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Sunshine Act Reporting: Clarification for Clinical Research - Webinar

  • ID: 4900051
  • Webinar
  • July 2018
  • Region: Global
  • 60 Minutes
  • Compliance Online
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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
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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 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 establish more robust quality systems so that the company can succeed.
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