Sunshine Act Reporting: Clarification for Clinical Research
Instructor:
Danielle DeLucy
Product ID: 705747
- Duration: 60 Min
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
Danielle DeLucy
Owner, ASA Training and Consulting, LLC
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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Refund Policy
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
