Clinical Trial Transparency Is 'Real' Work! An Update on Clinical Trial Registration and Results Disclosure Requirements

Presented by Patricia Teden

Recorded On: Wednesday, June 23, 2010

Duration: 90 minutes

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RECORDING HIGHLIGHTS:

The FDA Amendments Act of 2007 (FDAAA) enacted in September 2007 instituted requirements for the public registration of clinical trials of drugs, biologics and medical devices and for posting of applicable clinical trials results on www.clinicaltrials.gov. FDAAA also left some significant questions unanswered; answers to these open questions are due later this year. The State of Maine overhauled their clinical trial disclosure law in November 2009. More than twenty countries have clinical trial disclosure expectations – some codified in law and others enforced by other mechanisms.

Study sponsors often react with a shake of the head saying ‘I can’t believe what this has turned out to be.” Find out what clinical trial transparency is turning out to be for study sponsors – considerable work!

In this 90 minute audio conference, Patricia Teden, Principal of Teden Consulting LLC,will provide an update on recent ClinicalTrials.gov experiences, regulatory trends concerning clinical trial transparency and challenges for being compliant.

Questions to be Answered:

What is required by FDAMA113, FDAAA and the State of Maine regarding clinical trial disclosure?
What is going on internationally?
How did we get here? Who uses and/or benefits from clinical trial transparency?
What is the effort required of study sponsors to comply with the various laws/expectations?

Attendees Who Will Benefit From This Audio Conference Include:

Clinical quality assurance professionals
Clinical operations and project managers
Clinical research associates and biostatisticians
Trial investigators (especially if also trial sponsors)
Compliance officers and professionals
Technical writers
Policy and procedure developers
GCP trainers

YOUR EXPERT(S):

Patricia Teden
Patricia Teden is the Principal of Teden Consulting LLC, a consultancy specializing in clinical trial disclosure strategy and operations. She has fifteen+ years of experience conducting global clinical trials, pharmacovigilance, alliance management, clinical data management, implementing IT projects and leading change management initiatives for global pharmaceutical companies. Pat is a founding member of the DIA Special Interest Area Community (SIAC) for Clinical Trial Disclosure and a frequent speaker at industry conferences. Patricia has a BA in Biology from Cedar Crest College and an MBA from the Harvard Business School.