Syllabus – Clinical Research and Pharmacovigilance

Syllabus – Clinical Research and Pharmacovigilance

CLINICAL RESEARCH
  • Introduction of Clinical ResearchIntroduction of Clinical Research
    Clinical Trial Phases
    Pharmacological Principal Of Clinical Research
    Drug Development And Launch
  • Indian Regulation (domestic regulation)ICH GCP
    Schedule Y
    ICMR
    Indian GCP
  • key Stakeholders in Clinical ResearchEthics Committees And Institutional Review Board
    Responsibilities Of Sponsor
    Responsibilities Of Investigator
    Responsibilities Of Sponsor – Investigator
    Responsibilities Of Sponsor – Vendor
  • Clinical Trial Design and Project ManagementsClinical Trial Design
    Vendor Selection And Managements
    Project Planning
    Project Managements
  • Principles of Good Clinical PracticesProtocol Design
    CRF Design
  • Essential documents in Clinical Research and Regulatory RequirementsEssential Documents
    IND Application
    Clinical Study Report
    NDA Application
    Informed Consent process And Documentation
  • Study Setup ProcessSite Selection And Pre- Study VIsits
    Site Initiation
    Subject Recruitment And Retention Planning
    Site Contract And Budgeting
  • QC, Compliance & Auditing in Clinical Research21 CRF Part 11
    Site Auditing
    Sponsor Compliance And Auditing
    SOP For Clinical Research
  • Clinical MonitoringCRF Review & Source Data Verification
    Drug Safety Reporting
    Drug Accountability Work
    Routine Site Monitoring
    Site Close Out Visit
PHARMACOVIGILANCE
  • Introduction of PharmacovigilanceOverview Of Pharmacovigilance
    Standard Terms And Terminology In Pharmacovigilance
  • Medical Evaluation Of Adverse Events In PharmacovigilanceAdverse Event Reporting System And Form
    Diagnosis And Managements Of ADRs
    Medical Evaluation Of AE
  • Case ProcessingGlobal Perspective Of Pharmacovigilance
    Single Case Processing
    Case Narrative Writing
  • Pharmacovigilance Reporting Database , Signal Detection , Managements And Risk Assessments & EvaluationQuality System In PV
    Expedited Reporting Criteria
    PSUR & PBRER
    PV Database And Signal Detection
    Risk Assessments & Managements
  • Medical Dictionary For Regulatory Activities medDRAmedDRA
  • PV laws And GuidelineRegulatory Guideline & Laws In PV
    SOPS In PV
    PV Auditing And Inspection
    Regulatory Aspects In PV
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