Teleconferences
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View a list of available Audio CDs of previous teleconferences
Spotlight on SOPs
Standard Operating Procedures play a vital role in your FDA compliance activities. Learn more about them with CDs of these popular teleconferences, presented by Dr. Joshua Sharlin.
Automated Tools For Detecting Fraud In FDA Submissions
Presented by Dr. Joshua Sharlin
Monday May 19, 2008, 1:00 pm to 2:30 pm EDT (GMT -4)
OR
Wednesday May 21, 2008, 10:30 am to 12:00 pm EDT (GMT-4)
Any time you collect data, there’s a possibility for fraud: preclinical and clinical trials, even post-marketing studies may include altered or imaginary data. In practice, it’s happened just often enough to alert FDA reviewers that fraud in submissions is a persistent problem.
Fraud creates negative publicity about your company and can put your product approval and even company survival at risk. How are you defending yourself and your firm? Are you taking all the necessary steps and employing all reasonable tools to detect and deter fraud? If you’re interested in exploring paths you can take to insure the integrity of your data, you’ll want to attend this ninety-minute teleconference. Presented by FOI Services and Dr. Joshua Sharlin, the presentation will describe simple techniques and tools you can use to create software programs that can identify fraud that might otherwise go undetected.
This all-new teleconference is intended for an audience with little or no background in statistics or programming and will be offered twice--choose the time most convenient for you and your group:
Monday, May 19 from 1:00 – 2:30 pm EDT –OR-
Wednesday, May 21 from 10:30 am – noon EDT
The session is based on methods Dr. Sharlin developed while working as an FDA reviewer to investigate and detect potential problems in submission data – and these techniques and ideas can be used on any type of FDA submission.
More Information
The Care & Feeding of Your IND
Presented by Michael Hamrell, PhD, Tuesday, May 20, 2008; 1:00 – 2:30 pm EDT
For any new human drug trial destined for FDA review, an Investigational New Drug (IND) application is required before the clinical trial begins. But once your application is submitted and studies begin your responsibilities continue. An IND requires continuous maintenance and updating, incorporating new information, new protocols, and annual reports. Make sure you’re confident of what it takes to maintain your regulatory compliance while your trials are underway. On Tuesday, May 20 beginning at 1:00 pm EDT, join FOI Services and Dr. Michael Hamrell for a 90-minute teleconference designed to cover the requirements for the submission of the initial IND as well as the range of subsequent submissions necessary to keep your file updated and current.