Pharmacovigilance Books
| Author’s Name | Dr. Agnimitra Dinda and Monika Saxena |
| Editions | Latest Edition |
| Publishers | Thakur Publication Ltd |
CURRENT TRENDS IN PHARMACOVIGILANCE (SEM -VIII) B.PHARM
| Author’s Name | VARUN AND DEEPAK PRAGI |
| Editions | Latest Edition |
| Publishers | S VIKAS AND COMPANY (PV) |
PHARMACOVIGILANCE SEM VIII
| Author’s Name | Dr. D. K. Tripathi, Dr. Shiv Shankar Shukla, Dr. Ravindra Kumar Pandey |
| Editions | First Edition |
| Publishers | Nirali Prakashan |
Pharmacovigilance Topic-wise Summary
Introduction to Pharmacovigilance
- History and development of Pharmacovigilance
- Importance of safety monitoring of medicines
- WHO International Drug Monitoring Programme
- Pharmacovigilance Program of India (PvPI)
Introduction to Adverse Drug Reactions (ADRs)
- Definitions and classification of ADRs
- Detection and reporting
- Methods in causality assessment
- Severity and seriousness assessment
- Predictability and preventability assessment
- Management of adverse drug reactions
Basic Terminologies Used in Pharmacovigilance
- Terminologies of adverse medication-related events
- Regulatory terminologies
Drug and Disease Classification
- Anatomical, Therapeutic, and Chemical classification of drugs
- International Classification of Diseases (ICD)
- Daily Defined Doses (DDD)
- International Non-Proprietary Names (INN) for drugs
Drug Dictionaries and Coding in Pharmacovigilance
- WHO Adverse Reaction Terminologies
- MedDRA and Standardised MedDRA Queries (SMQs)
- WHO Drug Dictionary
- Eudravigilance Medicinal Product Dictionary
Information Resources in Pharmacovigilance
- Basic drug information resources
- Specialised resources for ADRs
Establishing Pharmacovigilance Programmes
- Establishing in a hospital
- Establishment and operation of drug safety departments in industry
- Contract Research Organisations (CROs)
- Establishing a national programme
Vaccine Safety Surveillance
- Vaccine Pharmacovigilance
- Vaccination failure
- Adverse events following immunization (AEFI)
Pharmacovigilance Methods
- Passive surveillance: Spontaneous reports and case series
- Stimulated reporting
- Active surveillance: Sentinel sites, drug event monitoring, registries
- Comparative observational studies:
- Cross-sectional study
- Case-control study
- Cohort study
- Cross-sectional study
- Targeted clinical investigations
Communication in Pharmacovigilance
- Effective communication in Pharmacovigilance
- Communication in drug safety crisis management
- Communicating with regulatory agencies, business partners, healthcare facilities, and media
Safety Data Generation
- Pre-clinical phase
- Clinical phase
- Post-approval phase (PMS)
ICH Guidelines for Pharmacovigilance
- Organization and objectives of ICH
- Expedited reporting
- Individual Case Safety Reports (ICSRs)
- Periodic Safety Update Reports (PSURs)
- Post-approval expedited reporting
- Pharmacovigilance planning
- Good Clinical Practice (GCP) in pharmacovigilance studies
Pharmacogenomics of Adverse Drug Reactions
- Genetics-related ADRs with examples focusing on pharmacokinetic (PK) parameters
Drug Safety Evaluation in Special Populations
- Paediatrics
- Pregnancy and lactation
- Geriatrics
CIOMS (Council for International Organizations of Medical Sciences)
- CIOMS Working Groups
- CIOMS Form
CDSCO (India) and Pharmacovigilance
- Drugs & Cosmetics Act and Schedule Y
- Differences in Indian and global pharmacovigilance requirements