Human Subjects Research, Healthcare interested in exploring the field of Clinical Research, Clinical Research Coordinators, Principal Investigators/Physicians, Administration in charge of Clinical Research, Regulatory Compliance
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. (see
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Syllabus:
The Sunshine Act: Reporting for Clinical Trials
Why Should you Attend:
The Sunshine Act exposes the physicians and sponsors to new reporting requirements which are unprecedented in their scope and detail noncompliance to which would lead to hefty fines. This webinar will summarize the new requirements and provide practical solutions to most common situations that are prevalent and necessary between sponsors and investigators. Templates for reporting format, acceptable accounting practices, exemptions to reporting requirements, and timelines for compliance and enforcement will be discussed.
You will take away a better understanding of how project management can assist you in performing your role in your organization.
Objectives of the Presentation:
Scale Project Scope Statements
Develop the business case for your own projects
Identifying and managing stakeholders
Develop your Project Plan
Itemize your Work Breakdown Structure and activity list
Enhance your Communications Plan
Identify, plan and manage project risks
Manage changes to the project
Report on status
Drive decisions from the team and from key stakeholders
Seminar Summary:
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. (see
full course description)
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