide the usage of terms Expectedness/Listedness/Labeledness and  Unexpectedness/Unlistedness/Unlabeledness of Adverse Event/Reaction

                      (a) Type of medicinal product
                      (b) Type of reference safety information document

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

PV - Concept Capsules
Video Lesson
  • 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)
Suspected Unexpected Serious Adverse Reaction (SUSAR) 

PV - Concept Capsules
Video Lesson
  • Concept of SUSAR (Suspected Unexpected Serious Adverse Reaction)
  • Definition of SUSAR
  • Breakdown of terms of SUSAR
  • Assessment of SUSAR
  • Reporting time-frame of SUSAR
Importance of Reporting - AE/AR

PV - Concept Capsules
Video Lesson
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
Criteria for Assessing Expectedness 

PV - Concept Capsules
Video Lesson
  • Understanding of different criteria on the basis of which expectedness/listedness/labeledness of an adverse event/reaction is determined
21 CFR Part 11
Learners' Request - PV Video Lesson
  • 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
AESI (Adverse Event of Special Interest)
Learners' Request - PV
Video Lesson
  • AESI explained with an example
  • Sources of AESI
  • Handling of AESI with example
  • Significance of studying AESI
Adverse Events Following Immunization (AEFI)
Learners' Request - PV
Video Lesson
  • 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
Biomedical Research
Learners' Request - CR
Video Lesson
  • Introduction to Biomedical research
  • Objective of Biomedical research
  • Importance/Contribution of Biomedical Research in Healthcare System
  • Brief discussion on elements of Biomedical Research:
                           Basic Research
                           Pre-Clinical Research
                           Clinical Research
                           Translational Research

Clinical Data Interchange Standards Consortium (CDISC)

Learners' Request - CDM
Video Lesson
  • Introduction to CDISC
  • Need of CDISC
  • Origin of CDISC
  • Importance of CDISC
  • How does CDISC work
  • CDISC Standards:
  • Foundational or data content standards
  • Standard for Exchange of Nonclinical Data(SEND)
  • Protocol Representation Model (PRM)
  • Clinical Data Acquisition Standards Harmonization (CDASH)
  • Study Data Tabulation Model (SDTM)
  • Analysis Data Model (ADaM)
  • Data exchange standards
  • Therapeutic areas
Central Laboratory
Learners' Request - CR
Video Lesson
  • Introduction to Central laboratory
  • Need of Central laboratory
  • Importance of Central laboratory
  • How does Central laboratory work
  • Benefits of Central laboratory
Clinical Trial Lifecycle

Learners' Request - CR
Video Lesson
  • Introduction to Clinical Trial
  • Basic overview of the Clinical Trial Process
  • Stages of Clinical Trial explained:
                      Trial/Study Initiation
                      Trial/Study conduct
                      Trial/Study close-out
CRC Vs CRA

Learners' Request - CR
Video Lesson
  • Introduction to CRC
  • Introduction to CRA
  • CRC functions, roles and responsibilities
  • CRA functions, roles and responsibilities
  • Comparative study of CRC and CRA
Materiovigilance Programme of India (MvPI)

Learners' Request - PV
Video Lesson
  • Introduction to MvPI 
  • Definition of Materiovigilance 
  • Objectives of MvPI 
  • Importance of MvPI 
  • Indian Requirements of Reporting of Medical Device adverse events (MDAEs) under MvPI: 
                 What to report? 
                 Who can report? 
                 How to report? 
                 Whom to report? 
                 Process of assessment of adverse event reports in MvPI 
                 Reporting timelines
Drug Regulatory Authority of India

Learners' Request - CR
Video Lesson
  • Introduction to Drug Regulatory Authority
  • Objectives of Drug Regulatory Authority
  • Responsibilities of Drug Regulatory Authority
  • Structure and function of National Drug Regulatory Authority (CDSCO)
  • Structure and function of State Drug Regulatory Authorities
  • Other statutory bodies and advisory committee (who helps Drug Regulatory Authorities in functioning)
Pharmacovigilance (PV) Methods

Learners' Request - PV
Video Lesson
  • 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
World Health Organization (WHO)

