{"product_id":"9789355851949-2","title":"Pharmacovigilance -  for  B. PHARMACY  PCI SYLLABUS - 17  ( SEM VIII - BP805ET) - TEXTBOOK","description":"\u003cp\u003eSyllabus Pharmacovigilance UNIT - I •\tIntroduction to Pharmacovigilance : History and development of Pharmacovigilance, Importance of safety monitoring of Medicine, WHO international drug monitoring programme, Pharmacovigilance Program of India(PvPI). (Chapter - 1) •\tIntroduction 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. (Chapter - 2) •\tBasic terminologies used in pharmacovigilance : Terminologies of adverse medication related events, Regulatory terminologies. (Chapter - 3) UNIT-II  •\tDrug and disease classification : Anatomical, therapeutic and chemical classification of drugs, International classification of diseases, Daily defined doses, International Non proprietary Names for drugs. (Chapter - 4) •\tDrug dictionaries and coding in pharmacovigilance : WHO adverse reaction terminologies, MedDRA and Standardised MedDRA queries, WHO drug dictionary, Eudravigilance medicinal product dictionary. (Chapter - 5) •\tInformation resources in pharmacovigilance : Basic drug information resources, Specialised resources for ADRs. (Chapter - 6) •\tEstablishing pharmacovigilance programme : Establishing in a hospital, Establishment \u0026amp; operation of drug safety department in industry, Contract Research Organisations (CROs), Establishing a national programme (Chapter - 7) UNIT- III •\tVaccine safety surveillance : Vaccine Pharmacovigilance, Vaccination failure, Adverse events following immunization. (Chapter - 8) •\tPharmacovigilance 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. (Chapter - 9) •\tCommunication in pharmacovigilance : Effective communication in Pharmacovigilance, Communication in Drug Safety Crisis management, Communicating with Regulatory Agencies, Business Partners, Healthcare facilities \u0026amp; Media. \t (Chapter - 10) UNIT-IV •\tSafety data generation : Pre clinical phase, Clinical phase, Post approval phase (PMS). (Chapter - 11) •\tICH 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. (Chapter - 12) UNIT- V •\tPharmacogenomics of adverse drug reactions : Genetics related ADR with example focusing PK parameters, Drug safety evaluation in special population, Paediatrics, Pregnancy and lactation, Geriatrics. (Chapter - 13) •\tCIOMS : CIOMS Working Groups, CIOMS Form. (Chapter - 14) •\tCDSCO (India) and Pharmacovigilance : D\u0026amp;C Act and Schedule Y, Differences in Indian and global pharmacovigilance requirements. (Chapter - 15)\u003c\/p\u003e","brand":"Technical Publications","offers":[{"title":"Default Title","offer_id":46828241682603,"sku":"11959613194","price":475.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0620\/3355\/9723\/files\/9789355851949_1_4e08c388-37d6-49e7-ab62-4cf5f8036c15.jpg?v=1778239035","url":"https:\/\/technicalpublications.in\/products\/9789355851949-2","provider":"Technical Publications","version":"1.0","type":"link"}