START FREE TRIAL

Sunshine Act Reporting: Clarification for Clinical Research

Summary

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. 

Overview

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. 

Who should attend?

  • 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

Expert

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.

FAQ

With a FREE membership you can get one Exclusive Video every 30 days!

With a free memebrship account, you can browse the entire library, buy credits & attend live webinars and read expert posts. Join and explore the coolest complaince platform ever. Feel free to upgrade anytime to view all Exclusive content and get additional benefits for your account.

Do I have to pay to join?

For FREE signups there is no payment required. No Credit Card needed. We also offer EDGE & PRO, paid memberships.

What are the different formats?

There are Live and Recorded, Expert led webinars. Durations vary from 30min to 6hrs. Standards & checklists are in pdf form

What if I am interested in more than one exclusive?

You can upgrade to EDGE memebrship at any time and enjoy unlimited Exclusive viewing. All our memebrships are annual plans.

How many videos can I watch?

As a FREE memebr you get 1 free exclusive video every 30days. You can buy additional videos.

Who are the Experts?

All Experts on our platform are handpicked or referred by other Experts based on years of experience & proven expertise in providing learning & consulting advice.

What if I have questions after watching a video?

We provide first of its kind, Expert on Call service, where you can directly schedule one on one call with the Expert of your choice & discuss.

Free Content

Choose this content or anyone of 100s of Exclusive contents. Get one free exclusive every 30days

Paid Content

Choose from 100s of live and recorded content uploaded by Experts every day

Ready to get started?

Get in touch, or create an account