Semi-Annual IVD Clinical & Regulatory Affairs Conference

December 12-13, 2019 | San Diego, CA

Andaz San Diego Hotel

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DISTINGUISHED PRESENTERS INCLUDE:

REGULATORY EXPERTS:

Doug Rheinheimer
Third Party 510(k) Team
FDA

Julien Senac, PhD
Global Director – IVD Focus Team
TÜV SÜD

Michael Ryan
Partner
MCDERMOTT WILL & EMERY

Paul Radensky, MD
Partner
MCDERMOTT WILL & EMERY

Beverly Lorell, MD
Senior Medical & Policy Advisor
KING & SPALDING

Yarmela Pavlovic
Partner
HOGAN LOVELLS

Marian Lee
Partner
GIBSON, DUNN & CRUTCHER

LIFE SCIENCE EXPERTS:

Brad Spring
Vice President, Regulatory Affairs
BD

Sid Mathur
Regulatory Affairs Director, Companion Diagnostics
MERCK

Bertrand Plouffe, M.Sc.
Director – Clinical Study Design
SIEMENS HEALTHINEERS

Rob Guigley
Vice President, Market Access
AMBRY GENETICS

Oliver Liesenfeld, MD
Chief Medical Officer, Head of Clinical Affairs
INFLAMMATIX, INC.

Hilary Baldwin
Regulatory Manager, Quality and Regulatory Affairs
CARIS LIFE SCIENCES

Ronald Dunn
Vice President Global Regulatory and Clinical Affairs
LUMINEX CORPORATION

David Jackson, PhD
CEO
NEURAPTIVE THERAPEUTICS

Kristin Godfredson
Sr. Director, Regulatory Affairs & Quality Systems
BIOTHERANOSTICS

Ashanti Brown
Regulatory Affairs Specialist
BD

Renee Howell, PhD
Senior Director, Clinical Affairs
SIEMENS HEALTHINEERS

Tammy Moncur
VP, Quality & Regulatory Affairs
AMBRY GENETICS

Julia Yeh
Director IVD/Device Regulatory Affairs
AMGEN

Stephanie Ibbotson
Director, Market Access and Reimbursement Affairs
LUMINEX CORPORATION

Laura Tracy
Senior Regulatory Affairs and Clinical Quality Assurance Professional
LEICA BIOSYSTEMS

Taranjit Samra
Head of Quality (Software-IVDs)
GUARDANT HEALTH

Lisa Charter
Director, Regulatory Affairs
23ANDME

Aastha Kohli
Director, Global Regulatory Affairs
NOVARTIS

Elizabeth Somers
Director, Diagnostics
EISAI, INC.

Gail Gasior
Senior Manager, Clinical Compliance
HOLOGIC

Teresa Raich, PhD
Senior Director, Regulatory Affairs
ABBOTT

Matt Marton, PhD
Executive Director, Companion Diagnostics & Genomics
MERCK

Tiffany Miller
Senior Director, Regulatory Affairs
ORASURE

Grace Lee
Principal Regulatory Affairs Specialist
AGILENT TECHNOLOGIES

Kenneth Bloom, MD
Chief Medical Officer of Konica Minolta Precision Medicine
INVICRO AND AMBRY GENETICS

Karla Grasso
Clinical Research Manager
ABBOTT

Karin Hughes, PhD
Vice President Clinical & Regulatory Strategy
ASTUTE MEDICAL

Russell Henderson
Director of Regulatory Affairs International
MYRIAD GENETICS

Jeff Hergesheimer
Manager, Regulatory Affairs
HOLOGIC

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