FDAnews Announces — 15th Annual FDA Inspections vSummit, Nov. 17-18, 2020

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15th Annual FDA Inspections vSummit
An FDAnews Virtual Conference
Tuesday, Nov. 17-Wednesday, Nov. 18, 2020
https://www.centerwatch.com/fdainspectionssummit

Clinical trial sponsors and sites: Come to the 15th Annual FDA Inspections Summit for insight from current and former FDA officials and industry experts about what needs to be done to be fully inspection ready.

The world of inspections is drastically different than it was before the global health pandemic. Whether this is the new normal or a temporary shift, sponsors and sites need to be ready.

During the 15th Annual FDA Inspections vSummit on Nov. 17 and 18, attendees will gain insights from industry experts on the topics that matter to you. With a track specifically dedicated to clinical trial issues, the vSummit will help one better understand unfamiliar situations brought on by the COVID-19 crisis, such as which tools will best suit a study, how to mitigate risks and ways to appropriately document consent when running a remote trial.

Spend two days with current and former FDA officials and industry experts going through everything one needs to know to navigate the complicated world of clinical trial inspections.

On the first day keynote speaker, Elizabeth Miller, Pharm.D. — Assistant Commissioner Medical Products & Tobacco Operation Office of Regulatory Affairs, FDA — will discuss the FDA’s perspectives on inspections and what to expect now and in 2021.

During the clinical track breakout, get an overview of the telemedicine innovations that can support a study’s success during the pandemic, discover ways to improve trial quality and devise an effective risk-based trial approach.

On the second day, Nov. 18, attendees will hear about the best and worst practices FDA investigators have seen during inspections and determine the steps a team can take to ensure a smooth experience. The panel — full of former FDA officials — includes:

  • David Elder, Executive Vice President Greenleaf Health, former principal

advisor to the FDA’s Associate Commissioner of Regulatory Affairs

  • David Chesney, Principal and General Manager DL Chesney Consulting, LLC,

former District Director in San Francisco, managing all FDA operations in
Northern California, Nevada and Hawaii

  • Vicky Stoakes, President, IntegRx, Inc, former CDRH Chemist, ACNA and

Investigator, Atlanta District Office Drug Cadre

  • Steve Niedelman, Lead Quality Systems and Compliance Consultant, King &

Spalding LLP, former FDA Deputy Associate Commissioner for Regulatory
Operations (moderator)

Attendees will then turn to strategies one can employ to master remote audits and procedures that will help one’s team ensure adequate informed consent in a virtual environment.

Understanding the intricacies of an inspection is critical for any clinical trial team’s success. By joining other clinical trial professionals for this focused track one will be prepared for the next inspection.

Multi-attendee discounts available!
Significant tuition discounts are available for teams of two or more from the same company.

Conference Details
15th Annual FDA Inspections vSummit
An FDAnews Virtual Conference
Tuesday, Nov. 17-Wednesday, Nov. 18, 2020
https://www.centerwatch.com/fdainspectionssummit

Tuition:
vSummit Pricing: $697
Significant team discounts are available.

Easy Ways to Register
Online: https://www.centerwatch.com/fdainspectionssummit
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

About CenterWatch:
Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.

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