Pharmacovigilance Mastery
Pharmacovigilance and Adverse Drug Reaction Management
Pharmacovigilance and Adverse Drug Reaction Management
Pharmacovigilance and Adverse Drug Reaction Management
I. Introduction to Adverse Drug Reactions
- Definition and Classification of Adverse Drug Reactions
- Detection and Reporting of Adverse Drug Reactions
- Management of Adverse Drug Reactions
- Causality Assessment
- Severity and Seriousness Assessment
- Predictability and Preventability Assessment
Introduction to Pharmacovigilance
- History and Development of Pharmacovigilance
- Importance of Safety Monitoring / Why Pharmacovigilance?
- National and International Scenario
- Pharmacovigilance in India
- Pharmacovigilance - Global Perspective
- WHO International Drug Monitoring Programme
Basic Terminologies in Pharmacovigilance
- Terminologies of Adverse Medication-Related Events
- Regulatory Terminologies
Information Resources in Pharmacovigilance
- Basic Drug Information Resources
- Specialized Resources for Adverse Drug Reactions
- Critical Evaluation of Medication Safety Literature
II. Establishing a Pharmacovigilance Program
- Establishment of a Pharmacovigilance Centre in a Hospital
- Establishment & Operation of Drug Safety Department in Industry
- Establishing a National Pharmacovigilance Program
- SOPs – Types, Designing, Maintenance, and Training
- Roles and Responsibilities in Pharmacovigilance
- License Partners, CROs, and Market Authorization Holders (MAH)
Pharmacovigilance Methods
- Passive Surveillance – Spontaneous Reports and Case Series
- Intensified Reporting
- Active Surveillance – Targeted Reporting, Cohort Event Monitoring, and Electronic Health Record Mining
- Comparative Observational Studies – Cross-Sectional Study, Case-Control Study, and Cohort Study
- Targeted Clinical Investigations
- Vaccine Safety Surveillance
III. Adverse Drug Reaction Reporting
- Introduction to Reporting Systems
- Spontaneous Reporting System
- Reporting to Regulatory Authorities
- Guidelines for Reporting Adverse Drug Reactions
Signal Detection, Risk Assessment, and Management
- Identification of New Adverse Drug Reactions
- Signal Detection in Pre and Post Marketing Period
- Prioritization and Risk Assessment
- Risk Management
Drug and Disease Classification
- International Classification of Diseases (ICD)
- Anatomical, Therapeutic, and Chemical Classification of Drugs
- Defined Daily Dose (DDD)
- International Non-proprietary Names (INN) for Drugs
IV. Drug Dictionaries and Coding in Pharmacovigilance
- WHO Adverse Reaction Terminologies
- MedDRA and Standardized MedDRA Queries
- WHO Drug Dictionary
- Eudravigilance Medicinal Product Dictionary
Communication in Pharmacovigilance
- Effective Communication in Pharmacovigilance
- Communication in Drug Safety Crisis Management
- Communicating with Regulatory Agencies, Business Partners, Healthcare Facilities & Media
- "Dear Doctor" Letters to Healthcare Professionals
Tools Used in Pharmacovigilance
- Introduction to Argus
- Introduction to Aris G
V. Drug Informatics
- Basic Prescribing Information (BPI) Labeling
- EMEA Labeling
- Investigator’s Brochure (IB) Labeling
Seriousness Assessment Criteria
- Event Verbatim
- CTCAE Guidelines
Statistical Methods for Evaluating Medication Safety Data
- Pharmacogenomics of Adverse Drug Reactions
Regulatory Perspectives of Pharmacovigilance
Pharmacovigilance and Adverse Drug Reaction Management
Pharmacovigilance and Adverse Drug Reaction Management
Module 1: Safety Data Generation
- Phases: Pre-clinical, Clinical, Post-approval
- Safety Monitoring: Importance, terminologies, roles & responsibilities
- Special Populations: Paediatrics, Pregnancy, Lactation, Geriatrics
Module 2: ICH Guidelines for Pharmacovigilance
- Expedited Reporting
- Case Safety Reports: Individual & Periodic Updates
- Post-Approval Reporting & Planning
- Safety Reporting in Clinical Study Reports
- Foreign Data Acceptability & Safety Bridging Studies
Module 3: Global Organizations in Pharmacovigilance
- Key Organizations: CIOMS, US FDA, EMEA, MHLW, Health Canada, CDSCO
- Global Guidelines: Focus on CFR (FDA), EMEA (Europe), and CDSCO (India)
- Regulatory Requirements
Module 4: Case Narratives
- Regulatory Writing Perspectives
- Narratives from Clinical Trials, Spontaneous Reporting & Literature
- Quality Assessment of Narratives
Module 5: Quality Assurance & Compliance
- QA Aspects: Critical errors, delays, product quality complaints
- Pharmacovigilance Inspections & Audits
- Legal Case Processing: Adverse event form completion, legal writing, reporting