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Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions
Model Master Files Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions

Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions

Navigating Controlled Correspondences to Support Generic Drug Development
Navigating Controlled Correspondences to Support Generic Drug Development

Navigating Controlled Correspondences to Support Generic Drug Development

Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development
Cell Therapies and Tissue-Based Products: A Public Workshop

Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development

BsUFA III Regulatory Science Pilot Program: Progress Update
BsUFA III Regulatory Science Pilot Program Progress Update

BsUFA III Regulatory Science Pilot Program: Progress Update

FDA Clinical Investigator Training Course (CITC) 2024
FDA Clinical Investigator Training Course (CITC) 2024

FDA Clinical Investigator Training Course (CITC) 2024

M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Implementing the Final Guidance

M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Implementing the Final Guidance

Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation

Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation

Global IDMP Implementation – Getting Closer to the Goal

Global IDMP Implementation – Getting Closer to the Goal

ICH M12 Drug-Drug Interaction Studies Final Guidance

ICH M12 Drug-Drug Interaction Studies Final Guidance

Advancing Generic Drug Development: Translating Science to Approval 2024

Advancing Generic Drug Development: Translating Science to Approval 2024

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