Learners' Request - CR
Video Lesson
  • Introduction to WHO 
  • Objectives of WHO
  • Core functions of WHO
  • Main bodies of WHO
  • World Health Assembly
  • Executive Board
  • Secretariat
  • WHO Structure
  • How does WHO function
  • WHO collaborating centers
  • Contribution of WHO to Health Care systems
Types of Clinical Trial

Learners' Request - CR
Video Lesson
  • Introduction to Clinical Trial
  • Types of Clinical Trial with examples:
                      Prevention trial
                      Treatment trial
                      Screening trial
                      Diagnostic trial
                      Behavioral trial
  • Quality of life trial (Supportive care trial)
Research Idea to Research Protocol

Learners' Request - CR
Video Lesson
  • Introduction to Research protocol
  • Need/Importance of Research protocol
  • Origin/generation of Research Idea with examples
  • Creation of research topic
  • Review of research topic for significance and feasibility 
  • Creation of hypothesis and research question
  • Characteristics of a good research question - FINER Criteria
  • Discussion on research objective, variables, research design, outcomes and other research elements which are required for protocol drafting
Bioavailability & Bioequivalence

Learners' Request - CR
Video Lesson
  • Introduction to Bioavailability (BA)  
  • Example of Bioavailability 
  • Application of Bioavailability 
  • Benefits of Bioavailability Studies 
  • Introduction to Bioequivalence (BE) 
  • Application of Bioequivalence 
  • Benefits of Bioequivalence 
  • Importance of Bioavailability & Bioequivalence Studies
Content of Periodic Safety Update Report (PSUR)

Learners' Request - PV
Video Lesson

  • 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 
CRO Vs SMO Learners' Request - CR
Video Lesson
  • Introduction of CRO
  • Definition of CRO
  • Introduction of SMO
  • Definition of SMO
  • Responsibilities of CRO & SMO
  • Relation between CRO & SMO
  • Comparative study of CRO & SMO
Discrepancy Management
Learners' Request - CDM
Video Lesson
  • Discrepancy Management - Introduction
  • Importance/Need of Discrepancy Management
  • Introduction to Discrepancy with examples
  • Generation of Discrepancies in Clinical trial
  • Identification of Discrepancies
  • Kinds of Discrepancies
  • System generated
  • User generated
  • Resolution of Discrepancies in:
  • EDC system
  • Paper-based study
Electronic Common Technical Document (eCTD )
Learners' Request - PV
Video Lesson
  • Introduction to Electronic Common Technical Document (eCTD )
  • Introduction to CTD
  • Importance of eCTD
  • Use of eCTD
  • Structure of eCTD
  • Benefits of eCTD
Endpoints in Clinical Trial
Learners' Request - CR
Video Lesson
  • Introduction to Endpoints
  • Examples of Endpoints
  • Introduction to Outcomes
  • Brief discussion on different kinds of Endpoints used in Clinical Trial:
  • Primary Endpoint
  • Secondary Endpoint
  • Clinical/Direct Endpoint
  • Surrogate Endpoint
  • Hard Endpoint
  • Soft Endpoint
  • Composite/Combined Endpoint
ICSR Nullification
Learners' Request - PV
Video Lesson
  • 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
Investigational New Drug Application (INDA)

Learners' Request - PV
Video Lesson
  • Introduction to INDA
  • When to submit INDA?
  • Purpose of INDA
  • Types of INDA
  • Categories of INDA
  • Contents of INDA
  • INDA Process
Informed Consent Process

Learners' Request - CR
Video Lesson
  • Introduction to Informed Consent Process
  • Definition of Informed Consent Process 
  • Importance of Informed Consent
  • Need of Informed Consent 
  • Elements of Informed Consent 
  • Content of Informed Consent Form
  • Details of Informed Consent Process
Local Lab Vs Central Lab

Learners' Request - CR
Video Lesson
  • Introduction to Local laboratory
  • Functions of Local laboratory
  • Advantages and disadvantages of Local laboratory
  • Introduction to Central laboratory
  • Functions of Central laboratory
  • Advantages and disadvantages of Central laboratory
  • Comparative study of Local laboratory and Central laboratory
Medical Device Reporting - US

