Sunshine Act Reporting - Clarification for Clinical Research

Sunshine Act reporting affects every sponsor that pays clinical investigators. The Open Payments Program requires makers of drugs, medical devices and biologics that take part in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals, including clinical investigator payments.

The law was part of a healthcare reform bill passed in March 2010, in response to calls for more transparency about financial ties between physicians and industry.

This 60-minute webinar summarizes the Open Payments requirements and offers practical answers to the situations that come up most often between sponsors and investigators, including reporting templates, exemptions and timelines for compliance and enforcement.

• Explain the purpose of the Sunshine Act and the Open Payments Program
• Identify which manufacturers must report and to whom the payments relate
• Determine what payments and items of value must be reported
• Apply the exclusions and exemptions to reporting
• Set up tracking that supports accurate reporting
• Describe the penalties for non-compliance

• Purpose of the Sunshine Act
• Who is required to report
• What is reported
• Exclusions and exemptions
• Reporting templates and timelines for compliance and enforcement
• Tracking payments
• Penalties
• Useful links

The Sunshine Act places clinical trial reporting duties on sponsors and physicians, and non-compliance can lead to large fines. Life science companies have to put detailed reporting in place, while healthcare providers need to anticipate how payments will appear in public reports.

This session helps drug, device and biotech manufacturers, clinical trial professionals, regulatory affairs staff and senior management plan practical steps for transparency and compliance.

• Manufacturers of FDA-regulated products: Drug, Medical Device, and Biotech Companies
• Clinical Trial Professionals such as Project Managers, CRAs, Medical Writers
• Senior Management for Companies developing new products for the US market
• Regulatory Affairs Professionals
• People investing in FDA-regulated products intended for the US market

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.