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Understanding Corporate Integrity Agreements/Trends: What Can We Expect and Why Is It Important?

Track:
Regulation of Product Advertising and Marketing in an Ever-changing World

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
234

Room Number:
7A

Level:
Intermediate

Type:
Session

Title:
Understanding Corporate Integrity Agreements/Trends: What Can We Expect and Why Is It Important?

Chair(s):
Philomena McArthur, JD
Senior Director, Regulatory Compliance
Johnson & Johnson International, United States

Description:
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(s):
Discuss the impact of corporate integrity agreements on the broader organization; Identify key CIA trends and how to proactively address them.

Presentation(s) & Speaker(s):
Industry Perspective
Paul James Savidge, JD, MBA
United States

Industry Perspective
Bhavana Desai, MBA
Senior Director, Business Compliance, GSM, Medical Affairs, and R&D
Allergan, Inc., United States

Industry Perspective
Mary E. Bradley, PharmD
Healthcare Compliance Officer, Pharmaceuticals Group
Johnson & Johnson, United States

Industry Perspective
Janet W. Steiner, BSN, MS, RN
Senior Director, Global Compliance and Risk Management
Shire, United States