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

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):

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
12. http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn3=7297
13. http://www.ich.org/
14. http://www.cioms.ch/
15. http://cdsco.nic.in/
16. http://www.who.int/vaccine_safety/en/
17. http://www.ipc.gov.in/PvPI/pv_home.html

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

Suggested readings

• BP210P Computer Applications in Pharmacy Practical
• Cosmetics as quasi and OTC drugs
• BP107P Human Anatomy and Physiology Practical
• BP201T Human Anatomy and Physiology II Theory Syllabus
• History of the profession of Pharmacy in India in relation to pharmacy education, industry, and organization
• human anatomy and physiology