Harry Nelson, Co-Founder, Fenton Nelson to Speak at KC’s Legal Series: Understanding Food and Drug Administration’s Consent Form Requirements Live Webcast
New York, NY, November 07, 2012 --(PR.com)-- The Knowledge Group/The Knowledge Congress Live Webcast Series, the leading producer of regulatory focused webcasts, has announced today that Harry Nelson, Co-Founder, Fenton Nelson, will speak at a 2-hour webcast entitled “Legal Series: Understanding Food and Drug Administration’s Consent Form Requirements LIVE Webcast.” This event is scheduled for January 17, 2013 from 12pm-2pm (ET).
About Harry Nelson
Harry Nelson is an attorney who counsels healthcare providers on strategy and regulatory compliance, principally focusing on Medicare, FDA, and state healthcare licensing. He is a co-founding and managing partner of Fenton Nelson, a Los Angeles-based healthcare law firm, where he oversees compliance as outside counsel for over 150 healthcare facilities and businesses, from physician organizations to long-term and behavioral care to life sciences. Under his leadership, the firm has, among other accomplishments, become the only boutique healthcare law firm in California to be designated as “top tier” by U.S. News and World Reports in each of its annual surveys. In addition to his expertise in establishing proactive compliance programs, Harry has successfully resolved hundreds of investigations by federal and state government agencies. Harry is included annually in Southern California Super Lawyers and Best Lawyers in America, among other honors, and speaks frequently on subjects of interest to healthcare business and healthcare attorney groups.
About Fenton Nelson
Fenton Nelson represents healthcare providers, including healthcare professionals, facilities, and other organizations, in litigation, business transactions, and regulatory matters. Although they are based in California, their practice is national in scope.
As a result of their landmark victories on behalf of California providers over the past 25 years, they 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 they 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.
To know more about Harry Nelson and Fenton Nelson, please visit www.fentonnelson.com/
Event Synopsis:
The Food and Drug Administration issued a new consent form requirement for 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 certain specific statements provided by the FDA. The statement is Applicable to clinical trials initiated on or after March 7, 2012, the statements are intended to advise the participants that the clinical trial information is 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’s website: www.knowledgecongress.org
About Harry Nelson
Harry Nelson is an attorney who counsels healthcare providers on strategy and regulatory compliance, principally focusing on Medicare, FDA, and state healthcare licensing. He is a co-founding and managing partner of Fenton Nelson, a Los Angeles-based healthcare law firm, where he oversees compliance as outside counsel for over 150 healthcare facilities and businesses, from physician organizations to long-term and behavioral care to life sciences. Under his leadership, the firm has, among other accomplishments, become the only boutique healthcare law firm in California to be designated as “top tier” by U.S. News and World Reports in each of its annual surveys. In addition to his expertise in establishing proactive compliance programs, Harry has successfully resolved hundreds of investigations by federal and state government agencies. Harry is included annually in Southern California Super Lawyers and Best Lawyers in America, among other honors, and speaks frequently on subjects of interest to healthcare business and healthcare attorney groups.
About Fenton Nelson
Fenton Nelson represents healthcare providers, including healthcare professionals, facilities, and other organizations, in litigation, business transactions, and regulatory matters. Although they are based in California, their practice is national in scope.
As a result of their landmark victories on behalf of California providers over the past 25 years, they 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 they 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.
To know more about Harry Nelson and Fenton Nelson, please visit www.fentonnelson.com/
Event Synopsis:
The Food and Drug Administration issued a new consent form requirement for 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 certain specific statements provided by the FDA. The statement is Applicable to clinical trials initiated on or after March 7, 2012, the statements are intended to advise the participants that the clinical trial information is 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’s website: www.knowledgecongress.org
Contact
The Knowledge Congress
Thomas LaPointe, Jr., Executive Director
1.800.578.4370
www.knowledgecongress.org
Therese Lumbao, Director
Account Management & Member Services
tlumbao@knowledgecongress.org
Thomas LaPointe, Jr., Executive Director
1.800.578.4370
www.knowledgecongress.org
Therese Lumbao, Director
Account Management & Member Services
tlumbao@knowledgecongress.org
Contact
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