2013 Compliance Agenda


MDMA's 2013 Compliance Workshop

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AGENDA

The following experts will be engaged in an open panel discussion on the topics below.  This workshop is intended to be interactive with all participants.

  • Jacqueline Huber, Independent Consultant & Former Chief Compliance Officer, Exactech
  • Adam Jones, Divisional General Counsel, Smiths Medical
  • Jeff Layne, Partner, Norton Rose Fulbright
  • Mark Leahey, President & CEO, MDMA
  • Robert Pereira, Director of Governance, ZOLL Medical Corporation
  • Srini Seshadri, President, Smiths Medical
  • Benjamin Wallfisch, Associate, Norton Rose Fulbright

Thursday, December 12, 2013

8:00am - 8:30am

Registration & Continental Breakfast

8:30am - 8:40am

Welcoming Remarks

8:40am - 10:30am

Review/Discussion of Governance Documents

Your company's governance documents form the foundation of your compliance program. We will discuss how to ensure that they cover not only the seven elements of an effective compliance program but also what to consider to make sure that they fit the unique needs of your business. Further, with the nature of continuing evolution of investigations in both the U.S. and abroad, so must your compliance program continue to evolve and strengthen. We will discuss the following topics:

  • How to Construct Your Compliance Program
  • Code of Conduct
  • Certification Documents
  • Making Compliance Programs Sustainable and Effective

10:30am - 10:45am

Break

10:45am - 11:30am

Review/Discussion of Training Documents

How can you make your training efforts as effective as possible? Training is critical, but how can you make it achieve the goals that you have set?  We will discuss training intended for the following audiences:

  • U.S. Sales Force
  • International Distributors
  • Management, R&D and Marketing

11:30am - 12:15pm

Review/Discussion of Auditing Documents

Robust monitoring and auditing procedures are necessary to test the effectiveness of your company's compliance program and to detect potential areas of weakness, as well as places where opportunities for improvement exist. We will discuss potential ways to leverage existing resources, as well as the following topics:

  • Who is Responsible for Overseeing Compliance
  • Periodic Reviews
  • Annual Audits
  • Ethics Hotline

12:15pm - 1:00pm

Networking Lunch

1:00pm - 1:45pm

What to Do When Problems Arise

This session will focus on best practices in managing investigations, "dawn raid policies" and determining when to self-disclose issues.

1:45pm - 2:30pm

Trending Compliance Issues

This session will focus on drilling down on some of the most significant compliance threats facing the medical device industry.

2:30pm - 4:00pm

Case Studies - Putting the Toolkit to the Test

Attendees will work collaboratively with experts on a variety of situations and discuss the best practices.