Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.

This class is to understand basics of pharmacovigilance and to learn about the guidelines followed in various aspects of pharmacovigilance program. 

This course will give me inshort idea about

Pharmacovigilance: basic understanding

GVP module: Types and inshort explaination

Different regulatory bodies and their requirements. 

ICSR case processing and how to identify them. 

PSUR, DSUR basics 

after this course students will be able to understand the basics of pharmacovigilance and why it is important in every pharmaceutical industry 

 Core Capabilities: Pharmacovigilance delivers four primary capabilities to pharmaceutical companies: • Adverse Event Case Management including expedited reporting; • Aggregate Reporting; • Signal Intelligence; and • Risk Management.

These regulations are mandatory to be followed by all pharmaceutical companies