Syllabus
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Course Code: BP805ET Course Name: Pharmacovigilance |
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| MODULE NO / UNIT | COURSE SYLLABUS CONTENTS OF MODULE | NOTES |
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| 1 | 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 |
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| 2 | 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 terminologiesv • 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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| 3 | 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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| 4 | 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 |
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| 5 | 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 |
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