Sunshine Act Reporting - Clarification for Clinical Research

This webinar will summarize the Sunshine Act or Open Payments Program requirements and provide practical solutions to the most common situations that are prevalent and necessary between sponsors and investigators.

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 clinical investigator 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 the industry.

Life science companies face the challenge of implementing the detailed reporting required by the Act as healthcare providers determine how to use their own data to anticipate public reporting of payments by life science companies to physicians and teaching hospitals.
This webinar will examine the implications of the Sunshine Act for healthcare providers and life science companies and discuss practical steps they can take to implement the Act and prepare for transparency.

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

The Sunshine Act exposes the physicians and sponsors to new clinical trial reporting requirements and detail non-compliance which would lead to hefty fines. Templates for reporting format, exemptions to reporting requirements, and timelines for compliance and enforcement will be discussed.

• 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.