Pharmacovigilence in Healthcare

IIHMR University conducted a Management Development Programme on Pharmacovigilence in Healthcare from 15-19 December 2015. It was a Five day program which started on 15 dec 2014 and concluded on 19 dec 2014 at Indian Institute of Health Management and Research University

World Health Organization defines Pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicinerelated problem.

Once drugs are into the market, a medicine leaves the secure and protected scientific environment of clinical trials and is legally set free for consumption by the general population. At this point, most medicines will only have been tested for short-term safety and efficacy on a limited number of carefully selected individuals. Understanding different aspects of Pharmacovigilance is important as it is essential that new and medically still evolving treatments are monitored for their effectiveness and safety under real-life conditions post release.
The aim of the course is to strengthen participants with concepts and current practices in Pharmacovigilance.

OBJECTIVES OF THE PROGRAM

• To understand different aspects of Pharmacovigilance in practice
• To prepare for Pharmacovigilance audit preparation & regulatory inspection
• To understand issues regarding risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug effects (ADEs).
• To understand about detection and monitoring of the ADR.
• To introduce participants to fundamental statistical, compliance and regulations concepts and methods.

KEY CONTENTS

• Adverse event (AE) definition & reporting
• Causality assessment of adverse event
• Risk Management
• Compliance to Clinical Safety
•  Expectedness assessment of an adverse event
• Medical Dictionary, Drug coding, Unbinding & reporting
• Issue work-up of aggregate data-consideration of preclinical, clinical, epidemiological, safety database, aggregate analysis
• Design of Post marketing studies
• Global Pharmacovigilance Regulations, ICH, EMEA, US FDA directives
• Periodic Surveillance Update Report/ Annual Safety Report
• National Pharmacovigilance Program
•  Management and Importance of Pharmacovigilance