The Sunshine Act Reporting for Clinical Trials
May 7, 2013
Location
san Francisco
38868 Salmon Ter, Fremont California 94536
san Francisco, California 94536
USA
Description
Description:
Payments made to clinical investigators participating in clinical trials need to be disclosed to CMS under the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, generally referred to as Obamacare.
Under the new rules, principal investigators and co-investigators are subject to unprecedented disclosure requirements to the Center for Medicare and Medicaid Services (CMS). These disclosures are in addition to the financial disclosure requirements to the FDA under IND regulations. Sponsors are required to collect detailed financial information and report to the CMS, which will verify it with the investigators, after which the information about each individual investigators will be made available on CMS’s website to general public. Non-compliance could subject both the sponsors and investigators participating in clinical trials to hefty fines. This seminar will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting. This seminar would also assist sponsors and investigators to develop standard practices to meet federal requirements.
Additional Information
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.
Organized by
online compliance panel
38868 Salmon Ter, Fremont California 94536
san Francisco, California 94536
United States of America
More Information
Contact: martin luthur
Email: onlinecompliancepanel1@gmail.com
Phone: +1-510-857-5896
Event's Website
