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 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 with example focusing 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&mn
3=7297
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