Past ReGARDD Sponsored Events

Throughout the year we offer a variety of workshops, presentations and forums given by the regulatory affairs experts from the ReGARDD Program Forum members as well as from guest speakers from across the regulatory industry. You can view past events by clicking on any of the links below:

The Impact of COVID-19 on regulatory strategy and clinical trials

  • Implications of COVID-19 on drug regulatory approvals and inspection processes
    Michael Hinckle, JDK&L Gates
  • The Impact of COVID-19 on the FDA
    David Rothkopf, MSME, MBA, President of MEDicept Inc
  • Bioethics and human trials during the Covid-19 epidemic
    Derry Ridgway, MD, JD
  • The NHLBI-CONNECTS program and the challenges of running COVID clinical studies
    Antonello Punturieri, MD, PhD Scientific Program Director, NHLBI

Why Have a Contract at All?

  • Presentation by Mitch Yelverton, JD, Ashley Richardson, PhD, JD, Mandy Kelley, JD
    Duke University
    Office of Research Contracts
  • Presentation Slides

Intellectual Property Related to Drug and Device Development

  • Presentation by Scott Davis, PhD, Patent Agent
    Director, Technology and Commercialization
    MUSC Foundation for Research Development
  • Presentation Slides

Navigating the Regulatory Pathway for Gene Therapy: Overcoming the Challenges in Development

  • Presentation by Scott R. Burger, MD

Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator INDs and IDEs Workshops

Developing Monitoring Plans for Investigator-Initiated Clinical Trials Presentation

  • Presenter: Sandra "Sam" Sather, MS, BSN, CCRC, CCRA, Co-founder and Vice President of Clinical Pathways, LLC, located in Chapel Hill, NC.
  • November 14, 2017, 11:00 AM - 12:00 PM
    Duke Albert Eye Research Institute Auditorium