ABA-MDMA Compliance Conference

Medical Device & Legal Professionals:  A Collaborative Exchange

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Speakers will be added as confirmed

Agenda

Thursday, December 11, 2014

8:00am

Registration 

8:30am

Welcoming Remarks

8:45am - 10:00am

Governance Documents

Your company's governance documents form the foundation of your compliance program. We will discuss hos to ensure that they cover not only the seven elements of an effective compliance program but also what to consider when making sure that they fit the unique needs of your business. Further, as the nature of investigations both in the U.S. and abroad continue to evolve, 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

  • Susan Gillin, Sr. Counsel Office of Inspector General, Health & Human Services
  • Colleen Heisey, Partner, Jones Day
  • Jackie Huber, Vice President of Compliance, MDMA
10:00am - 10:15am

Networking Break

10:15am - 11:15am

Training Documents

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

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

  • Denise Burke, Partner, Waller Lansden Dortch & Davis LLP
  • John Knighton, Chief Compliance Officer, MicroPort Orthopedics
  • Gretchen Randall, Associate General Counsel, Smiths Medical

11:15am - 12:30pm

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 to identify places where opportunities for improvement exist. We will discuss potential ways to leverage existing resources, as well as the following topices:

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

  • Michael Bell, Founder & President, R-Squared Services & Solutions
  • John Blumers, Group Vice President, Legal Compliances, Biomet Spine
  • Carol Poindexter, Partner, Norton Rose Fulbright

12:30pm - 1:00pm

Networking Lunch

1:00pm - 2:00pm

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.

  • Alice Fisher, Partner, Latham & Watkins
  • Harlan Loeb, Chair, Global Crisis and Risk, Edelman
  • Justin O'Brien, Partner, Collora
  • Michael Sullivan, Partner, Ashcroft Group

2:00pm - 4:00pm

Trending Compliance Issues

This session will focus on drilling down on some of the most significant compliance threats facing the medical device industry, including an emphasis on off-label, novel marketing channels and HIPAA.

  • Lisa Clark, Partner, Duane Morris
  • Clinton Mikel, Partner, The Health Law Partners
  • Michael Swit, Partner, Duane Morris
  • Heidi Wendel, Partner, Jones Day

4:30pm

Reception

Edelman DC Office, International Square
1875 I Street, NW, Suite 900, Washington, DC 20006

Friday, December 12, 2014 

8:00am - 9:00am

Networking Breakfast

9:00am - 10:15am

Interviewing Employees

Discussion of techniques and best practices when interviewing employees; Focus on preparing for and conducting interviews; Strategies to identify and avoid ethical pitfalls.

  • Sean McKenna, Partner, Boones Haynes
  • Patrick O'Toole, Partner, Weil Gotshal
  • Jennifer Weaver, Partner, Waller Lansden Dortch & Davis LLP

10:15am - 10:30am

Networking Break

10:30am - 11:45am

Financial Penalty/Exposure Analysis

Discussion of best practices in assessing financial penalties; insight into relator counsel approach to calculating damages; strategies to maintain attorney-client privilege of financial expert work product.

  • David Douglass, Partner, Sheppard Mullin
  • Rachel Grier, Associate, Berg Androphy
  • Gary Keilty, Director, Huron
  • Kevin McDonough, Partner, VMG Health

11:45am - 12:30pm

Board of Directors: Outside Counsel Report

Discussion of best practices when presenting compliance related reports to Board of Directors; Strategies to manage director expectations; Discussion of ethical issues and pitfalls.

  • Joel Androphy, Berg Androphy
  • Michael Clark, Special Counsel, Duane Morris
  • Thomas Strachan, Vice President - Legal, Compliance & Payer Relations, eCardio
  • Fred Wahrlich, Partner, Munsch Hardt

12:30pm - 2:00pm

Lunch

2:00pm - 3:15pm

PR Management

Discussion of how to manage public relatios during early stage of investigation; Best practices in formulating and discussing an on-going investigation with the media; Focus on integration of PR strategy and legal strategy.

  • Alice Fisher, Partner, Latham & Watkins
  • Susan Market, Managing Director, Financial Advisory Services, AlixPartners

3:15pm - 3:30pm

Networking Break

3:30pm - 4:15pm

Disclosure Meeting with Government

Discussion of techniques and best practices during early stage of settlement talks; Determining amount and extent of information disclosed; Discussion of ethical pitfalls.

  • Ross Goldstein, Trial Attorney Department of Justice, Consumer Protection Branch
  • Robert Rhoad, Patner, Crowell & Moring
  • Michael Sullivan, Partner, Ashcroft Group
  • Heidi Wendel, Partner, Jones Day

 

         

 

Sessions and speakers are subject to change without notice. MDMA reserves the right to cancel or reschedule any program, whereupon full registration fees will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of canceled programs, MDMA assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.