Post Approval Requirements for Drugs: An Introduction to Safety Reporting and Post-Approval Changes

Discuss pharmacovigilance and Adverse Drug Experience (ADE) Reporting. Explore FDA’s drug safety review activities. Review Medicare, Medicaid, and reimbursement issues. Learn about the Drug Supply Chain Security Act (DSCSA) product tracing requirements.

Mantej (Nimi) Chhina,  Senior Director and Head, Global Regulatory Policy, BioMarin Pharmaceutical Inc


This session was recorded as part of FDLI’s Virtual Introduction to Drug Law and Regulation Course in April 2020. 

Get Access

  • +$100 for nonmembers


Internet Explorer and Microsoft Edge are not supported by the checkout process.

Please use Chrome, Firefox, or Safari.  If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.

Virtual Learning FAQ

On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.


On-demand content can be played back on most devices.

If you have concerns, please click the Test Your System link to determine your device’s compatibility, as well as system requirements. 

CLE credit is not currently available for pre-recorded sessions.

Related Content