This training is designed to provide participants with a foundation in regulations, FDA guidances, and risk-based principles aimed at ensuring safety of marketed drug and biological products. The training will include regulatory approaches to prevent medication errors, and the application of regulations and guidances to design labels and labeling to prevent medication errors. FDA will also discuss advances in approaches, tools, and technologies for medication error prevention, pharmacovigilance, and risk management.
| The agenda may be updated. The current version is version 5, updated on June 3, 2020. | The speaker biographies document was updated on June 8, 2020. |
ZIP of Day One Session Slides | ZIP of Day Two Session Slides |
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