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Bethesda North Marriott Hotel and Conference Center

Mar 03, 2016 7:30 AM - Mar 04, 2016 4:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Marketing Pharmaceuticals 2016

Discuss the complexity of marketing and how to promote pharmaceuticals, biologics, and medical devices in an effective yet compliant manner in an evolving environment.

Session 7C: Review Standards for Ad Boards and Consultant Meetings

Session Chair(s)

Mark  Gaydos

Mark Gaydos

Former Global Head, Advertising & Promotion, Global Regulatory Affairs

Sanofi, United States

Advisory boards and consulting arrangements are common business practices that permit companies to obtain expert advice on matters ranging from clinical development plans, product positioning and promotional messaging, as well as postmarketing studies and other life cycle management activities. While representing standard business practice, such relationships with external health care professionals are fraught with risks that must be acknowledged and accounted for in order to protect companies and individuals from external allegations of illegality. We will explore the legal and regulatory risk areas associated with ad boards and consulting arrangements, from both internal and external perspectives, and discuss steps companies can take to ensure their validity and minimize associated risks.

Speaker(s)

Mark  Gaydos

Advisor and Consultant Arrangements: Avoiding Regulatory Peril

Mark Gaydos

Sanofi, United States

Former Global Head, Advertising & Promotion, Global Regulatory Affairs

Linda  Pissott Reig, JD

Meeting Legal and Regulatory Requirements While Meeting With Your Consultants: Learning From Enforcement Trends

Linda Pissott Reig, JD

Buchanan Ingersoll & Rooney PC, United States

Shareholder

Felecia  Ettenberg, JD

Legal Considerations for Advisory Boards

Felecia Ettenberg, JD

Bristol-Myers Squibb, United States

Executive Director, Promotion Integrity

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