Combination Products Regulation Conference

February 28 – March 1, 2019 | Arlington, VA

Hilton Crystal City at Washington Reagan National Airport

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DISTINGUISHED PRESENTERS INCLUDE:

LIFE SCIENCE INDUSTRY EXPERTS:

Darin Oppenheimer, PhD
Executive Director, Head Drug Device Center of Excellence
MERCK

Ruby Gulati
Head Combination Product Quality
GENENTECH

Diane Radcliffe
Associate Director, Medical Device & Combination Product Quality
MERCK

Michael Song
Sr. Manager, Drug Delivery and Device Development
MEDIMMUNE

Edward Halpern, PhD
Principal Human Factors Research Engineer
ABBVIE

Steven Bruun
Regulatory Affairs Leader – Peripheral and Combination Products
WL GORE & ASSOCIATES

Suzette Roan
Senior Director, Global Regulatory Affairs
SANOFI

Andrea Redd
Senior Director, Regulatory Affairs
FRESENIUS KABI

Dan Visco
Associate Director, Device and Digital Health Center of Excellence
MERCK

Suchitra Basu, PhD
Global Strategy Manager, Regulatory Affairs
DEPUY SYNTHES

Jennifer Recknor, PhD
Product/Technology Specialist, Combination Products Platform – Medical Product Division
WL GORE & ASSOCIATES

Waiss Faissal
Certification Project Manager
GMED NORTH AMERICA

Gary Hartman
Head of Device, Combination Product, and SaMD Quality
ASTRAZENECA

Kirsten Paulson
Sr. Director, Global CMC-Medical Device Lead
PFIZER

Bob Laughner
Regulatory Director, Combination Products and Medical Devices
ASTRAZENECA

Anoop Padival, PhD
Manager, Global Labeling Strategy, Regulatory Affairs
ABBVIE

Andrea Dwyer
Managing Human Factors Specialist
EMERGO by UL

Jaap Laufer, MD, PhD,
Vice President, Regulatory and Clinical Affairs
EMERGO

LEGAL EXPERTS:

Jeff Gibbs
Director
HYMAN, PHELPS, & MCNAMARA

Lina Kontos
Counsel
HOGAN LOVELLS

James A. Boiani
Member of the Firm
EPSTEIN BECKER GREEN