Agenda Links: Day 2
PRECONFERENCE WORKSHOP
MONDAY, JUNE 26, 2017
7:00 am
Registration Commences
PRECONFERENCE WORKSHOP: COMPLIANCE BASICS FOR MEDICAL AFFAIRS
(Optional; Separate Registration Required)
8:00 am
Welcome and Introductions
Mark DeWyngaert, MBA, PhD
Managing Director, Huron Life Sciences, New York, NY
Managing Director, Huron Life Sciences, New York, NY
Monica A. Kwacinski, PharmD (Invited)
Head of External Medical Affairs, Purdue Pharma L.P., Stamford, CT
Head of External Medical Affairs, Purdue Pharma L.P., Stamford, CT
12:00 pm
Preconference Adjournment and Lunch on your Own
AGENDA: DAY 1
Monday, JUNE 26, 2017
DAY 1 OPENING PLENARY SESSION
1:00 pm
Chairperson’s Welcome and Overview
Mark Lange, JD
Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN (Co-Chair)
Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN (Co-Chair)
1:10 pm
Overview of the Current State of Medical Affairs Functions—Results from a Benchmarking Survey
Brian Conner
Director, Huron Consulting Group; Former Senior Director, Assistant Compliance Officer, Global Compliance, Shire Pharmaceuticals, Atlanta, GA
Director, Huron Consulting Group; Former Senior Director, Assistant Compliance Officer, Global Compliance, Shire Pharmaceuticals, Atlanta, GA
2:00 pm
The Interfaces Between Medical Affairs and Commercial at the Strategic Level
Joanne Lahner, JD
Vice President, GHH Compliance, Merck, North Wales, PA
Vice President, GHH Compliance, Merck, North Wales, PA
Pamela Lonzer, MJ
US Medical Advisor, Shire; Former Associate Director, Global Medical Affairs Compliance, Baxalta; Former Assistant Director, Research and Development-Global Compliance, Astellas Pharma, Chicago, IL
US Medical Advisor, Shire; Former Associate Director, Global Medical Affairs Compliance, Baxalta; Former Assistant Director, Research and Development-Global Compliance, Astellas Pharma, Chicago, IL
2:40 pm
The Evolving Role of Medical Affairs in the Field
James Gibney
Senior Director of Compliance, Regeneron Pharmaceuticals; Former Director, Worldwide Programs and US Investigations, Corporate Compliance, Pfizer, Tarrytown, NY
Senior Director of Compliance, Regeneron Pharmaceuticals; Former Director, Worldwide Programs and US Investigations, Corporate Compliance, Pfizer, Tarrytown, NY
Mark Lange, JD
Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN
Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN
Kevin Ryan, JD, MS
Senior Director, Risk and Accountability, Novo Nordisk, Princeton, NJ
Senior Director, Risk and Accountability, Novo Nordisk, Princeton, NJ
Brian Bohnenkamp, JD, MHA
Partner, King & Spalding, Washington, DC (Moderator)
Partner, King & Spalding, Washington, DC (Moderator)
3:30 pm
Break
4:00 pm
Considerations for Digital Initiatives Applicable to Medical Affairs
Mark Lange, JD
Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN
Assistant General Counsel, Eli Lilly and Company, Indianapolis, IN
4:45 pm
Best Practices in Managing Independent Investigator Study and Research Grant Requests
John Moose, CPA / ABV, MBA
Director, Huron Consulting Group, Chicago, IL
Director, Huron Consulting Group, Chicago, IL
Cynthia (Bongiovanni) Ramirez, R.Ph., M.S.J.
Director, Pharma/Device Events, Global Health Care, LLC., Bellevue, WA, Former Director, USP Compliance & Ethics, Bristol Myers-Squibb, Plainsboro, NJ
Director, Pharma/Device Events, Global Health Care, LLC., Bellevue, WA, Former Director, USP Compliance & Ethics, Bristol Myers-Squibb, Plainsboro, NJ
5:15 pm
Adjournment and Networking Reception
Agenda Links: Preconference | Day 2