Pharmacovigilance Made Easy

💊 Pharmacovigilance is pharmacological science relating to detection, assessment and prevention of adverse effects of drugs. Improving drug safety is a task concerning not only regulatory authorities and pharmaceutical industry but also prescribing physicians. This is done right from the drug research and development stage to post marketing drug surveillance.

💊 This book intends to provide you all the information that you need to crack the Pharmacovigilance interview by providing you basic understanding of the concepts such as:

• 👉Introduction, History & Overview of Pharmacovigilance
• 👉Drug Development and Clinical Trial Phases
• 👉Pharmacovigilance Process & Life cycle
• 👉Introduction and responsibilities: USFDA, EMA and CDSCO
• 👉Clinical Development process
• 👉Different phases of clinical Trials
• 👉Adverse events and its types
• 👉Drug Safety in clinical trials and post marketed drugs
• 👉Different sources of Adverse events reporting
• 👉Different types of AE reporting Forms
• 👉Expedited reporting and its timelines
• 👉Different departments working on Pharmacovigilance
• 👉Roles and responsibilities of case receipt unit
• 👉Roles and responsibilities of Triage unit
• 👉Four factors for the reportable case
• 👉Seriousness criteria of adverse event
• 👉Expectedness or Listedness of adverse event
• 👉Causality assessment of the adverse event
• 👉Introduction to safety database and different types
• 👉Narrative writing
• 👉Case quality check, Medical review and its submission.
• 👉PSUR and its submission timelines
• 👉Aggregate reporting Overview
• 👉Signal Management Overview& many more!