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.
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.
- 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 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.
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