Advanced Diploma in Clinical Research & Pharmacovigilance
About This Course
This course equips you with in-depth knowledge of clinical research along with drug safety monitoring, ADR reporting, and regulatory pharmacovigilance practices.Outcome: Prepare for careers as a Drug Safety Associate, Pharmacovigilance Officer, or Safety Data Analyst.
What you'll learn
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Clinical trial regulations & ethics
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Pharmacovigilance systems & safety databases
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Case processing & ICSR reporting
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Signal detection & risk management
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Regulatory requirements in drug safety
Course Curriculum
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Week 1 – Introduction to Clinical Research
read- Phases of clinical trials & ethical considerations
- GCP and regulatory compliance
Week 2 – Fundamentals of Pharmacovigilance
read- Drug safety concepts & ADR classifications
- Role of WHO and regulatory bodies
Week 3 – Pharmacovigilance Systems
read- Safety databases & case processing
- Individual Case Safety Reports (ICSRs)
Week 4 – Signal Detection & Risk Management
read- Signal detection methods
- Risk-benefit analysis in drug safety
Week 5 – Regulatory Requirements in Pharmacovigilance
read- Global regulations (FDA, EMA, CDSCO)
- Post-marketing surveillance
Week 6 – Final Project & Evaluation
read- Case study analysis on drug safety
- Viva & placement preparation
Prerequisites
M.B.B.S / B.D.S / B.A.M.S / B.H.M.S.
B. Pharmacy / M.Pharmacy / B.M.L.T
BSc in M.L.T / B.P.T / BSc in Nursing.
BSc and MSc in Biotechnology, Microbiology, Genetics
B.E (Biotechnology) / B.tech (Biotechnology).
Biochemistry ,Botany , Zoology ,Statistics or life sciences.
Course Includes:
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1 Topic
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6 Lessons
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6 Articles
