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Understanding Corporate Integrity Agreements/Trends: What Can We Expect and Why Is It Important?
Session Chair(s)
Philomena McArthur, JD
VP, Global Policies, Procedures & Training, Health Care Compliance & Privacy
Johnson & Johnson International, United States
In the past few years the scope of Corporate Integrity Agreements (CIAs) has evolved and broadened, affecting a greater variety of company activities, including both “promotional” and “non-promotional” areas, such as R&D and medical affairs activities. This increase in scope raises significant questions for companies, including understanding the impact on the broader organization. The CIAs that will be discussed may be US based, but the issues they cover are global. Whether you are US or globally focused, from regulatory affairs, medical, clinical, compliance or legal, this session is relevant to you and will help you understand the key CIA trends, their impact, and considerations in how to proactively address them.
Learning Objective : Discuss the impact of corporate integrity agreements on the broader organization; Identify key CIA trends and how to proactively address them.
Speaker(s)
Industry Perspective
Paul Savidge, JD, MBA
Spark Therapeutics, Inc., United States
Senior Regulatory Counsel
Industry Perspective
Bhavana Desai, MBA
Allergan, Inc., United States
Senior Director, Business Compliance, GSM, Medical Affairs, and R&D
Industry Perspective
Mary E. Bradley, PharmD
Johnson & Johnson, United States
Healthcare Compliance Officer, Pharmaceuticals Group
Industry Perspective
Janet W. Steiner, BSN, MS, RN
Shire, United States
Senior Director, Global Compliance and Risk Management
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