CR015 Legislations, Ethics and Good Pharmacovigilance Practices (GVP)

This course is designed to introduce international regulations and guidelines to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs, including biological drug products and specifically guidance on safety signal identification, pharmacoepidemiologic assessment and safety signal interpretation and pharmacovigilance plan development.

The entire Good Pharmacovigilance practices from ICH guidelines will be covered and students will be ready to be exposed to practices of Pharmacovigilance in the pharmaceutical industry.

This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Clinical Research, Drug Safety, and Pharmacovigilance.