About Jarilyn Dupont
Jarilyn Dupont has been with FDA since 1996 and is currently in the Office of Policy as Director of Regulatory Policy. She has worked in the Office of Legislation in a supervisory capacity and was detailed to in the Office of Chief Counsel as a staff attorney and the Office of Crisis Management as Acting Director. Previous legal experience includes Counsel for the House Judiciary Subcommittee on Intellectual Property and Judicial Administration and Legislative Counsel/Analyst for a House Member. She has experience in private practice, state and local legislative and administrative experience, and non-profit legal services organizations.
The Food and Drug Administration issued a new consent form requirement for certain FDA-regulated clinical trials effective this March 7, 2012. Consent forms of drugs, biological products or devices that are subject to FDA regulation are required to contain a specific statement provided by the FDA. The statement is required for applicable clinical trials initiated on or after March 7, 2012, the statement is intended to advise the participants that clinical trial information may be available on the ClinicalTrials.gov database. The question now is how should the industry comply in a cost effective manner that does not compromise the integrity of the science.
The Knowledge Group has assembled a panel of key thought leaders and regulators to help health executives understand all the important issues with respect to this important topic.
This live webcast is a must attend for all health executives who need to be in the know with respect to FDA's new consent form requirement. The panel will address the key issues and will answer the following main concerns:
- The Applicable Clinical Trial - What are those trials and how to identify an applicable clinical trial?
- What clinical trials are specifically excluded from the definition of “applicable clinical trials?”
- Do sponsors and/or investigators need to obtain approval for informed consent documents with the new statement - Why and How?
- Can the new requirements be waived? In what specific situations?
- Do informed consent documents for studies conducted outside of the United States have to comply with the new regulations?
- What new responsibilities of an IRB will be faced under the new rule?
About The Knowledge Group, LLC/The Knowledge Congress Live Webcast Series
The Knowledge Congress is a series of live webcasts produced by The Knowledge Group, LLC, which examine trends, regulatory, and technology changes across a variety of industries. Its mission is to produce unbiased, objective, and educational live webcasts that examine industry trends and regulatory changes from a variety of different perspectives. The goal is to deliver a unique multilevel analysis of an important issue affecting business in a highly focused format.
The organization brings together the world's leading authorities and industry participants through informative two-hour webcasts to study the impact of changes and emerging trends. Hear from leading government officials/regulators, key thought leaders, and industry experts objectively analyze the latest trends and issues and their impact on industries. For further details, please visit the organization’