November 28, 2023

805T Pharmacovigilance Theory Notes, PDF Books, Syllabus, MCQ, Video lectures

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, therapeutic and 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 Working Groups
 CIOMS Form

CDSCO (India) and Pharmacovigilance
 D&C Act and Schedule Y
 Differences in Indian and global pharmacovigilance requirements

  1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.
  2. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and Bartlett Publishers.
  3. Mann’s Pharmacovigilance:Elizabeth B. Andrews, Nicholas, Wiley Publishers.
  4. Stephens’ Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley Publishers.
  5. An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers.
  6. Cobert’s Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones & Bartlett Publishers.
  7. Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel,Sean Hennessy,Wiley Publishers.
  8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G. Parthasarathi, Karin NyfortHansen,Milap C. Nahata
  9. National Formulary of India
  10. Text Book of Medicine by Yashpal Munjal
  11. Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK Manna

Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise

Final Year B Pharm Sem VIIBP701T Instrumental Methods of Analysis Theory
BP702T Industrial Pharmacy TheoryBP703T Pharmacy Practice Theory
BP704T Novel Drug Delivery System TheoryBP705 P Instrumental Methods of Analysis Practical
Final Year B Pharm Sem VIIBP801T Biostatistics and Research Methodology Theory
BP802T Social and Preventive Pharmacy TheoryBP803ET Pharmaceutical Marketing Theory
BP804ET Pharmaceutical Regulatory Science TheoryBP805ET Pharmacovigilance Theory
BP806ET Quality Control and Standardization of Herbals TheoryBP807ET Computer-Aided Drug Design Theory
BP808ET Cell and Molecular Biology TheoryBP809ET Cosmetic Science Theory
BP810ET Experimental Pharmacology TheoryBP811ET Advanced Instrumentation Techniques Theory
BP812ET Dietary supplements and NutraceuticalsPharmaceutical Product Development

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