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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Disclaimer: This course details are for the purpose of awareness about the program and career opportunities.

The exact information on course structure may vary from this information.

Frequently Asked Questions

Clinical research involves conducting studies to evaluate the safety and efficacy of new medical treatments, drugs, or devices in human subjects. Pharmacovigilance, on the other hand, focuses on the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

Yes! With the increasing emphasis on drug safety and regulatory compliance, there is a growing demand for professionals in pharmacovigilance.

Individuals with a background in life sciences, pharmacy, medicine, nursing, or related fields are eligible for pharmacovigilance courses.

Pharmacovigilance and medical coding are different fields with distinct roles. Pharmacovigilance focuses on drug safety and adverse event reporting, while medical coding involves assigning codes to medical diagnoses and procedures for billing and record-keeping. The choice depends on individual interests, skills, and career goals.

Yes, due to increased regulatory scrutiny and the need for pharmaceutical companies to ensure the safety of their products, pharmacovigilance is in demand. 

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