Regulatory Approval Primer

- Level: Beginner
- CPE: 1.0 Credits
- Time: 60 Minutes
Evaluate development risk, timelines, and investment opportunities by understanding the complex path from IND to NDA/BLA with Regulatory Approval Primer. Uncover the impact of key regulatory timelines, agency interactions, and fast-track strategies that accelerate approval of life-saving therapies.
- Learn the purpose and timing of FDA formal meetings
- Gain insight into the tools regulators use to interact with the industry and the purpose of each
- Understand the difference between FDA designations designed to accelerate the approval process
- Best Value: Unlimited Learning
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Get full access to this course with a one time purchase.
- 1-month access to all course material
- CPE credits included
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- Self-paced and on-demand
- Ideal for focused, one-off learning
- Overview
- Agenda
- Features
- Justify This Training
- FAQ
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Agenda
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Introduction to the Regulatory Process
Describes the organization and mission of the FDA and EMA and the global harmonization of drug testing requirements.
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IND/CTA Filing
Explains the components and timing for filing an Investigational New Drug (IND) application with the FDA and a Clinical Trial Application (CTA) with the EMA.
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User Free Programs
Outlines the responsibilities of regulatory authorities toward drug manufacturers that pay designated fees, as defined by the Prescription Drug User Fee Act (PDUFA) in the United States and the European Union’s regulatory fee framework.
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Orphan Drugs and Expedited Pathways
Lists various FDA and EMA expedited approval pathways available to drug companies, including orphan drug designation.
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Market Approval
Describes the process of filing a New Drug Application (NDA) or Biologics License Application (BLA) in the US and a Marketing Authorization Application (MAA) in the EU for market approval. The Generics and biosimilar approval pathways are also showcased.
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
Justify This Training
View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.
FAQ
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