Webinars and Virtual Workshops

Webinars and Virtual Workshops

Postmarketing Drug Safety Compliance: 2019 Inspection Findings This webinar provides an overview of the PADE Compliance Program, as well as discusses inspection findings and trends from PADE inspections completed in Fiscal Year 2019 (October 1, 2018 to September 30, 2019). Date: April 29, 2020 Time: 1:00 PM - 2:00 PM ET  To register for this webinar, please access the details below

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SBIA Webinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency To provide timely guidance to support continuity and response efforts to this public health emergency, FDA published Guidance on Conducting Clinical Trials of Medical Products during the COVID-19 Public Health Emergency. Although the necessity for, and the impact of, COVID-19 control measures on trials will vary depending on various factors, the guidance provides general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity. Date: April 30, 2020 Time: 1:00 PM - 1:45 PM ET To register for this webinar, please access the details below

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Fiscal Year (FY) 2020 Generic Drug User Fee Amendments (GDUFA) Regulatory Science Initiatives Virtual Public Workshop FDA will hold a science-focused Public Workshop to provide an overview of the status of the current FY 2020 Generic Drug User Fee Amendments (GDUFA) Science and Research Priorities as well as solicit input on the development of next year’s (FY 2021) priorities. Date: May 4, 2020 Time: 8:30 AM - 4:30 PM ET For more details about this workshop, please visit the meeting page

Workshop Details