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6th Promotional Review Committee Compliance & Best Practices - Midwest -

6th Promotional Review Committee Compliance & Best Practices - Midwest
May 15–17, 2019
Chicago, IL

The ONLY industry event devoted specifically to uniting cross-team expertise, maximizing quality oversight during review, and improving regulatory compliance in all multimedia promotional messaging

Faculty – 6th Promotional Review Committee Compliance & Best Practices - Midwest

Renee Ambrosio
Director, Advertising and Promotion, Regulatory Affairs, MERCK

Ilze Antons
Senior Director, Regulatory Affairs, LUNDBECK

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Ilze started her career in the pharmaceutical industry at the Upjohn Company in Kalamazoo, Michigan over 25 years ago. Prior to her extensive time in Regulatory Affairs, she held several positions in Quality Assurance. Her regulatory path not only spanned International, US and Global approaches, but also included Pharmacia, Genzyme, Baxter and Serono before Lundbeck. While she worked on INDs, NDAs, DMFs and in numerous therapeutic areas, over the past 17 years her work has included Advertising and Promotional work, with the last 10 focused solely in this area of regulatory compliance. She now heads up a team that provides promotional review and internal as well as external compliance training, and has been involved with the development and inclusion of social media in various programs in the company.

Ilze received her B.S. from Purdue University and her M.S. from The Ohio State University. She is RAC certified; participated in developing the original Code of ethics for Regulatory Professionals for RAPS; was an organizer for RAPS’s annual meetings; and has been a presenter on both labeling and advertising, and promotional topics at various conferences.

Jason Benagh
Manager, Marketing Operations, ALKERMES

Bill Benvenuto
VP, Legal Affairs and Chief Compliance Officer, RETROPHIN

Christi Bruce
Senior Manager, MLR Operations and Platforms, SANOFI

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Christi joined Sanofi in 2006 and has held several roles increasing in responsibility during her time with the company. She has been responsible for the U.S. Advertising and Promotion process since 2009. Currently, she is part of the Promotional Excellence & Standards group in Global Regulatory Affairs, as the U.S. Country Lead responsible for overseeing and managing activities associated with the U.S. Commercial Materials Review Process. Along with being the subject matter expert in the US, as part of her role, she is working to harmonize processes across all threeSanofi business entities.

Rebecca Burnett
Executive Director and Head of Strategic Services, FRAMEWORK SOLUTIONS INC.

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In her current role as Executive Director and Head of Strategic Services for Framework Solutions, Rebecca Burnett has more than 17 years of biopharmaceutical industry experience. She was most recently the Head of North America Marketing Operations for Mylan where she was responsible for leading her team in the support of five business units and more than 1,400 products.

Ms. Burnett began her career as a clinical research associate and held numerous roles in clinical research and medical affairs before finding her true passion in advertising and promotional review management in 2008. Since that time she has worked with and led teams across a spectrum of biopharmaceutical companies. Her teams have won industry awards for excellence in implementing technology solutions to drive process review efficiency and optimization. Her expertise is in diagnosing and providing recommendations to promotional review teams to ensure compliant and efficient review processes.

Ms. Burnett received her undergraduate and masters degree from the University of Colorado and has an MBA from George Washington.

Rebecca Burns
Medical Affairs Manager, ARBOR PHARMACEUTICALS

Nan Clarke
Manager, Promotional Marketing Operations and Compliance, ABBVIE

Bradley Coushman
Vice President, ELMIS CORP

Steve Gersten
Vice President, General Counsel, and Chief Ethics and Compliance Officer, DYNAVAX

Heather Goldstein
Marketing Services Effectiveness Manager, TAKEDA

Anghela Gonzales
PRO Associate Manager, GENENTECH

Nan Knickerbocker, CQM, RAC
Associate Director Regulatory Affairs, U.S. Advertising and Promotion, ABBVIE

Peter Lee
Vice President, Chief Compliance Officer, HERON THERAPEUTICS

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Peter Lee received his B.A. from the University of Michigan and his J.D. from Quinnipiac Law School. He has a master’s in health law from Loyola University of Chicago and almost 20 years of experience building compliance programs in healthcare for hospitals, managed care organizations and pharmaceutical companies. He has held compliance and privacy officer positions at Sutter Health and Accenture, and has built compliance programs at Gilead Sciences, Hyperion Therapeutics and Pharmacyclics. He is currently Vice President of Compliance at Heron Therapeutics.

Kim Maney
Senior Counsel, GSK

Robert Masi
Associate PRO Specialist, GENENTECH

Cristina Masseria
Methods and Capabilities Lead, PFIZER

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Cristina is currently leading the Methods and Capability team for HEOR and Market Access at Pfizer. Cristina has extensive experience in HEOR and RWD generation and communication in Pharma (Pfizer and GSK).

Before joining the pharmaceutical industry in 2011 at GSK, Cristina was a lecturer at the London School of Economics. She led various health policy initiatives with the European Commission and OECD. Cristina holds a PhD in economics, an MSc in economics, and an MSc in Health Economics.

Nneka Onwudiwe
Regulatory Reviewer, USA

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Nneka C. Onwudiwe, Ph.D., Pharm.D., MBA, received her doctorate in Pharmacy (Pharm.D.) from the University of Maryland School of Pharmacy, Ph.D. in Health Services Research with a specialization in Pharmacoeconomics from the University of Maryland School of Pharmacy, and an MBA (Honors) from the University of Baltimore. In addition, she received an honor of Rho Chi in Pharmacy in 2002 and an honor of Beta Gamma Sigma in Business Administration in 2012.

Dr. Onwudiwe is a Patient-reported outcomes (PRO) and Pharmacoeconomics (PE) Regulatory Review Officer at the Food and Drug Administration (FDA). Dr. Onwudiwe is the technical expert and point of contact in the review of PRO, PE, and other types of claims in prescription drug promotion for the Division of Advertising and Promotion Review II (DAPR II) within the Office of Prescription Drug Promotion.

Dr. Onwudiwe teaches Comparative Effectiveness Research (CER) & Pharmacoeconomics at the University of Maryland School of Pharmacy. Dr. Onwudiwe has received several awards and accolades over the years. She has received funding as a Principal Investigator from NIH/NHLBI. Dr. Onwudiwe currently serves on the Food and Drug Law Institute’s (FDLI) Publications Peer Review Committee as well as a member of the ISPOR Value Assessment Frameworks Stakeholder Advisory Panel.

Dr. Onwudiwe has served on several ISPOR Scientific and Health Policy Working Groups (Task Forces and Special Interest Groups) that have developed products and tools used by decision makers and researchers around the world. She is currently serving on the Value Assessment of Medical Device Special Interest Group and Statistical Methods in Health Economics and Outcomes Research Special Interest Group. In addition to this work, Dr. Onwudiwe has presented at various professional conferences and published in several peer-reviewed journals such as Value in Health Regional Issues, Spine, Journal of the American Medical Association (JAMA), Obesity, Oncologist, Cancer Medicine, and Ethnicity and Disease.

Dr. Onwudiwe holds a license in pharmacy and practices as a pharmacist in the community providing medication therapy management (MTM) and other services.

Brad Patrick
Division Counsel, ABBVIE

Alexander Shaw
Manager Medical Information, ALKERMES

Keren Tenenbaum
Assistant General Counsel, PFIZER

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Keren Tenenbaum is an Assistant General Counsel at Pfizer’s Legal Division. Prior to joining Pfizer, Ms. Tenenbaum was an associate at DLA Piper’s litigation department in New York.

Sandra Vladisavljevich
Sr Director, Regulatory Advertising and Promotion, TAKEDA

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