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Advanced Diploma in Clinical Research & Pharmacovigilance

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Last updated: Nov 07, 2025
Level Expert
Language English
Enrolments No enrolled students
Views 42

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

  • Clinical trial regulations & ethics
  • Pharmacovigilance systems & safety databases
  • Case processing & ICSR reporting
  • Signal detection & risk management
  • Regulatory requirements in drug safety

Course Curriculum

1 Topic
6 Lessons
total length

  • Week 1 – Introduction to Clinical Research

    read

    Phases of clinical trials & ethical considerations GCP and regulatory compliance

  • Week 2 – Fundamentals of Pharmacovigilance

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    Drug safety concepts & ADR classifications Role of WHO and regulatory bodies

  • Week 3 – Pharmacovigilance Systems

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    Safety databases & case processing Individual Case Safety Reports (ICSRs)

  • Week 4 – Signal Detection & Risk Management

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    Signal detection methods Risk-benefit analysis in drug safety

  • Week 5 – Regulatory Requirements in Pharmacovigilance

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    Global regulations (FDA, EMA, CDSCO) Post-marketing surveillance

  • Week 6 – Final Project & Evaluation

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    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.

$ 176.40
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Course Includes:

  • 1 Topic
  • 6 Lessons
  • 6 Articles
Sai C

Sai Chaitanya
Verified
India

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Hello! 👋, we are dedicated to delivering academic excellence and professional growth in the fields of Information Technology (IT) and Clinical Research. Our mission is to create a learning environment that blends technical knowledge, research innovation, and industry relevance to prepare learners for global career success.