Clinical Research and Pharmacovigilance Syllabus
CLINICAL RESEARCH & PHARMACOVIGILANCE
Global Institute of Health Science is a pioneer in health science education especially in distance & online education. Global Institute of Health Science is an ISO 21001:2018 Certified health science Institute & globally acclaimed, also certified with copyright approval from IPR Government of INDIA. GIHS have international certification from UASL UK for Quality Control Management System.
WHY CHOOSE US
- BRINGING EXCELLENCE TO HEALTH PROFESSIONALS
- 10+ YEARS OF EXPERIENCE WITH INTERNATIONAL EXPOSURE
- INTERNATIONAL ACLAIMED WITH ISO & GOVT APPROVED
- LIFETIME FREE PERSONALIZED TUTORING FOR SUCCESS
GHIS Clinical Research and Pharmacovigilance courses online program is designed to provide total overview and skill globally in the field of clinical research.
It would help professionals to upgrade & develop their knowledge about ICH GCP Guidelines, regulatory issues and other major aspects of clinical research & trial management.
It is designed to provide total overview and skill globally in the field of clinical research, and pharmacovigilance.
It would help professionals to upgrade & develop their knowledge about clinical trials, data management, pharmacovigilance, regulatory issues and other major aspects of pharmacovigilance. to understand the key concepts in the responsible conduct of research and that conforms to the highest standards for the protection of human research subjects. It can be able to critically appraise the medical scientific literature, including the methodology of published and proposed investigations.
SYLLABUS
- Introduction 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 Research
- Ethics Committees and Institutional Review Board
- Responsibilities of Sponsor / Responsibilities of Investigator
- Responsibilities of Sponsor – Investigator / Responsibilities of Sponsor – Vendor
- Clinical Trial Design and Project Managements
- Clinical Trial Design / Vendor Selection and Managements
- Project Planning / Project Managements
- Principles of good clinical practices
- Protocol Design / CRF Design
- Essential documents in clinical research and regulatory requirements
- Essential Documents / IND Application
- Clinical Study Report / NDA Application
- Informed Consent Process and Documentation
- Study setup process
- Site Selection and Pre- Study Visits
- Site Initiation / Subject Recruitment and Retention Planning
- Site Contract and Budgeting
- QC, Compliance & Auditing in Clinical Research
- 21 CRF Part 11 / Site Auditing
- Sponsor Compliance and Auditing / SOP for Clinical Research
- Clinical Monitoring
- CRF Review & Source Data Verification
- Drug Safety Reporting / Drug Accountability Work
- Routine Site Monitoring / Site Close Out Visit
- PHARMACOVIGILANCE
- Introduction of Pharmacovigilance
- Overview of Pharmacovigilance
- Standard Terms and Terminology in Pharmacovigilance
- Medical Evaluation of Adverse Events in Pharmacovigilance
- Adverse Event Reporting System and Form / Diagnosis and Managements of ADRs / Medical Evaluation of AE
- Case Processing
- Global Perspective of Pharmacovigilance
- Single Case Processing / Case Narrative Writing
- Pharmacovigilance Reporting Database, Signal Detection, Managements and Risk Assessments & Evaluation
- Quality System in PV / Expedited Reporting Criteria
- PSUR & PBRER / PV Database and Signal Detection
- Risk Assessments & Management
- Medical Dictionary for Regulatory Activities medDRA
- medDRA
- PV laws and Guideline
- Regulatory Guideline @ Laws in PV / SOPS in PV
- PV Auditing And Inspection / Regulatory Aspects In PV
Career Options
Pharmacovigilance Associate
Drug safety specialist
Clinical Research Associate
Clinical Research Coordinator
Fees, Payment & Program Duration
Certificate Program
- Duration : 3 Months
- Foundation-level program
- Core concept learning
- Industry awareness focus
- Expert-designed syllabus
- Research-based curriculum
- Academic & tech support
- Skill development course
- Govt-recognized program
- Global accreditation & recognition
- Globally ISO certified
- ₹22,000 For Indian Candidates
- $450 USD For International Candidates
Post Graduate Diploma Program
- Duration : 1 Year
- Advanced-level professional course
- Comprehensive concept mastery
- Research-based modules
- Lifetime expert support
- Job & career assistance
- Free Career Boost (www.TopCVCoach.com)
- High employment potential
- Govt-recognized program
- Global accreditation & recognition
- Globally ISO certified
- ₹32,000 For Indian Candidates
- $699 USD For International Candidates
Fast Track PG Diploma Program
- Duration : 4 Months
- Accelerated PG-level program
- Flexible learning format
- Self-paced completion
- Research-driven curriculum
- Job-oriented training
- Free Career Boost (www.TopCVCoach.com)
- High employability scope
- Govt-recognized program
- Global accreditation & recognition
- Globally ISO certified
- ₹36,000 For Indian Candidates
- $750 USD For International Candidates
- Cheque / Demand Draft / Cash in the name of “Global Institute of Health Science”
- Online Transfer through NEFT or RTGS
- Fee can also be deposited in GIHS bank account
- 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.
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