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Agenda Links: Preconferences/Day 1 | Day 2
AGENDA: DAY 3
WEDNESDAY, NOVEMBER 8, 2017
INDUSTRY-ONLY COMPLIANCE BEST PRACTICES THINK TANK
(Industry-only session for pharmaceutical company compliance professionals and in-house counsel only)
8:30 am
Introduction to Day Three
Jeffrey M. Kawalek, MBA
Senior Director, Ethics & Compliance, North America, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ (Co-chair)
Senior Director, Ethics & Compliance, North America, Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ (Co-chair)
Jeffrey Kawalek is a compliance professional with seventeen years of pharmaceutical experience with a focus on developing and implementing effective pharmaceutical compliance programs, mitigating risk, and advancing compliance with Company policy and Federal and state healthcare laws. Jeff is the Senior Director, Ethics and Compliance, North America for Ipsen Biopharmaceuticals, Inc. Previously, he worked at Novo Nordisk supporting the Chief Compliance Officer to set and accomplish the strategic objectives of the corporate compliance program. He contributed to the development of the compliance program and had responsibilities leading various functions including: Federal [Sunshine] Open Payments and state reporting, monitor and auditing, risk management, and components of the Corporate Integrity Agreement. He has also supported several global compliance initiatives. He holds a Bachelors Degree in Business Administration from The University of Delaware and an MBA from the Fox School of Business at Temple University.
Jennifer McGee, JD
Chief Compliance Officer, Otsuka Pharmaceuticals, Inc., Princeton, NJ (Co-chair)
Chief Compliance Officer, Otsuka Pharmaceuticals, Inc., Princeton, NJ (Co-chair)
Jennifer McGee is Vice President and Chief Compliance Officer at Otsuka America Pharmaceutical, Inc. She joined Otsuka in January 2011 as Senior Compliance Counsel, overseeing compliance with the Corporate Integrity Agreement, implementation of the company’s Aggregate Spend solution and transparency reporting, and providing compliance support to the CardioRenal and Oncology franchises. Prior to joining Otsuka, Jennifer spent 7 ½ years as a litigation attorney in the White Collar Group at the Washington, D.C. office of Shook, Hardy & Bacon, focused on the representation of pharmaceutical and medical device manufacturers in government investigations. Jennifer also served on active duty in the US Army for more than 13 years, trying more than 70 felony cases, and recently retired from the Army Reserves
Margaret Sparks, JD
Associate Vice President, North America Ethics and Business Integrity, Sanofi, US, Bridgewater, NJ (Co-chair)
Associate Vice President, North America Ethics and Business Integrity, Sanofi, US, Bridgewater, NJ (Co-chair)
Antitrust Admonition
John T. Bentivoglio, JD
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice; Washington, DC
Partner, Skadden Arps LLP; Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, US Department of Justice; Washington, DC
John Bentivoglio is a partner at the law firm of Skadden Arps in the Health Care Enforcement and Regulatory Group in Washington, DC. Before entering private practice, John was an Associate Deputy Attorney General and Special Counsel for Health Care Fraud at the U.S. Department of Justice.
Considerations for Operationalizing the DOJ Evaluation of Corporate Compliance Programs Guidance and HCCA Measuring Compliance Program Effectiveness Guide.
Deep dive/working session on the two recent guidance documents:
— DOJ Evaluation of Corporate Compliance Programs
— HCCA Measuring Compliance Program Effectiveness Guide
— DOJ Evaluation of Corporate Compliance Programs
— HCCA Measuring Compliance Program Effectiveness Guide
Cutting Edge Compliance: What DOJ & SEC Really Think about Effective Compliance
Matt Queler, JD
Principal, Deloitte Risk & Financial Advisory; Former Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice; Former Assistant U.S. Attorney, US Attorney’s Office, District of New Jersey, Washington, DC
Principal, Deloitte Risk & Financial Advisory; Former Assistant Chief, FCPA Unit, Fraud Section, Criminal Division, US Department of Justice; Former Assistant U.S. Attorney, US Attorney’s Office, District of New Jersey, Washington, DC
12:00 pm
Congress Adjournment
Agenda Links: Preconferences/Day 1 | Day 2