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Establishing a National ProgrammePharmacovigilanceUnit 2 pharmacovigilance national program
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Establishing a National programme:- It involves creating a systematic framework at a country level to monitor, evaluate and ensure the safety of medication used within the population aiming to detect, assess, understand and prevent ADRs. • Discussion on: • 1. Establishing a national programme • 2. policy development • 3. legislation and regulations • 4. infrastructure setups • 5. capacity building • 6. surveillance systems • 7. reporting mechanisms • 8. data analysis and signal detection • 9. risk communications • 10. collaboration and networking • 11. international cooperation • 12. Quality assurance and audit • 13. continuous improvement • • For written notes 👇 click on link • https://t.me/drjitendrapatelclasses • Importance of safety monitoring of Medicine • • Importance of safety monitoring of me... • History and Development of Pharmacovigilance • • History and Development of Pharmacovi... • WHO International drug monitoring programme • • WHO International drug monitoring pro... • Pharmacovigilance program of India • • Pharmacovigilance program of India| P... • Definition and Classification of Adverse drug reactions • • Definition and Classification of Adve... • Methods of causality assessment • • Methods of causality assessment|Pharm... • Predictability and Preventability Assessments • • Predictability and Preventability Ass... • Management of adverse drug reaction • • Management of adverse drug reactions|... • Anatomical therapeutical chemical classifications • • Anatomical therapeutical chemical c... • International classification of Disease • • International classification of Disea... • International classification of Disease • • International classification of Disea... • Daily Defined Dose • • Daily Defined Dose|pharmacovigilance|... • International nonproprietary names of Drugs • • International nonproprietary names of... • Drug dictionaries and coding in Pharmacovigilance • • Drug dictionaries and coding in Pharm... • MedDRA, Standardized MedDRA queries • • MedDRA|standardized MedDRA queries|ph... • WHO drug dictionary • • WHO drug dictionary|pharmacovigilance... • Eudravigilance medicinal products dictionaries • • Eudravigilance medicinal products dic... • Basic drug information resources • • Basic drug information resources|Info... • Specialised resources for ADRs • • Specialised resources for ADRs|Pharma... • Establishing in a Hospital • • Establishing in a Hospital|Establishi... • Establishing Operation of drug safety department in Industry • • Establishing Operation of drug safe... • Establishing a National Programme • • Establishing a National Programme|Pha... • Vaccine safety surveillance • • Vaccine safety surveillance|Vaccine P... • Vaccination Failure • • Vaccination Failure|vaccine safety su... • Adverse events following immunization • • Adverse events following immunization... • Pharmacovigilance methods • • Pharmacovigilance methods|passive sur... • Stimulated reporting • • Stimulated reporting|pharmacovigilanc... • Active surveillance • • Active surveillance|sentinel sites|dr... • Comparative observational studies| • • Comparative observational studies|Cro... • Case-Control study • • Case-Control study|Pharmacovigilance|... • Cohort study • • Cohort study|Pharmacovigilance|Unit 3... • Targeted clinical investigation • • Targeted clinical investigation|Pharm... • Communication in pharmacovigilance| • • Communication in pharmacovigilance|Ef... • Communication in Drug safety Crisis • • Communication in Drug safety Crisis M... • Communicating with regulatory agencies • • Communicating with regulatory agencie... • Safety data generation • • Safety data generation|pharmacovigila... • ICH guidelines for pharmacovigilance • • ICH guidelines for pharmacovigilance|... • Expedited Reporting • • Expedited Reporting|pharmacovigilance...
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