How To Work With The US FDA When You Cant Meet With Them - PowerPoint PPT Presentation

How To Work With The US FDA When You Can’t Meet With Them Experiences and Best Practices for One-on-One Sponsor Meetings and Advisory Committee Sessions

Speakers Moderator Panelists David Arthur Jim DiBiasi Nancy Myers CEO Founding President Partner Salarius Catalyst Pharmaceuticals 3D Healthcare Communications Consulting, Inc Khushboo Matthew Sharma Weinberg Derrick Gingery Deputy CEO Director for Senior Writer, Pink Sheet The Weinberg Operations Group Pharma Intelligence Office of New Drugs (OND), FDA informa | Pharma Intelligence 2

COVID-19 Lockdown Paused In-Person Meetings • Most FDA staff now working at home • Most forced to use video conferencing or teleconferencing software for live communication with each other and sponsors • That means meetings can be very different informa | Pharma Intelligence 3

What Are Sponsors To Do? • We’ve already seen some examples of virtual public meetings and best practices are beginning to emerge • Some common problems also seem to be evident informa | Pharma Intelligence 4

General Points For Discussion Understanding the virtual environment New issues/decisions for the virtual environment Handling and avoiding technical difficulties Making sure your meetings are productive informa | Pharma Intelligence 5

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