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.
WHY SHOULD YOU ATTEND?
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.
AREA COVERED
- 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
LEARNING OBJECTIVES
- 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
WHO WILL BENEFIT?
- 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
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.
- 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
- 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
- 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