Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator Investigational New Drugs (INDs)

The Duke University School of Medicine Office of Regulatory Affairs and Quality is conducting an IND Workshop co-sponsored by the Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD).

This workshop will:

• Define an investigational drug, including off-label use of FDA approved drugs
• Provide guidance on determining when the IND regulations apply to research studies
• Discuss the preparation and submission of IND applications to FDA
• Review maintenance and safety reporting requirements
• Review case scenarios

Presenters

Rachel Johnson, PhD, RAC, Regulatory Affairs Scientist, Duke University School of Medicine
Katherine Deland, PhD, Regulatory Affairs Scientist, Duke University School of Medicine

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NC TraCS Regulatory Support is available to provide guidance and assistance with IND and IDE submissions and understanding the regulatory requirements for Federally-regulated studies. UNC Investigators and study teams with questions about regulatory submissions and pathways can submit a request to speak with an expert.

See also: IDE workshop Mar 12

Are you interested in improving how you communicate your science? Janet Iwasa will present her work on science animation, graphics, and tools in this seminar.

This event is co-sponsored by the UNC Science Policy Advocacy Group and the UNC Science Writing and Communication Club as part of their 2021 Spring Communication Series.

Presenter
Janet Iwasa, PhD, Assistant Professor of Biochemistry
University of Utah

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Data and Safety Monitoring Boards for Trials of COVID-19 Treatments and Vaccines: The Challenges

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features Susan S. Ellenberg, PhD. Ellenberg is a Professor of Biostatistics, Medical Ethics, and Health Policy at the University of Pennsylvania.

Presenter
Susan S. Ellenberg, PhD, Professor of Biostatistics, Medical Ethics, and Health Policy
University of Pennsylvania

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