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Learn about FDA regulations and expectations for the content, submission, and review of Investigational New Drug (IND) Products and the importance of regulatory strategy. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.
Course Level: Beginner

What you will learn

  • The fundamentals of the Investigational New Drug Products
  • Preparation
  • Content
  • Strategy
  • Activities and submissions required to maintain an IND
  • Special Regulatory Considerations for Clinical Development

Who should attend?

  • Regulatory affairs professionals new to the IND process
  • Clinical research and development professionals
  • Biostatisticians
  • Basic researchers
  • Quality and manufacturing professionals
  • Medical writers
  • Business professionals
  • Project Managers

Learning objectives

At the conclusion of this activity, participants should be able to:

  • Explain the importance of incorporating regulatory strategy into the drug development plan
  • Describe the Identify FDA review processes for evaluating INDs
  • Plan and prepare an IND, and know the reporting requirements for IND amendments
  • Identify regulatory mechanisms to facilitate development of new therapies