Academic Pharmacovigilance PCI 2026 (NEP 2020) Paid Access

Pharmacovigilance (Theory)

By Dr. Bindumadhuri Kamba, Dr. Pooja Bagdi & Dr. Aiman Sifat

This book is a complete course text for Pharmacovigilance (BP705T), the theory paper of the seventh semester of the Bachelor of Pharmacy programme under the Pharmacy Council of India syllabus. It is written for the student who must both understand the subject and pass the university examination, and it has been kept faithful to the prescribed syllabus throughout. Pharmacovigilance is taught here as one connected system rather than a list of facts. The book follows a single thread: that a medicine's safety is never fully known at the moment of approval, and that an organised, lifelong watch over medicines, built upward from the individual case through coding and causality to signals, regulation, and risk management, is what keeps benefit ahead of risk.
Category
Pharmacovigilance & Drug Safety
Target Audience
B.Pharm VII Semester Students
Course Code
BP705T
Syllabus
New PCI 2026 (NEP 2020)
ISBN
978-81-688547-9-6
Theory Hours
45 Hours (3 hours/week)

About This Book

The Indian frame is kept central throughout, with the Pharmacovigilance Programme of India, the Indian Pharmacopoeia Commission, the Central Drugs Standard Control Organisation, and the national immunisation safety system treated as the working environment an Indian graduate will operate within. This approach ensures students understand not just the global concepts but also the specific regulatory and operational context they will encounter in their professional careers.

The textbook covers all essential topics including the history and evolution of pharmacovigilance, detection and assessment of adverse drug reactions, signal detection and management, drug safety communication, regulatory requirements for drug safety, and the role of various stakeholders in ensuring medication safety. Special emphasis is placed on practical aspects such as causality assessment, benefit-risk evaluation, and preparation of safety reports.

Each chapter is structured to build upon previous knowledge, with clear learning objectives, case studies, and examination-oriented questions. The book includes numerous real-world examples from the Indian pharmaceutical landscape, making the content relevant and immediately applicable for students preparing to enter the workforce.

Keywords

Pharmacovigilance Drug Safety Adverse Drug Reactions Signal Detection Risk Management PvPI CDSCO Indian Pharmacopoeia Causality Assessment Benefit-Risk Evaluation Safety Reports B.Pharm BP705T PCI Syllabus 2026 NEP 2020

How to Cite

Kamba, B., Bagdi, P., & Sifat, A. (2026). Pharmacovigilance (Theory) (1st ed.). WiseLeaf Scientific Ventures. ISBN: 978-81-688547-9-6

DOI: 10.66079/wiseleaf.pharmacovigilance-bp705t.2026

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