Best Practices for Updating Your Medical Device Compliance Program by Fortifying Your Protocols, Strengthening Your Team, and Creating a Culture of Living Compliance

March 11, 2015 9:00am

Gael Diane Tisack
Cardiovascular Group Vice President of Legal Affairs & Terumo Americas Vice President of Intellectual Property
Terumo Medical Corporation (Ann Arbor, MI)

Elizabeth Cipolletti
Legal Counsel and Compliance Officer
OMNI (East Taunton, MA)

Teresa Ford
Law Offices of Teresa Ford, PC

In preparation for discussion of the main conference topics, join us for this unique interactive approach to enhancing your medical device compliance program. Benchmark with industry leaders to strengthen your current protocols in this interactive forum. With government enforcers increasingly pursuing fraud and abuse in the medical device industry, don’t miss this unique opportunity to learn best practices and get answers to your company’s specific compliance questions, whether a large or small organization.

  • AdvaMed Code of Ethics on Interactions with Healthcare Professionals
    • How it’s become the industry standard during medical device prosecutions
    • Understanding the distinctions between their codes’ detailed guidance and regulations
    • What role that plays in enforcement, whether you have been certified or not
  • Recruiting and candidate selection: Avoiding FCA exposure and risk management before the interview
  • Making compliance a priority for management
  • How to persuade your sales force to invest in the value of compliance
  • Translating FDA guidance to your sales reps’ medical device pitch
  • Best practices to assist your salesforce on how to remain compliant without stagnating their numbers
  • Creating checks and balances to oversee outside reps and consultants, domestically and abroad
  • How small and medium size organizations can adapt compliance protocols to fit their resources
  • M&A concerns
    • Preparing for an opportunity: How having a well-established compliance program in place can make you a better candidate to be acquired
    • After the ink dries: How to synchronize your culture of compliance with that of the newly acquired
  • Compliance for the C suite: How to organize who serves in what capacity on both a smaller and larger scale
  • To sign or not to sign: The ramifications of business association agreements and other documents that have implications you did not foresee
  • Drafting contracts that satisfy your HCP’s needs while also protecting your interests
  • Transitioning out of old practices to the reality of buying groups: Who is the real target audience now?
  • Conducting internal audits and ensuring confidentiality
  • HIPPA and global digital privacy: Best practices to remain in compliance and manage security risks
  • Considerations for expanding into pharma or combination devices