Pharmacovigilance Unit 4 Notes Safety data generationPreclinical phaseClinical phasePostapproval phase (PMS) ICH Guidelines for PharmacovigilanceOrganization and objectives of ICHExpedited reportingIndividual […]
Pharmacovigilance Unit 3 Notes Vaccine safety surveillanceVaccine PharmacovigilanceVaccination failureAdverse events following immunization Pharmacovigilance methodsPassive surveillance– Spontaneous reports and case seriesStimulated
Pharmacovigilance Unit 2 Notes Drug and disease classificationAnatomical, therapeutic and chemical classification of drugsInternational classification of diseasesDaily defined dosesInternational Non
Pharmacovigilance Unit 1 Notes Introduction to PharmacovigilanceHistory and development of PharmacovigilanceImportance of safety monitoring of MedicineWHO international drug monitoring programmePharmacovigilance
Pharmaceutical Regulatory Science Unit 5 Notes Regulatory ConceptsBasic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code
Pharmaceutical Regulatory Science Unit 4 Notes Clinical trialsDeveloping clinical trial protocols, Institutional Review Board / Independent Ethics committee- formation and
Pharmaceutical Regulatory Science Unit 3 Notes Registration of Indian drug product in overseas marketProcedure for export of pharmaceutical products, Technical
Pharmaceutical Regulatory Science Unit 2 Notes Regulatory Approval ProcessApproval processes and timelines involved in Investigational New Drug (IND), New Drug
Pharmaceutical Regulatory Science Unit 1 Notes New Drug Discovery and developmentStages of drug discovery, Drug development process, pre-clinical studies, non-clinical
Pharma Marketing ManagementUnit 5 Notes Pricing :Meaning, importance, objectives, determinants of price; pricing methods and strategies, issues in price management