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.
- +$100 for nonmembers
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