Learners' Request - PV
Video Lesson

  • 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
Naranjo Algorithm

Learners' Request - PV
Video Lesson
  • Causality assessment - Introduction
  • Naranjo Algorithm - Introduction
  • Brief discussion on questions used in Naranjo Algorithm
  • How to use Naranjo Algorithm
  • Benefits and limitations of Naranjo Algorithm
New Drug Application (NDA)

Learners' Request - PV
Video Lesson
  • Introduction to NDA
  • Importance/Need of NDA
  • When to Submit NDA
  • Data included in NDA
  • NDA Process
Product Complaint

Learners' Request - CR
Video Lesson
  • Introduction to product complaint
  • Example of product complaint
  • Categorization of product complaint
  • Sources of product complaint
  • Complaint management
  • Complaint handling process-Overview
Pharmacovigilance Program of India (PvPI)

Learners' Request - PV
Video Lesson
  • 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
Qualified Person for PV (QPPV)

Learners' Request - PV
Video Lesson
  • 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)}
Research Protocol


Learners' Request - CR

Video Lesson
  • Introduction to Research Protocol
  • Definition of Research Protocol
  • Need of Research Protocol
  • Importance of Research Protocol
  • Preparation of Research Protocol
  • Content of Research Protocol
  • Points to consider while creating Research Protocol
  • Research Protocol amendment
  • Protocol Exception, Deviations & Violations
Safety Data Exchange Agreement (SDEA)

Learners' Request - PV
Video Lesson
  • Introduction to Safety Data Exchange Agreement (SDEA)
  • Need of SDEA
  • Importance of SDEA
  • Preparation of SDEA
  • Points to be included in SDEA
Safety Monitoring during Clinical Trial

Learners' Request - PV
Video Lesson
  • 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
Signal Detection

Learners' Request - PV
Video Lesson
  • Signals in Pharmacovigilance
  • Introduction to Signal detection 
  • Sources of Signals
  • Methods of Signal detection
  • Importance of Signal detection
  • Signal Management Process -Definition
Source Document & Source Data

Learners' Request - CR
Video Lesson
  • Importance of proper and efficient documentation
  • Introduction to Source document
  • Example of Source document
  • Types of Source document
  • Purpose of Source document
  • Introduction to Source data
  • ALCOA - explained
Trial Master File

Learners' Request - CR
Video Lesson
  • Introduction to TMF
  • Need of TMF
  • Importance of TMF
  • When to prepare TMF
  • Points to consider while preparing TMF
  • TMF content
  • Documents included in TMF
  • Maintenance of TMF
Site Management Organization

Learners' Request - CR
Video Lesson
  • Introduction to SMO
  • Scope of SMO
  • Need of SMO
  • SMO Services
  • Benefits of SMO
  • Points to remember to be a good SMO
Principal Investigator (PI)

Learners' Request - CR
Video Lesson
  • Principal Investigator -Introduction
  • Responsibilities of Principal Investigator
  • Selection of Principal Investigator/ Requirements to become Principal Investigator
  • Qualities of a good Principal Investigator
Scope of Pharmacovigilance (PV)

Learners' Request - PV
Video Lesson
  • Introduction of Pharmacovigilance
  • Need of PV
  • Issues (related to medicinal product) covered under PV
  • Products covered under PV
  • Application of PV in pre-market and post-market stage
AE Vs ADR

Learners' Request - PV
Video Lesson

  • 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
Side Effect Vs Adverse Effect

Learners' Request - PV
Video Lesson
  • Introduction to Side effect
  • Example of Side effect
  • Introduction to Adverse effect
  • Example of Adverse effect
  • Differences between Side effect and Adverse effect
United States of America (USA) Short Notes - Bundle 1 Document - Read
  • Food and Drug Administration (FDA)
  • Responsibilities of FDA
  • Products regulated by FDA   
  • Vaccine Adverse Event Reporting System (VAERS) 
  • FDA Adverse Event Reporting System (FAERS) 
  • Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA Regulations, and FDA Guidance
  • Centers for Disease Control and Prevention (CDC)   
  • National Institutes of Health (NIH) 
  • Health and Human Services (HHS)  
India Short Notes - Bundle 1
Document - Read

