Conference on The Sunshine Act: Reporting for Clinical Trials

Overview: 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.

Why should you attend: Anyone required adhering to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. 

Areas Covered in the Session:

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

Who Will Benefit:

• 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

Speaker :

Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. 

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook. 

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.

Price : $139.00 

Contact Info:

MentorHealth

Phone No: 1-800-385-1607

FaX: 302-288-6884 

support@mentorhealth.com

Event Link: http://bit.ly/The-Sunshine-Act-Reporting-for-Clinical-Trials

http://www.mentorhealth.com/