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 participating 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.
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.AREA COVERED
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
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?
- Useful links
- 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 the 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 providing 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 to establish more robust quality systems so that the company can succeed.
We enhance global compliance, where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety. Our interactive training sessions could be beneficial to corporations thriving in industries such as pharmaceuticals, drugs and chemicals, FDA compliance, medical devices, packaging and labeling, food and beverages, banking and finance, audits and inspections, recalls and crisis management and learning portal devoted to advancing quality learning through conferences and online training (webinars & webcasts) Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline.