Pharmacovigilance

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Buy Thakur Publication’s Pharmacovigilance book for B.Pharm 8th Sem as per Latest Syllabus of PCI. Pharmacovigilance textbook covered all important topics. This is the best book for Pharmacovigilance.

The Pharmacovigilance book is a comprehensive guide to the principles and practices of drug safety monitoring.

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It covers topics such as adverse drug reactions, signal detection, risk management, regulatory requirements, and pharmacovigilance systems. The book provides practical knowledge and skills for pharmacovigilance professionals to ensure the safety of medicines in use.

AUTHORS- Dr. Agnimitra Dinda, Monika Saxena

ISBN- 978-93-90972-83-8

                                                                        Syllabus

Pharmacovigilance

 (Course Code: BP805ET)

Module 01                                                                                                                           10 Hours

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.

 

Module 02                                                                                                                           10 Hours

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.

 

Module 03                                                                                                                          10 Hours

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.

 

Module 04                                                                                                                           08 Hours

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.

 

Module 05                                                                                                                           07 Hours

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.

 

PCI2021/B.Pharm/8/05
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