The Sunshine Act: Reporting for Clinical Trials

Mukesh Kumar

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The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act.

Course Objective

Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. Participants will able to understand who is required to report under the sunshine act and what is reported under the sunshine act and the exclusions under the sunshine act.

 

Course Outline

  • Purpose of the Sunshine Act.
  • Who is required to report under the Sunshine Act?
  • What is reported?
  • Exclusions.
  • Tracking.
  • Penalties.
  • Useful links.

 

Target Audience

  • Human Subjects Research Professionals.
  • Healthcare Personnel interested in exploring the field of Clinical Research.
  • Clinical Research Coordinators.
  • Principal Investigators/Physicians.
  • Administration in charge of Clinical Research.
  • Regulatory Compliance.
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Speaker: Mukesh Kumar,

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.