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

Frequently Asked Questions

What is clinical research and pharmacovigilance?

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.

Is pharmacovigilance a good career?

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

Who is eligible for a pharmacovigilance course?

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

Is pharmacovigilance better than medical coding?

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.

Is pharmacovigilance in demand?

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

Syllabus – Clinical Research and Pharmacovigilance

Syllabus – Clinical Research and Pharmacovigilance

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