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

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how to work with the us fda when you can t meet with them
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How To Work With The US FDA When You Cant Meet With Them - - PowerPoint PPT Presentation

Apr 06, 2023 242 likes •322 views

How To Work With The US FDA When You Cant 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

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Experiences and Best Practices for One-on-One Sponsor Meetings and Advisory Committee Sessions

How To Work With The US FDA When You Can’t Meet With Them

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informa | Pharma Intelligence

Speakers

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Derrick Gingery Senior Writer, Pink Sheet Pharma Intelligence

Jim DiBiasi Founding Partner 3D Communications Matthew Weinberg CEO The Weinberg Group David Arthur CEO Salarius Pharmaceuticals

Moderator Panelists

Khushboo Sharma Deputy Director for Operations Office of New Drugs (OND), FDA Nancy Myers President Catalyst Healthcare Consulting, Inc

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informa | Pharma Intelligence

COVID-19 Lockdown Paused In-Person Meetings

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  • 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

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informa | Pharma Intelligence

What Are Sponsors To Do?

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  • 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
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informa | Pharma Intelligence

General Points For Discussion

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Understanding the virtual environment New issues/decisions for the virtual environment Handling and avoiding technical difficulties Making sure your meetings are productive

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Questions?

Thank you