Monitoring/ Monitoring Effectiveness

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2023 Agenda

Saturday, September 30, 2023 at 8:30 to 9:15                                                                                         Track: Monitoring / Monitoring Effectiveness

CRA Best Practices

Mr. Chan will discuss best practices gained by a senior CRA with over 20 years of experience. 317
Presenter: Aaron Chan, BA, Principle Clinical Research Associate, PPD part of Thermo Fisher Scientific

Saturday, September 30, 2023 at 9:20 to 10:05                                                                                        Track: Monitoring / Monitoring Effectiveness

Remote Monitoring Challenges During the Midst of a Pandemic

Ms. Mahanti will discuss how the world of clinical trial monitoring faced challenges during this the COVID-19 pandemic. We will learn to do the best with limited resources, yet maintain patient safety! 319
Presenter: Harshini Mahanti, MSc, CCRP, Senior Clinical Research Monitor, University of Miami 

Saturday, September 30, 2023 at 10:50 to 11:35                                                                                  Track: Monitoring / Monitoring Effectiveness

How a CRA Can Support a Study Site Before, During, and After a Regulatory Inspection

It doesn't happen often in a CRA's career, but when it does, it can induce panic like nothing else: the phone call from your site announcing "The FDA is coming on Monday." That is exactly what happened to me one already busy day. After the initial panic (I may or may not have hyperventilated), and with the support of my company's quality department, I put together a plan to effectively prepare my site for the inspection, support the site during the inspection, and guide them in responding to the 483 after the inspection. Saying that my learning curve was steep is an understatement, but the site and I survived and even became stronger because of it. I am here now to share the steps you can take when you get that phone call to cultivate a well-prepared site, a smooth inspection, and a stellar 483 response that results in a stronger site (and makes you a stronger CRA). 321
Presenter: Wendy Upton, AD, BA, RN, Clinical Team Manager, PPD, part of Thermo Fisher Scientific