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.
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.
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 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.
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.
Danielle DeLucy
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 …
Understanding the Artificial Intelligence Landscape
Holiday Stress and Loss: The Art of Stress Resilience in E…
Establishing Appropriate Quality Metrics and Key Performanc…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Is Your Culture Working For or Against Your Success? If You…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Using High-Performance Coaching for Managers to Address Per…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Red flags that can render your OSHA Safety Program Complete…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
The Human Element of Leadership in the Hybrid Work Experien…
Transform Data into Insights: A Beginners Guide to Excel Pi…
What If Analysis Tools in Excel: Goal Seek, Solver, and Dat…
How to Navigate Political Speech in the Workplace
Project Management for administrative professionals
How to Prepare For and Host a FDA Inspection and Respond to…
Mastering Year-End Payroll and Tax Compliance for 2024
3-Hour Virtual Seminar on Chat GPT for Project Management i…
Eliminate Harmful And Unproductive Drama In The Workplace
FDA Technology Modernization Action Plan (TMAP) and Impact …
The Anti-Kickback Statute: Enforcement and Recent Updates
5 Key Components of Good Manufacturing Practices to obtain …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Team Synergy: How to Harness Collective Intelligence to Max…
Managing Toxic & Other Employees Who Have Attitude Issues
Protect Your Company With The End of the Year HR Checklist
Successful Strategies for FDA Expedited Pathways for Your D…
The Power Of Trust In The Workplace- Improving Your Career …
Do's and Don'ts of Giving Effective Feedback for Performanc…
So, You’re Now the “Boss”: Essential Skills to Succeed as a…
Onboarding is NOT Orientation - How to Improve the New Empl…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Construction Lending And Real Credit Administration: Evalua…
Building GMP Excellence: A Guide to Implementing Compliant …
Improving Employee Engagement & Retention Through Stay Inte…
4-Hour Virtual Seminar on Transformational Leadership - The…
Understanding cognitive load in medical device design
Human Error Reduction Techniques for Floor Supervisors
Excel Power Skills: Master Functions, Formulas, and Macros …
