Course Description




Pharmacovigilance deals with the processes for monitoring and evaluating ADRs and it is a key component to establish that drugs are safe to be used pharmacovigilance is involved mainly to detect adverse drug events that were previously either unknown or poorly understood. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries.


Unique Service Point (USP)




This course is designed to impart the knowledge of regulatory requirements of drug safety monitoring for various countries, train the students on management of Pharmacovigilance projects in an organization

What is Pharmacovigilance?

Pharmacovigilance, as defined by the World Health Organization, is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other possible drug-related problems. Recent inclusions to this definition are: herbals, traditional and complementary medicines, blood products, biological, medical devices and vaccines.

What is the course duration?

Course duration is 6 months.

Who is eligible for this course?

All Graduates are eligible.

Modules
  • Introduction to Pharmacovigilance
  • Drug development process
  • Drug Safety in Clinical Trials and Marketed Drugs
  • Different types of adverse events
  • Sources of Adverse Event Reports
  • Different Types of Adverse event report forms
  • Timelines for reporting adverse events
  • Reportable cases
  • Seriousness criteria
  • Expectedness of Adverse event
  • Causality Assessment of adverse event
  • Narrative writing
  • Case processing
  • Development of PSUR/DSUR
  • Roles and responsibilities of different stakeholders
  • Overview of MedRA and Oracle Argus