Sunshine Act Reporting: Clarification for Clinical Research

This Sunshine Act reporting webinar will discuss new requirements for manufacturers of healthcare products related to report of certain payments and items of value given to physicians and teaching hospitals. It will discuss the reporting format, exemptions and timeline for compliance and practical solutions to most common situations prevalent between sponsors and investigators.

Why Should You Attend:

Life science companies face the challenge of implementing the detailed reporting required by the Sunshine 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, it will summarize the new requirements and discuss practical steps they can take to implement the Act and provide practical solutions to most common situations that are prevalent and necessary between sponsors and investigators. Templates for reporting format, exemptions to reporting requirements, and timelines for compliance and enforcement will be discussed.

Areas Covered in the Webinar:

• Purpose of the Sunshine Act
• Who is required to report under the Sunshine Act?
• What is reported?

Templates for reporting format

• Exclusions
• Tracking
• Penalties
• Useful links

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 US market
• Regulatory Affairs Professionals
• People investing in FDA-regulated products intended for the US market