Preview to Lessons on Learners' Request - PV - 29 Lessons
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
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
21 CFR Part 11
- Introduction to CFR
- Organization of CFR
- Brief discussion on Subparts of 21 CFR Part 11: Subpart A -General Provisions
- Role of 21 CFR Part 11
Subpart B -Electronic Records
Subpart C -Electronic Signatures
AESI (Adverse Event of Special Interest)
- AESI explained with an example
- Sources of AESI
- Handling of AESI with example
- Significance of studying AESI
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
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
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
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
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
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
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
New Drug Application (NDA)
- Introduction to NDA
- Importance/Need of NDA
- When to Submit NDA
- Data included in NDA
- NDA Process
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
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)}
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
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
Signal Detection
- Signals in Pharmacovigilance
- Introduction to Signal detection
- Sources of Signals
- Methods of Signal detection
- Importance of Signal detection
- Signal Management Process -Definition
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
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
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
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
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
VigiFlow
- Introduction to VigiFlow
- Need of VigiFlow
- Development of VigiFlow
- Organization of VigiFlow
- How is Vigiflow used
- Importance of VigiFlow
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
- FDA MedWatch learn
MedWatch form 3500
MedWatch form 3500 B
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
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
REMS Vs RMP
- 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
Drug Dependence vs Drug Addiction
- Drug dependence -Introduction
- Drug dependence -Example
- Drug addiction -Introduction
- Drug addiction -Example
- Key differences between Drug dependence & Drug addiction - Summarized
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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