Adverse events following immunization|Vaccine safety surveillance|Unit 3 #pharmacovigilance #adr

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Adverse events following immunization:- AEFI refer to any unwanted medical Occurance that follows immunization, which may or may not have a causal relationship with the vaccine or vaccination process.

Area Described:
1. Adverse events following immunization
2. AFFI example
3. AEFI types
4. Causality assessment in AEFI
5. Reporting in AEFI
6. Monitoring and surveillance on AEFI
7. communication prevention and management of AEFI

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Importance of safety monitoring of Medicine
History and Development of Pharmacovigilance
WHO International drug monitoring programme
Pharmacovigilance program of India
Definition and Classification of Adverse drug reactions
Methods of causality assessment
Predictability and Preventability Assessments
Management of adverse drug reaction
Anatomical therapeutical & chemical classifications
International classification of Disease
International classification of Disease
Daily Defined Dose
International nonproprietary names of Drugs
Drug dictionaries and coding in Pharmacovigilance
MedDRA, Standardized MedDRA queries
WHO drug dictionary
Eudravigilance medicinal products dictionaries
Basic drug information resources
Specialised resources for ADRs
Establishing in a Hospital
Establishing & Operation of drug safety department in Industry
Establishing a National Programme
Vaccine safety surveillance
Vaccination Failure
Adverse events following immunization
Pharmacovigilance methods
Stimulated reporting
Active surveillance
Comparative observational studies|
Case-Control study
Cohort study
Targeted clinical investigation
Communication in pharmacovigilance|
Communication in Drug safety Crisis
Communicating with regulatory agencies
Safety data generation
ICH guidelines for pharmacovigilance
Expedited Reporting
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