Concept of Pharmacovigilance - Video Lesson

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

Adverse Drug Reaction (ADR) - 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) - Video Lesson

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

Conditions to consider an event/reaction "Unexpected" - Video Lesson

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

Effect of Medicinal Product - 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 - 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    

• 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) - 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 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 - Video Lesson

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

• 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) - Video Lesson

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

• 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 - 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

• 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 - Video Lesson

• Introduction to Central laboratory
• Need of Central laboratory
• Importance of Central laboratory
• How does Central laboratory work
• Benefits of Central laboratory

• 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 - Video Lesson

• Introduction to CRC
• Introduction to CRA
• CRC functions, roles and responsibilities
• CRA functions, roles and responsibilities
• Comparative study of CRC and CRA

• 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 - 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)

• 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) - 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

• 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 - 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

• 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) - 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 

Contract Research Organization (CRO) - Video Lesson

CRO Vs SMO - 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

Sponsor - Video Lesson

Discrepancy Management - 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) - 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 - 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 - 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) - 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 - 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 - 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 - 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 - 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) - Video Lesson

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

Product Complaint - 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) - 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) - 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 - 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) - 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 - 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 - 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 - 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 - 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 - 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) - 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) - 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 - 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 - 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

• 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

• 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

• 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

• 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

• International Council for Harmonization
• Organization of ICH
• ICH Guidelines
• Common Technical Document (CTD)

CIOMS - Council for International Organizations of Medical Sciences - Short Notes

• Council for International Organizations of Medical Sciences (CIOMS)
• CIOMS Forms
• CIOMS Working Groups (WGs)
• CIOMS Members

Causality Assessment - 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 - Video Lesson

• Clinical judgment or global introspection
• Algorithms
• Probabilistic methods

Case Narrative or Patient Narrative - 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 - 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 - 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) - 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 - Video Lesson

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

MedWatch Forms - 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) - 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) - 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 - 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 - 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 - 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 - 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

MedDRA Part 2 - Video Lesson

• Structure of MedDRA
• System Organ Classes (SOCs)
• High Level Group Term (HLGT)
• High Level Term (HLT)
• Preferred Term (PT)
• Lowest Level Term (LLT)
• MedDRA Structure - Example
• LLT relation to PT Multiaxiality (explained with example)
• Coding of terms in MedDRA explained with example
• Advantage of MedDRA coded terms

Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs) - Video Lesson

• Introduction to Risk Management System
• Risk Evaluation and Mitigation Strategies (REMS)
• Elements of REMS
• REMS- Example
• Risk Management Plans (RMPs)
• Elements of RMP
• RMP- Example
• Comparative study of REMS and RMP

MedDRA Part 3.1 - Video Lesson

• MedDRA coding conventions -Introduction
• Need of Coding conventions and principles
• MedDRA conventions:
• Spellings Abbreviation
• Capitalization
• Punctuation
• Word order
• MedDRA Codes
• Numerical values
• NOS & NEC terms

MedDRA Part 3.2 - Video Lesson

Coding Principles used in a MedDRA dictionary

• Quality of Source Data and Quality Assurance
• Do Not Alter MedDRA
• Always Select a Lowest Level Term and Select Only Current Lowest Level Terms
• Use of Medical Judgment in Term Selection and When to Request a Term Check the Hierarchy
• Select Terms for All Reported Information and Do not Add or Subtract Information
• Selecting More than One Term

Clinical Research Coordinator (CRC) - Video Lesson

• CRC - Introduction
• Roles and responsibilities of CRC
• Educational requirements to become a CRC
• Required skills to become a CRC
• Organizations where CRC can work

Difference between drug misuse and drug abuse - Video Lesson

• Drug misuse -Introduction
• Drug misuse - Example
• Drug abuse -Introduction
• Drug abuse - Example
• Difference between Drug misuse and Drug abuse
• Examples of serious consequences of drug misuse and drug abuse

Signals In Pharmacovigilance - Video Lesson

• Pharmacovigilance Signal – Definition
• Pharmacovigilance Signal - Explained
• Sources of Pharmacovigilance Signals
• Unsolicited sources
• Solicited sources
• Contractual agreements
• Regulatory authority sources
• Types of Pharmacovigilance Signal
• Qualitative (Clinical) signals
• Quantitative (Statistical) signals
• Signal Management Process
• Importance of Pharmacovigilance Signal

Drug Dependence vs Drug Addiction - Video Lesson

• Drug dependence -Introduction
  
• Drug dependence -Example
  
• Drug addiction -Introduction
  
• Drug addiction -Example
  
• Key differences between Drug dependence & Drug addiction - Summarized
  

Role of Ethics committee in Clinical Research - Video Lesson

• Introduction to Ethics Committee
  
• Structure of Ethics Committees
  
• Institutional Ethics Committee (Institutional Review Board)
  
• Independent Ethics Committee
  
• Constitution of Ethics Committee
  
• Objective of Ethics Committee
  
• Role of Ethics Committees in Clinical Research