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National Pharma Compliance Webinar: Medical Affairs Compliance - Lessons Learned And Best Practices

  • Tuesday, June 7, 2016
  • 1:00 pm - 2:30 pm (Eastern)
  • 12:00 pm - 1:30 pm (Central)
  • 11:00 am - 12:30 pm (Mountain)
  • 10:00 am - 11:30 am (Pacific)

The Webinar agenda is set forth in Eastern Daylight Time below:
1:00 pm Welcome, Introduction and Overview of Legal Framework and Landscape

Brian A. Bohnenkamp, MHA, JD
Partner, King and Spalding LLP, Washington, DC (Moderator)

    Speaker Bio

    Brian Bohnenkamp is a partner in King & Spalding's FDA & Life Sciences Practice based in Washington, D.C. He regularly counsels drug and device manufacturers on a variety of laws and regulations administered and enforced FDA, OIG, DOJ, and CMS, as well as by state attorneys general, boards of pharmacy, departments of health, and similar administrative and enforcement authorities. Mr. Bohnenkamp has extensive experience in counseling manufacturers on fraud and abuse laws, industry codes of conduct, transparency laws and regulations, and government ethics restrictions. He regularly assists manufacturers in designing and implementing comprehensive compliance programs, and conducts risk assessments, audits, and other reviews of compliance programs.
1:20 pm Strategic Planning and the Interface between Medical Affairs and Marketing

Brian J. Conner
Director, Huron Consulting Group, Former Sr. Director, Asst. Compliance Officer, Global Compliance, Shire Pharmaceuticals Atlanta, GA

    Speaker Bio

    Brian is a proven senior-level compliance professional with 22 years of biopharmaceutical industry experience within the areas of corporate ethics and compliance, general management, regulatory affairs, basic R&D, manufacturing, sales/marketing and advertising. Prior to joining Huron, Brian was the Assistant Compliance Officer of the Americas for Shire Pharmaceuticals. He developed and implemented the company's compliance program in the U.S. and Canada within the Specialty and regenerative medicine business units.

    Professional Experience
    Specific areas in which Brian has excelled in the life sciences industry include:
    • Experience in developing, launching, implementing and managing effective US and international compliance programs
    • In-depth industry knowledge of the pharmaceutical, biologics and device industries
    • Strong knowledge of a broad range of compliance risk areas and ability to assess risk and develop solutions
    • Leads high performing teams, managing collaboratively across diverse functions
    • Trusted advisor to the Chief Compliance and Risk Officer, providing guidance on operating the company's global compliance function and managing global compliance and ethics risks to the satisfaction of the Board of Directors
    • Led commercial implementation of the Corporate Integrity Agreement
    • Provided strategic guidance and operational support to all compliance impacted R&D, market access and patient services activities, including medical affairs, health outcomes organizations, corporate accounts, government accounts and HUB services
    • Managed the monitoring, audit and investigation of activities and programs that present compliance risks
    • Identified and assessed regulatory risks associated with product promotion and then define strategies to mitigate those risks
    • Conducted annual risk assessments and management exercises that supported and empowered the business to effectively address business and compliance risks
    • Merger and acquisition compliance lead for due diligence and core integration activities
    • Develop effective compliance training programs, including appropriate introductory training for new employees as well as ongoing training for all employees and managers

    Bachelor of Science (Biology/Teacher Preparation) Drexel University, Philadelphia PA
1:40 pm Customer-Facing Medical Affairs Roles: Medical Affairs Interactions with HCPs and Managed Markets Accounts

Kevin Ryan, JD, MS
Senior Director, Compliance: New Products, Novo Nordisk New York, NY

    Speaker Bio

    Kevin Ryan is a Senior Director in the Novo Nordisk Inc. Compliance Department. He oversees a team responsible for the monitoring and auditing efforts related to several Novo Nordisk products as well as the company's health care compliance related REMS requirements. Kevin also has responsibility for Novo Nordisk's risk assessment and mitigation program (RAMP). Prior to joining the Novo Nordisk Compliance Department, Kevin was Corporate Counsel in the Novo Nordisk Legal Department. He joined Novo Nordisk after working at several private law firms and as a discovery research scientist for a leading pharmaceutical company.
2:00 pm Medical Affairs: Operations and Measurement

Kevin L. Espinoza, MBA
Global Vice President, Ethics & Compliance, BTG International Former R&D Compliance Officer, Forest Laboratories (now Allergan) Durham, NC

    Speaker Bio

    Kevin Espinoza, Global Vice President of Ethics & Compliance at BTG International, has spent over a decade introducing, leading and managing Pharmaceutical and Medical Device Compliance Programs. Kevin's roles have included that of a Healthcare Compliance Officer, R&D Compliance Officer and responsibilities for various companys' Anti-Corruption Programs. Kevin's experience includes an FCPA matter with the US SEC, as well as preparation, negotiation and implementation of agreements with US DOJ and US OIG of HHS. Prior to his work in Compliance, Kevin served in various sales, marketing, and corporate affairs roles at a large Pharmaceutical Manufacturer. Kevin and his family, along with a stable of animals, live in Wake Forest North Carolina, USA.
2:20 pm Q&A
2:30 pm Webinar Adjournment

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