Charlotte AHEC and the UNC Department of Medicine will present the 45th Annual Internal Medicine Conference on March 10-12, 2021 offered virtually from the William and Ida Friday Center for Continuing Education.

The conference features cutting-edge, evidence-based updates on common medical conditions managed by primary care clinicians, including SARS-CoV-2 updates designed for internists, family physicians, generalists, advanced practice providers and other health care providers working in an adult primary care setting.

Atrium Health designates this Live Webinar Activity for a maximum of 24.5 AMA PRA Category 1 Credit(s)TM.

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Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator Investigational Device Exemptions (IDEs)

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

This workshop will:

• Discuss FDA’s approach to regulation of devices in clinical studies and for marketing
• Provide guidance on when the IDE regulations apply and discuss possible exemptions
• Review significant risk and non-significant risk device studies
• Discuss the preparation, submission, and maintenance of IDE applications
• Review case scenarios

Presenters

Alysa Vereen, PharmD, Regulatory Affairs Scientist, Duke University School of Medicine
David Jensen, PhD, RAC, 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: IND workshop Mar 5

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 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: Articulating your Mentoring Philosophy.

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

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Lessons Learned from the Gates MRI Virtual COVID-19 Trial

This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features Mohamed Bassyouni, PharmD and Jintanat Ananworanich, MD, PhD of the Bill and Melinda Gates Medical Research Institute.

Presenters
Mohamed Bassyouni, PharmD, Product Development Program Leader
Bill and Melinda Gates Medical Research Institute

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