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?
Course Level: Intermediate
Method Of Presentation: Group-Based-Internet
Developer: The Knowledge Group, LLC
Recommended CLE/CPE Hours: 1.75 - 2.0
Advance Preparation: Print and review course materials
Course Code: 124329
Course Fee: $299 (Please click here for details)
Agenda (click here to view more)
Jarilyn Dupont , Director of Regulatory Policy,
FDA/Office of Policy
Lisa Murtha, Esq., Partner,
SNR Denton US LLP
Harry Nelson, Co-Founder,
FDA/Office of Policy
Director of Regulatory Policy
speaker bio »»
SNR Denton US LLP
Lisa Murtha, Esq.
speaker bio »»
speaker bio »»
Who Should Attend?
- FDA Attorneys
- Legal Executive
- Health Care Law Attorneys
- Health Industry Advisors
- Health Policy Directors
- Compliance Officers
- State Health Executives/Professionals
- General Counsel
- Senior Management
- Senior Executives
- Professionals coming from Food and Drug Industries
- Consultants & Clients in the Food and Drug Industries
This is a must attend event for food and drug professionals who would like to learn and understand the new consent requirement including its impact to the industry.
- Guidance and best practices regarding reading & interpreting financial statements
- Hear directly from key regulators & thought leaders
- Interact directly with panel during Q&A
Register and be in the know! Enroll in this course today by clicking the “Register” button below. Discounts apply to those who register in advance!
Please note, the event date is firm although it may be subject to change. Please click here for details.
The Knowledge Group, LLC is producing this event for information purposes only. We do not intend to provide or offer business advice. The contents of this event are based upon the opinions of our speakers. The Knowledge Congress does not warrant their accuracy and completeness. The statements made by them are based on their independent opinions and does not necessarily reflect that of The Knowledge Congress' views. In no event shall The Knowledge Congress be liable to any person or business entity for any special, direct, indirect, punitive, incidental or consequential damages as a result of any information gathered from this webcast.
Legal Series: Understanding FDA’s Consent Form Requirements
FDA/Office of Policy
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As a result of our landmark victories on behalf of California providers over the past 25 years, we have earned a reputation as a "go-to" firm for healthcare matters. Fenton Nelson is the only boutique firm in California to receive a Top-Tier Firm rating in regulatory and administrative law from U.S. News & World Report. Fenton Nelson attorneys defend healthcare providers in investigations before the Medicare Program and its contractors, the FDA, and the widest range of other federal and state regulatory agencies. The firm has tried cases and argued to the California Supreme Court on fraud and abuse, peer review, reimbursement, and healthcare administrative issues, and we negotiated a broad range of transactions for healthcare providers. The firm also provides counsel in transactional and compliance matters to enable clients to achieve their business objectives, implements compliance programs, and oversees compliance as outside counsel for hospitals, long-term and behavioral healthcare organizations, and life sciences companies.
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