pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress
pharmaceutical compliance congress



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    Day III: Pharma Congress
    Friday, October 23, 2015





    CLOSED SESSION: INDUSTRY-ONLY COMPLIANCE BEST PRACTICES THINK TANK







(Industry-only session for pharmaceutical company compliance professionals and in-house counsel only)



8:30 a.m.





Introduction to Day Three

Matthew D'Ambrosio, JD, MBA
Senior Vice President, Chief Compliance and Ethics Officer, Sunovion Pharmaceuticals, Inc., Marlborough, MA (Co-chair)

    Speaker Bio

    Matthew D'Ambrosio is currently Senior Vice President, Chief Compliance and Ethics Officer at Sunovion Pharmaceuticals Inc.

    Prior to joining Sunovion, Mr. D'Ambrosio served as Vice President, U.S. Legal Affairs and Chief Compliance Officer at Prostrakan, Inc.

    Previously, Mr. D'Ambrosio served as Chief Compliance Officer for Reliant Pharmaceuticals, Inc., one of the country's largest privately-held pharmaceutical companies which was acquired by GSK in 2007. He began his career with Johnson & Johnson where he headed compliance programs in each of J&J's three core sectors: Pharmaceuticals, Medical Device & Diagnostics and Consumer Products

    Mr. D'Ambrosio was previously adjunct faculty at Seton Hall Law in the Health Law Program.






Gary Del Vecchio
Executive Director, US Pharmaceutical Compliance and Ethics, Bristol-Myers Squibb Company, Plainsboro, NJ (Co-chair)

    Speaker Bio

    Mr. Del Vecchio has been with Bristol-Myers Squibb for 26 years. His experience includes roles within manufacturing operations, quality control and assurance, global manufacturing supply chain, systems implementation, education and training, and compliance and ethics program development and support. Gary has been a member of the US Pharmaceuticals Compliance and Ethics department for 10 years and currently holds the position of Executive Director, USP Compliance and Ethics. In this role he provides compliance and ethics leadership to the Sales, Marketing, Medical, Access and Global Commercialization organizations along with managing the US Compliance and Ethics investigations team. His initial compliance role focused primarily on the creation and implementation of the company's comprehensive US Compliance and Ethics education and training program. Gary is currently serving as a Co-Chair of the Pharmaceutical Compliance Forum, a coalition of senior compliance professionals and legal counsel from approximately 65 of the largest research-based pharmaceutical manufacturers. The PCF was founded in 1999 by compliance professionals from the pharmaceutical industry to promote effective corporate compliance and ethics programs.






James Gibney
Senior Director of Compliance, Regeneron Pharmaceuticals; Former Director, Worldwide Programs and US Investigations - Corporate Compliance, Pfizer, Tarrytown, NY (Co-chair)

    Speaker Bio

    Jim Gibney is Senior Director of Compliance. Jim and his team are responsible for leading efforts to enhance and manage all elements of an effective compliance program. Responsibilities include policy development, developing and delivering company-wide compliance training, Federal and State aggregate spend reporting, development and management of anti-bribery/anti-corruption program, executing a compliance communication strategy, and maintaining an internal monitoring program.

    Jim began his career at Pfizer in 1992 and has held various positions in sales, operations, and compliance.

    Jim served 9 years in the United States Naval Reserve and is a graduate of Rutgers University.






Elizabeth V. Jobes, Esq.
Head of Corporate Counsel and Legal Counsel, Spark Therapeutics, Philadelphia, PA (Co-chair)






Glenna Shen, JD, MBT
Executive Director, Worldwide Compliance and Business Ethics, Amgen Inc., Thousand Oaks, CA (Co-chair)

    Speaker Bio

    Glenna Shen is Executive Director, Compliance with responsibility for the US Business and Global Functions at Amgen. Ms. Shen joined Amgen in 2000, and has held various positions in the Law Department and with Worldwide Compliance and Business Ethics, most recently heading up the Compliance function at Onyx Pharmaceuticals, and Amgen subsidiary. Ms. Shen obtained her Bachelor of Arts degree in Biology from the University of Miami and her Juris Doctor and Master of Business Taxation from the University of Southern California.






Including an Update from PhRMA
Jeff Francer, Esq.
Vice President and Senior Counsel, PhRMA; Former Associate Chief Counsel, Food and Drug Administration, Washington, DC






Lauren K. Roth, Esq.
Assistant General Counsel, PhRMA, Washington, DC

    Speaker Bio

    Lauren Roth is an Assistant General Counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade association representing the leading innovative biopharmaceutical research companies. Ms. Roth advises PhRMA on issues and advocacy related to government enforcement and corporate compliance with federal health care program laws and regulations. Ms. Roth also administers pharmaceutical company certifications to PhRMA's principles of conduct, including the Code on Interactions with Healthcare Professionals ("the PhRMA Code").










12:00 p.m.



Congress Adjournment







ATTENDANCE OF CLOSED SESSIONS LIMITED

As noted above, attendance in the closed session is limited to company compliance professionals and in-house counsel only. The purpose of the closed session is to permit the attendees to engage in a more focused exchange of views regarding issue priority and best compliance practices. Upon registration, attendees will indicate if they plan to attend the closed session. If there is a question raised regarding qualification to attend the closed session, a member of the Congress planning committee will make the final determination.




Go to Agenda:
Preconference / Day 1 | Day 2




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