Pharmacovigilance Theory Notes, PDF Books, Syllabus, MCQ, Video lectures
Unit I
Introduction to Pharmacovigilance
History and development of Pharmacovigilance
Importance of safety monitoring of Medicine
WHO international drug monitoring programme
Pharmacovigilance Program of India(PvPI)
Introduction to adverse drug reactions
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
Unit II
Drug and disease classification:
Anatomical classification of drugs,
Therapeutic classification of drugs,
Chemical classification of drugs
International classification of diseases
Daily defined doses
International Non-proprietary Names for drugs
Drug dictionaries and coding in pharmacovigilance
WHO adverse reaction terminologies
MedDRA and Standardised MedDRA queries
WHO drug dictionary
Eudravigilance medicinal product dictionary
Information resources in pharmacovigilance
Basic drug information resources
Specialised resources for ADRs
Establishing pharmacovigilance programme
Establishing in a hospital
Establishment & operation of drug safety department in the industry
Contract Research Organisations (CROs)
Establishing a national programme
Unit III
Vaccine safety surveillance
Vaccine Pharmacovigilance
Vaccination failure
Adverse events following immunization
Pharmacovigilance methods
Passive surveillance – Spontaneous reports and case series
Stimulated reporting
Active surveillance – Sentinel sites, drug event monitoring and registries
Comparative observational studies – Cross-sectional study, case-control study and cohort 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 & Media
Unit IV
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
Periodic safety update reports
Post-approval expedited reporting
Pharmacovigilance planning
Good clinical practice in pharmacovigilance studies
Unit V
Pharmacogenomics of adverse drug reactions
Genetics related ADR for example focuses on PK parameters.
Drug safety evaluation in special population
Paediatrics
Pregnancy and lactation
Geriatrics
CIOMS
CIOMS Working Groups
CIOMS Form
CDSCO (India) and Pharmacovigilance
D&C Act and Schedule Y
Differences in Indian and global pharmacovigilance requirements
Recommended Books (Latest edition):
- Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.
- Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and Bartlett Publishers.
- Mann’s Pharmacovigilance:Elizabeth B. Andrews, Nicholas, Wiley Publishers.
- Stephens’ Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley Publishers.
- An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers.
- Cobert’s Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones & Bartlett Publishers.
- Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel,Sean Hennessy,Wiley Publishers.
- A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G. Parthasarathi, Karin NyfortHansen,Milap C. Nahata
- National Formulary of India
- Text Book of Medicine by Yashpal Munjal
- Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK Manna
- http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn3=7297
- http://www.ich.org/
- http://www.cioms.ch/
- http://cdsco.nic.in/
- http://www.who.int/vaccine_safety/en/
- http://www.ipc.gov.in/PvPI/pv_home.html
Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise
