Month Flat Week Day

Duke SOM: Investigational New Drug Workshop

Fri. 5 Mar, 2021 9:00 am - 11:00 am

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

Register

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

TraCS Professional Development Seminar: Fostering Inclusion

Fri. 5 Mar, 2021 12:00 pm - 2:00 pm

The TraCS Professional Development Seminar series is intended for research professionals, graduate students, postdocs and early stage faculty researchers. It covers foundational skills useful for career development in clinical/translational research.

The third module of this series is titled Mentor-Mentee Training. Developing and strengthening the mentor-mentee relationship is key to the education and training of future generations of research personnel.

Each session of the seminar will meet Fridays at 12:00 pm. This session is titled: Fostering Inclusion.

Presenter
Susan Pusek, DRSc, Director, Education Programs
NC TraCS Institute

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UNC SWAC & SPAG: Animating Biology

Fri. 5 Mar, 2021 12:00 pm - 1:00 pm

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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Rethinking Clinical Trials Grand Rounds: The Challenges of DSMBs for COVID-19 Trials

Fri. 5 Mar, 2021 1:00 pm - 2:00 pm

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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