CIS Symposium Helps Medical Device Companies Understand Sunshine Act Compliance and Reporting Requirements
The symposium "Sunshine - How to Weather the Storm of Federal and State Regulations," held March 26 in Long Beach, featured a panel of industry experts from CIS and Advanced Orthopaedic Solutions (AOS) who discussed the key federal and state compliance and reporting requirements.
- Los Angeles-Long Beach, CA (1888PressRelease) April 18, 2013 - Compliance Implementation Services (CIS), a leading life sciences consulting firm,recently hosted a breakfast symposium to educate medical device companies on Sunshine Act regulations. The symposium, "Sunshine - How to Weather the Storm of Federal and State Regulations," featured a panel of industry experts from CIS and Advanced Orthopaedic Solutions (AOS) who discussed the key federal and state compliance and reporting requirements.
The symposium featured a case study about AOS's process of building the necessary compliance components to establish a U.S. Commercial Compliance Program. Panelist Paul Doner, Vice President, Operations at AOS explained his company's decision making process, shared implementation highlights and provided an overview of where AOS is now. Since CIS worked closely with AOS to build its compliance strategy, the attendees heard a first-hand account of the company's challenges and successes. Paul said, "CIS greatly helped AOS transform and enhance its approach to compliance. What used to be a collection of manual processes is now a fully integrated and reliable program that allows the company to meet federal and state compliance and reporting requirements, collect high-quality data and enforce compliance controls."
Symposium attendees represented a mix of small and large medical device companies who shared their concerns on topics such as pre-disclosure, the various methods of dealing with meals and promotional materials and the
challenges of working with third-party vendors and their covered recipients (i.e., CROs). Based on a post-event survey, participants found discussions of key federal Sunshine elements and practical application to be of particular
value to their organization. More than half of the audience stated they would make changes to their business decisions as a result of advice given in the program.
CIS designed the program to hone-in on the compliance concerns important to medical device companies in response to actions taken by regulators who have stepped up investigations and settlements within the med tech community.
Program Chair Judy Fox, Director, Transparency Compliance at CIS, said, "We've entered a new era of compliance enforcement as regulators shift attention to include medical device and diagnostics companies in addition to
pharmaceutical manufacturers. With the increased risk of individual liability as well as corporate liability, medical device companies must improve compliance processes and strategies to meet the new standards. You cannot look at
the Sunshine regulations and transparency reporting as separate from a robust compliance program."
Julie Glendrange, Regulatory Specialist at AOS, said, "The attendees had a strong interest in connecting and collaborating, which helped me to develop several valuable relationships with both the experts and my peers who are
facing similar challenges."
About Compliance Implementation Services (CIS)
Compliance Implementation Services (CIS) is a consulting firm focused on helping life sciences clients proactively manage complex compliance requirements. We offer a broad portfolio of services and solutions that expand deep into the clinical, manufacturing and commercial disciplines and that align with our clients' strategic priorities and business operations. CIS continually provides leadership, global regulatory knowledge, industry experience and a problem-solving culture that responds to today's compliance and commercial challenges. For more information, visit www.cis-partners.com.
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