FDAnews and CenterWatch Announce — The 16th Annual FDA Inspections vSummit Nov. 16–17, 2021

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Get expert opinions on clinical trial inspections during this year’s most important inspections summit. Register today.



16th Annual FDA Inspections vSummit
An FDAnews Virtual Summit
Tuesday-Wednesday, Nov. 16-17, 2021

Clinical trials were upended by the COVID-19 pandemic and the FDA was forced to adjust most of their inspection procedures. Will inspections ever go back to the way they were? Will the agency rely more heavily on remote tools going forward? Has your team adapted to the technologies that arose out of the health crisis?

To succeed in clinical trials, one needs to be able to navigate these complicated questions — and one needs to do it effectively and efficiently. Luckily, this year’s 16th Annual FDA Inspections vSummit can help.

The summit’s dedicated clinical trial track includes practical advice from current and former FDA officials, along with other seasoned industry leaders. These tips will bring attendees a deeper understanding of the state of the agency and provide a framework for moving forward. In these virtual, interactive and expert-led sessions, dig deeply into the most relevant and timely inspections conversations in clinical trials.

Here’s some of what one will experience:

  • At the start of this program, one will explore the FDA’s expectations for future inspections with Elizabeth Miller, Pharm.D., Assistant Commissioner Medical Products & Tobacco Operation Office of Regulatory Affairs, FDA.
  • Follow that conversation with discussions about the ways COVID-19 encouraged a more streamlined approach to trial management, current agency policies around remote informed consent and how to best assess risk in recall situations.
  • On the second day, get straightforward details on how to manage an inspection — and what to avoid — from Steve Niedelman, former FDA Deputy Associate Commissioner for Regulatory Operations.
  • Attendees will then consider what inspections will look like in a post-COVID world, how to adequately vet and work with vendors and the significant benefits of artificial intelligence.

There have been tremendous changes to the FDA’s inspections process since the start of the COVID-19 pandemic and there are only more to come. Learn the lessons needed to navigate the ever-changing world of inspections, whether that means a return to on-site inspections or a continued integration of remote processes.

Virtual Workshop Details:
16th Annual FDA Inspections vSummit
An FDAnews Virtual Summit
Tuesday-Wednesday, Nov. 16-17, 2021

Single Attendee - $597.00
Group of 2-4 Attendees (Save 10%) - $527.00
Group of 5-6 Attendees (Save 15%) - $492.00
Group of 7-9 Attendees (Save 20%) - $458.00
Group of 10+ Attendees (Save 25%) - $423.00

Easy Ways to Register:
Online: https://wcg.swoogo.com/fda-inspections-summit
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
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