  • Central Drugs Standard Control Organization (CDSCO)
  • Indian Pharmacopoeia Commission (IPC)
  • Pharmacovigilance Programme of India (PvPI)
  • Materiovigilance Programme of India (MvPI) 
  • Haemovigilance Programme of India (HvPI)
World Health Organization (WHO) Short Notes - Bundle 1
Document - Read

  • World Health Organization (WHO)
  • WHO Programme for International Drug Monitoring (WHO PIDM)
  • VigiBase,  VigiFlow,   VigiAccess,   VigiLyze,   
  • WHO Drug Global   
  • WHO Drug Information
European Medicines Agency (EMA)
Short Notes - Bundle 1
Document - Read

  • European Medicines Agency (EMA)
  • EudraVigilance Authorization of Medicines in the European Union (EU)
  • Centralized Authorization Procedure Scope of Centralized Procedure
  • National Competent Authority (Human)
  • Mutual Recognition Procedure (MRP)
  • Decentralized Procedure (DCP)
  • European Commission
  • European Medicines Regulatory Network 
  • EMA - Organization
  • Referral Procedure
International Council for Harmonization (ICH)
Short Notes - Bundle 1
Document - Read

  • International Council for Harmonization  
  • Organization of ICH 
  • ICH Guidelines
  • Common Technical Document (CTD)
CIOMS - Council for International Organizations of Medical Sciences
Short Notes - Bundle 1
Document - Read

  • Council for International Organizations of Medical Sciences (CIOMS) 
  • CIOMS Forms
  • CIOMS Working Groups (WGs)
  • CIOMS Members
Causality Assessment PV - Concept Capsule Video Lesson
  • Introduction to Causality Assessment
  • Need of Causality assessment in PV
  • Aim of causality assessment 
  • How to do Causality assessment
  • Importance of Causality assessment
Methods of Causality Assessment PV - Concept Capsule
Video Lesson Methods of Causality assessment:
          Clinical judgment or global introspection
          Algorithms
          Probabilistic methods
Case Narrative or Patient Narrative
Learners' Request - PV Video Lesson
  • 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
Good Clinical Practice (GCP) Guidelines Learners' Request - CR
Video Lesson
  • Good Clinical Practice (GCP) Guidelines -introduction
  • Origin of GCP
  • Objective of GCP
  • Benefits of GCP
  • GCP Guidelines- Development
  • Importance of GCP Training
  • ICH-GCP Guidelines
CIOMS Form Learners' Request - PV
Video Lesson
  • 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
ICSR (Individual Case Safety Report) Learners' Request - PV
Video Lesson
  • Introduction to ICSR
  • Generation of ICSR
  • Sources of ICSR
  • Voluntary forms and Mandatory forms
  • Minimum Criteria for a valid ICSR
  • ICSR processing
VigiFlow
Learners' Request - PV
Video Lesson
  • Introduction to VigiFlow
  • Need of VigiFlow
  • Development of VigiFlow
  • Organization of VigiFlow
  • How is Vigiflow used
  • Importance of VigiFlow
MedWatch Forms
Learners' Request - PV
Video Lesson
  • 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
Data Safety Monitoring Board (DSMB)
Learners' Request - CR
Video Lesson
  • Introduction to  DSMB
  • Formation of DSMB
  • Role of DSMB
  • How does DSMB work
  • Characteristics of DSMB
  • Need of DSMB
Types of Adverse Drug Reactions (ADRs)
PV - Concept Capsule
Video Lesson
  • 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
Clinical Trial – Phases

Learners' Request - CR
Video Lesson
  • Introduction of Clinical trials
  • Phases of Clinical trials:
    • Phase 0
    • Phase I
    • Phase II
    • Phase III
    • Phase IV
Severe Adverse Event Vs. Serious Adverse Event
Learners' Request - PV
Video Lesson
  • 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
Argus Safety System
Learners' Request - PV
Video Lesson
  • 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
  MedDRA Part 1  
Concept Capsule - PV Video Lesson 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  

Testimonials

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

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