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
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
Conditions to consider an event/reaction "Unexpected"
- Understanding of the different conditions in which an adverse event or reaction is considered "unexpected"
Effect of Medicinal Product
- Medicinal Product - Introduction
- Effects of Medicinal Product - Explained with examples
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
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)
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
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
Criteria for Assessing Expectedness
- Understanding of different criteria on the basis of which expectedness/listedness/labeledness of an adverse event/reaction is determined
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
Methods of Causality Assessment
Methods of Causality Assessment:
- Clinical judgment or global introspection
- Algorithms
- Probabilistic methods
WHO Scale
- Introduction to WHO-UMC system
- Basic criteria that comprise WHO-UMC system
- Brief discussion on Categories of WHO-UMC system
Probable
Possible
Unlikely
Unclassified/Conditional
Unassessable/Unclassifiable
Naranjo Algorithm
- Introduction to Naranjo Algorithm
- Need/Importance of Naranjo Algorithm
- Brief discussion on (10) Questions enclosed in Naranjo Algorithm
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
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
MedDRA Part 2
- Structure of MedDRA
- System Organ Classes (SOCs)
- High Level Group Term (HLGT)
- High Level Term (HLT)
- Preferred Term (PT) and
- 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
MedDRA Part 3.1
- MedDRA coding conventions - Introduction
- Need for Coding conventions and principles
- MedDRA conventions:
Spellings Abbreviation
Capitalization
Punctuation
Word order
MedDRA Codes
Numerical values
NOS & NEC terms
MedDRA Part 3.2
- 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
Signals in Pharmacovigilance
- 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
MedDRA Part 3.1
- MedDRA coding conventions - Introduction
- Need for Coding conventions and principles
- MedDRA conventions:
Spellings Abbreviation
Capitalization
Punctuation
Word order
MedDRA Codes
Numerical values
NOS & NEC terms
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