Best Practices for Pharmacovigilance Systems

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Then the critical question to ask is how do you go about achieving this? This course is designed to provide you hands on learning on how to manage and conduct drug safety monitoring, perform post-market Pharmacovigilance, detect drug safety signals, improve drug safety or create new products & services and assess, manage and mitigate risks. World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems”. In this course you shall learn the approaches and techniques to enhance drug safety and patient outcomes by leveraging Adverse drug reaction reporting systems, post-market Drug safety intelligence and learn the approaches on how to collect, track, analyze Adverse Drug Reactions (ADR’s), Individual Case Safety Reports (ICSR’s) and how to prevent, reduce or eliminate medications errors.

Date: Thursday, February 18, 2016
Time: 10:00am-11:30 am PST, Online Training
Duration: 90 Minutes
Price: $299 – Includes infographics handouts

Upon completion of this course, you  would  learn:

  • Objectives of Pharmacovigilance
  • What are the best practices of Pharmacovigilance?
  • Understanding the key deliverables of Pharmacovigilance
  • Need of Risk Assessment and Risk Management System
  • Continuous Drug Safety Monitoring
  • Individual Case Safety Reports
  • Adverse Drug Reactions
  • Identifying Product-Event Combinations
  • Premarketing Risk Assessment
  • Postmarket Risk Assessment
  • Identifying and Detecting Safety signals
  • Improving Drug Quality

 

Who Should Attend?

This course is tailored for Pharmacovigilance teams, Drug Safety experts, Risk Mitigation Strategy teams, R&D Scientists, Pharmacokinetics Scientists, Pharmacodynamics Scientists, Drug Safety Monitoring experts, Medical Affairs, Regulatory Authority teams, Clinicians, Academic staff, clinical research, medical writing, medical information personnel.

 

Meet your instructor

Kameshwar Eranki is CEO of VajraSoft Inc., a Intellectual Property Management Software company based in Silicon Valley, California. Kameshwar  is an architect of several award winning Cloud, big data and innovations applications, and drives the growth of Products and Customer portfolio. He has over 22 years experience and is responsible for spearheading Intellectual Property Management Software development, process improvement,biotech &  pharmaceutical industry knowledge,  technology adoption and delivering customer value. He is recognized leader in Big Data Analytics, Cloud Computing and as global Intellectual Property expert.