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Renaissance Glendale Hotel and Spa

Mar 16, 2015 1:00 PM - Mar 18, 2015 4:30 PM

9495 W. Coyotes Boulevard, Glendale, AZ 85305

Medical & Scientific Communications 2015 Annual Forum

Session 10 Track B: Current Compliance Landscape (Enforcement, Sunshine Act and CIA’s) as they relate to Medical Affairs (Med Comm and MSL) Activities

Session Chair(s)

Juan C. Nadal, MD

Juan C. Nadal, MD

Vice President Medical Communications, Medical Affairs

Bayer HealthCare Pharmaceuticals, United States

Medical Affairs personnel are continuously dealing with increasing changes in compliance related issues. This interactive session will include experts in each of the three topics who will discuss the importance of effective Compliance Practices in our daily jobs. The focus will be in several areas of interest to Medical Information (MI) and MSL professionals.

Current Enforcement Landscape:
In 2014 there were several enforcement initiatives which have had either direct or indirect implications for Medical Affairs personnel. Are you aware of these enforcement initiatives and are you up to date with compliance functions as changes occur to your operations and regulatory environment?

The Sunshine Act:
The Sunshine Act, a part of the Health Care reform bill was adopted in 2010, but was not fully implemented until 2013, when CMS released the final regulations for the Act. Is your organization complying with the Sunshine Act’s mandates? How are other Pharmaceutical Companies complying with the mandates for the Sunshine Act? What have we learned from the four months of 2013 data published on September 30, 2014?

CIA’s:
With many Corporate Integrity Agreements (CIAs) either having come to an end of their term or about to, it is important to consider post-CIA compliance and to discuss how that may impact your respective role and departments responsibilities. How are Medical Affairs (Medical Information / Medical Communications/ Medical Science Liaison) groups changing their approach. Is your organization covering all of the responsibilities for post-CIA compliance? We are sure this topic will generate some great interest and dialogue.

These three topics will focus on Medical Communications and how companies are addressing the above hot topics. During this session, you will have the opportunity to hear from a distinguished panel of experienced professionals and have the opportunity to share best practices. You are invited to attend and participate in a lively discussion that will leave you with great ideas to think about and possibly implement within your company.

Learning Objective : At the conclusion of this session, participants should be able to:
• Discuss the importance of effective compliance in assessing the level of Compliance including audit Readiness at your respective organization
• Describe the current Regulatory Environment as it pertains to Medical Communications and Medical Science Liaisons

Speaker(s)

Cliff  Saffron

Faculty

Cliff Saffron

KPMG LLP, United States

Principal, Life Sciences Regulatory Enforcement & Compliance

Lawrence  Platkin, JD

Faculty

Lawrence Platkin, JD

Bayer Corporation, United States

Vice President, Head of Compliance Center of Excellence

Thomas  Sullivan

Faculty

Thomas Sullivan

Rockpointe Corporation, United States

President

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