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What's Up on the Hill? What Medical Communications Professionals Need to Know (Sunshine Act and Corporate Integrity Agreement) - Roundtable Discussion

Track:
Medical Writing Publication Topics

Day & Time:
March 11, 10:30AM - 12:00PM

Room Number:
Regency Hall 3 & 4

Type:
Session

Title:
What's Up on the Hill? What Medical Communications Professionals Need to Know (Sunshine Act and Corporate Integrity Agreement) - Roundtable Discussion

Chair(s):
Kim Pepitone
Scientific Director
Cactus Communications, Inc., United States

Description:
Different government bodies are responsible for the regulations and/or guidelines around the Sunshine Act ([Sunshine] CMS), corporate integrity agreements ([CIAs] OIG), and social media (FDA). It is important to know which body is responsible for issuing what regulation or guideline in order to know where to look for relevant information and be able to stay current.

There are important operating principles around Sunshine, CIAs, and social media with respect to medical publications. Lack of knowledge of the details can risk one’s ability to be compliant, and can result in government-levied fines and/or other punitive actions.

It is important to know the difference between a regulation and a guideline or draft guideline, and how that difference relates to the work performed by medical publication and communication professionals.

Learning Objective(s):
Identify the government bodies responsible for the regulations and/or guidelines pertaining to Sunshine Act, CIAs, and social media
Define the requirements and operating principles for Sunshine, CIAs, and social medial as relates to medical publications and know the risks for failure to comply
Differentiate the regulations from the guidelines and draft guidelines that pertain to Sunshine, CIAs, and social media in the context of developing medical publications

Presentation(s) & Speaker(s):
What?s Up on the Hill? What medical communications professionals need to know
Kim Pepitone
Scientific Director
Cactus Communications, Inc., United States

What?s Up on the Hill? What medical communications professionals need to know
Frank J. Rodino
President and Founder
Churchill Outcomes Research, LLC, United States

What?s Up on the Hill? What medical communications professionals need to know
Robin Whitsell
Whitsell Innovations, Inc., United States

What?s Up on the Hill? What medical communications professionals need to know
Teresa Peña, PhD
Senior Global Director, Publications, Global Medical Affairs
AstraZeneca, United States

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