Flagship Academic Pharmacovigilance M.Pharm Syllabus Paid Access

Clinical Research and Pharmacovigilance

By Dr. Saurabh Saklani, Dr. Sunita Kumari, Shalini Sharma & Dr. Bhanu Prakash Rahi

Clinical Research and Pharmacovigilance sits at the meeting point of two disciplines that a modern pharmacist must command: the design and conduct of the clinical trials that generate a medicine's evidence, and the science of pharmacovigilance that keeps watch over that medicine for as long as it is used. This textbook follows the prescribed MPL 204T syllabus unit by unit, and each chapter is written to teach the first-time learner, to serve the reviser, and to prepare the examinee from the same pages.
Category
Pharmacovigilance
Target Audience
M.Pharm II Semester Students
Course Code
MPL204T
Syllabus
M.Pharm (PCI)
ISBN
978-81-903393-3-9
Edition
1st Edition (2026)

About This Book

This textbook has been written to meet the requirements of postgraduate pharmacy students studying Clinical Research and Pharmacovigilance (MPL 204T). It follows the prescribed syllabus unit by unit while telling one continuous story: how the design and conduct of a clinical trial generates a medicine's evidence, and how the science of pharmacovigilance keeps watch over that medicine for as long as it is used.

The treatment is deliberately pointwise. Definitions are stated exactly, classifications are laid out in full, and comparisons are drawn in ruled tables so that the distinctions an examiner tests are visible at a glance. Every chapter opens with its learning outcomes, develops the content through numbered points and original figures, and closes with a graded self-assessment of short-answer questions with model answers, long-answer questions with structured guidance, and multiple-choice questions. The book moves from the regulatory perspectives of clinical trials and ICH-GCP through trial design, documentation, and adverse drug reactions to the basic aspects, terminologies, and establishment of pharmacovigilance.

Keywords

Clinical Research Pharmacovigilance Clinical Trials ICH-GCP Good Clinical Practice Informed Consent Ethics Committee Adverse Drug Reactions ADR Reporting Drug Safety Signal Detection Schedule Y M.Pharm MPL204T

How to Cite

Saklani, S., Kumari, S., Sharma, S., & Rahi, B. P. (2026). Clinical Research and Pharmacovigilance (1st ed.). WiseLeaf Scientific Ventures. ISBN: 978-81-903393-3-9

DOI: 10.66079/wiseleaf.clinical-research-pharmacovigilance-mpl204t.2026

Paid Access — Preview the first 10 pages for free. Full book will be available for purchase through our partner platforms.

Back to Books Catalog

Related WiseLeaf titles