B Pharmacy 8th Semester Pharmacovigilance Notes

B.Pharmacy 8th Semester Pharmacovigilance Unit-wise notes covering ADRs, PvPI, WHO drug monitoring, safety surveillance, causality assessment, ICH guidelines, vaccine safety, pharmacogenomics, CIOMS, and CDSCO regulations. Exam-oriented, well-structured content ideal for concept clarity and university exam preparation.

Bachelor of Pharmacy
Semester		8th Semester		Subject		Pharmacovigilance
Syllabus
Unit 1st	Introduction to Pharmacovigilance (a) History and development of Pharmacovigilance (b) Importance of safety monitoring of Medicine (c) WHO international drug monitoring programme (d) Pharmacovigilance Programme of India (PvPI) Introduction to adverse drug reactions (a) Definitions and classification of ADRs (b) Detection and reporting (c) Methods in causality assessment (d) Severity and seriousness assessment (e) Predictability and preventability assessment (f) Management of adverse drug reactions Basic terminologies used in pharmacovigilance (a) Terminologies of adverse medication-related events (b) Regulatory terminologies
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Unit 2nd

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  WHOadversereactionterminologies  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

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Unit 3rd

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

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Unit 4th	Safety data generation  Preclinical phase  Clinical phase  Postapproval phase (PMS) ICH Guidelines for Pharmacovigilance  Organization and objectives of ICH  Expedited reporting  Individual case safety reports  Periodic safety update reports  Postapproval expedited reporting  Pharmacovigilance planning  Good clinical practice in pharmacovigilance studies
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Unit 5th	Pharmacogenomics of adverse drug reactions  Genetics-related ADR with an example focusing 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
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This pharmacovigilance syllabus for the B.Pharmacy 8th semester provides a comprehensive understanding of drug safety monitoring throughout a product’s life cycle. Unit I introduces the history, importance, and global pharmacovigilance systems, including WHO programmes and PvPI, along with detailed concepts of adverse drug reactions, their detection, assessment, management, and regulatory terminology.

Unit II explains drug and disease classification systems, drug dictionaries like MedDRA and WHO-DD, information resources, and the establishment of pharmacovigilance programmes in hospitals, industry, CROs, and at national levels. Unit III focuses on vaccine safety surveillance, AEFI, and various pharmacovigilance methods such as passive, active, and observational studies, along with safety communication strategies. Unit IV covers safety data generation across preclinical, clinical, and post-marketing phases and ICH pharmacovigilance guidelines. Unit V emphasizes pharmacogenomics, drug safety in special populations, CIOMS, and Indian regulatory requirements under CDSCO.

Well-structured notes ideal for concept clarity and university exam preparation.

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