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AKTU Pharmacovigilance (Theory) (BP705T) Syllabus PDF – B.Pharm 7th Semester
Pharmacovigilance (Theory) BP705T
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Official AKTU syllabus of Pharmacovigilance (Theory) (BP705T) for B.Pharm 7th Semester – 3 credits, L-T-P 3-0-0. Read the unit-wise course content, course outcomes, evaluation pattern and recommended books online, or download the PDF.
Syllabus — Pharmacovigilance (Theory)
Download PDFBP705T · 3 credits · L-T-P 3-0-0
Course Objectives
- Understand the principles, scope, and importance of pharmacovigilance in ensuring drug safety and patient care.
- Familiarize students with the classification of adverse drug reactions and the methods used for their detection, assessment, monitoring, and prevention within healthcare systems.
- Explain the concepts and significance of immunovigilance in monitoring and managing adverse events following immunization.
- Learn national and international regulatory frameworks, guidelines, and reporting systems related to pharmacovigilance and immunovigilance.
- Analyze pharmacovigilance data and apply risk management strategies to enhance medication and vaccine safety.
Course Outcomes
| CO | Upon successful completion of this course, the students will be able to: |
| No. | |
| 1 | Explain the core concepts, objectives, and significance of pharmacovigilance and immunovigilance. |
| 2 | Interpret and analyze national and global regulatory frameworks related to drug and vaccine safety. |
| 3 | Identify, document, and report ADRs and AEFIs using appropriate pharmacovigilance systems. |
| 4 | Evaluate pharmacovigilance data to detect trends, safety signals, and risk factors associated with medicinal products. |
| 5 | Propose and implement risk management strategies aimed at improving patient safety and public health outcomes. |
Course Content
| Unit | Topics | No. of |
|---|---|---|
| I | Fundamentals of Pharmacovigilance a) Concept, history, and importance of pharmacovigilance b) Basic drug classification systems (introductory overview only): c) ATC classification, ICD ATC system ICD d) Drug-related problems and medication safety e) Drug safety considerations in special populations: Paediatrics Geriatrics Pregnancy and lactation | 10 hour |
| II | Pharmacovigilance Systems and Regulatory Framework a) Objectives and functions of pharmacovigilance b) Methods of pharmacovigilance data collection: Spontaneous reporting Cohort and case-control studies c) Global pharmacovigilance systems: WHO International Drug Monitoring Programme Role of CIOMS and major regulatory agencies (e.g., USFDA, EMA) d) Pharmacovigilance Programme of India (PvPI) e) Establishment and role of ADR Monitoring Centres | 10 hour |
| III | Adverse Drug Reactions (ADRs) a) Classification and types of ADRs b) Mechanisms and risk factors for ADRs c) Methods of ADR monitoring, detection, and reporting d) Assessment of causality, severity, predictability, and preventability of ADRs e) Management of ADRs f) Online reporting mechanisms and databases (WHO-ART, VigiBase, Vigiflow, Oracle Argus, OpenVigil software). g) MEDRA | 8 hour |
| IV | Immunovigilance and Other Disciplines of Pharmacovigilance a) Definition, scope, and significance of immunovigilance, cosmetovigilance, nutraceutical-vigilance, materiovigilance, herbovigilance, ecopharmacovigilance, and hemovigilance b) Vaccination failure and vaccine pharmacovigilance (vaccinovigilance) c) Overview of adverse events following immunization (AEFIs) d) Immunization safety monitoring systems in India | 7 hour |
| V | Risk Communication, Evaluation, Management, and ICH Guidelines a) Risk evaluation and management strategies in pharmacovigilance and immunovigilance | 10 hour |
and immunovigilance
- Communication in drug safety crisis management
- Communication with regulatory agencies, business partners, and healthcare facilities
- Analysis of real-world case studies and lessons learnt
- Emerging trends and challenges in pharmacovigilance and immunovigilance
- Overview of safety data generation
- Objectives of ICH guidelines
- Expedited and aggregate reporting
- Individual Case Safety Reports (ICSRs)
- Periodic Safety Update Reports (PSURs)
- Post-approval expedited reporting
- Good Clinical Practices (GCPs) regulation 2019
- Application of pharmacogenomics and pharmacometrics in pharmacovigilance.
Recommended References
- Andrews, E. B. and Moore, N. Wiley Blackwell.
- Cobert, B. World Scientific Publishing.
- Jose, J., Cox, A. R. and Paudyal, V. Principles and Practice of Pharmacovigilance and Drug Safety. Springer.
- Strom, B. L., Kimmel, S. E. and Hennessy, S. Textbook of Pharmacoepidemiology. Wiley.
- Talbot, J. and Waller, P. Wiley.
- Waller, P. and Harrison-Woolrych, M. An Introduction to Pharmacovigilance. Wiley Blackwell.
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