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BioCommunique Article

Learn how to overcome challenges brought on by COVID-19 from clinical trial delays to regulatory reviews as you hear from experts at FDA.

Clinical Trials in the Era of COVID-19: Insights from the FDA Webinar – August 11

  • 2020-07-23T19:00:00.000+0000
  • California
  • Author: Brittany Blocker

Biocom, in partnership with the Food & Drug Administration (FDA), is hosting a webinar on conducting clinical trials during the ongoing COVID-19 pandemic. Join us as we receive insight from:

  • Jacqueline Corrigan-Curay JD, MD, Director, Office of Medical Policy (OMP)
  • James Smith, MD, Deputy Director, Office of New Drugs (OND), Division Clinical Policy
  • Paul Kluetz, MD, Deputy Director, Oncology Center of Excellence (OCE)

The pandemic has disrupted the operations of many biotechnology and pharmaceutical companies. The life science industry is searching for clarity and strategies on how to address the challenges presented by the COVID-19 outbreak. The pandemic has forced many companies to make difficult decisions to pause ongoing trials and reconsider timelines for data readouts, regulatory reviews, and product launches due to impaired access to the healthcare system, travel restrictions, patient willingness to participate in trials and shifts in resources to fight the pandemic.

This webinar will address members’ concerns on the impact of COVID-19 in the following areas:

  • Inform Consent Forms (ICFs)
  • Protocol Deviations
  • Benefit/Risk Assessments
  • Adverse Events Reporting
  • Clinical Study Reports (CSRs)
  • Compassionate Treatments
  • Emergency Approvals
  • Cancer Screenings

*Please note that there will not be a Q&A. We have submitted questions in advance to the speakers.