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B
Berlin, Rob
GSK
Frontiers in Digital Technologies, When the New Approach Exceeds the “Gold Standard”
Location: Concourse B
Rob Berlin
Favorite
Post-guidance Opportunities and Challenges with Prescription Drug Use-Related Software
Location: Concourse B
Rob Berlin
Favorite
Blackmon, William
Teleflex
Preconference Workshop: Project Management in Global Regulatory Affairs for Product Lifecycle Maintenance
Location: Concourse C
William Blackmon
Favorite
Bowen, Linda
Pfizer
The Importance of Precedent in Developing a Regulatory Strategy
Location: Concourse B
Linda Bowen
Favorite
Burde, Stefan
TÜV SÜD
How Do I Get/Keep My IVD Device on the European Market?
Location: Concourse C/D
Stefan Burde
Favorite
E
Ekuta, Jethro
Alexion, AstraZeneca Rare Disease
Global Orphan Drug Regulatory Frameworks
Location: Concourse B
Jethro Ekuta
Favorite
Opening Plenary Session: Regulatory Affairs as a Strategic Partner
Location: Concourse B
Jethro Ekuta
Favorite
G
Gattinger, Ginny
SoftwareCPR
Canadian Regulatory Framework for Software-based Medical Devices and Emerging Technologies
Location: Concourse C/D
Ginny Gattinger
Favorite
H
Hall, Melissa
Statera Regulatory Consulting, LLC
Current Insights into the FDA Premarket Landscape
Location: Concourse C/D
Melissa Hall
Favorite
Horner, Marc
Ansys
In Silico Trials for Device Development and Regulatory Review: Outlining the Need for Global Acceptance
Location: Concourse C/D
Marc Horner
Favorite
J
Jump, Michelle
MedSec LLC
Closing Plenary Session: How Cybersecurity and AI Have Changed the Regulatory Strategy Environment
Location: Concourse B
Michelle Jump
Favorite
K
Kalamegham, Rasika
Genentech
Frontiers in Digital Technologies, When the New Approach Exceeds the “Gold Standard”
Location: Concourse B
Rasika Kalamegham
Favorite
Kieffer, Michael
Focused Consulting, Staffing, & Drug Safety, LLC
Global Patient Safety Teams Should Develop the Study's Target Product Profile Safety Section
Location: Concourse B
Michael Kieffer
Favorite
L
Levi, Mark
RTI
Opening Plenary Session: Regulatory Affairs as a Strategic Partner
Location: Concourse B
Mark Levi
Favorite
The Importance of and Preparing the Target Product Profile (TPP)
Location: Concourse B
Mark Levi
Favorite
Levin, Joshua
ASELL LLC
In Vitro Diagnostic Medical Devices
Location: Concourse C/D
Joshua Levin
Favorite
M
Martinez, Mayte
Teleflex
Preconference Workshop: Project Management in Global Regulatory Affairs for Product Lifecycle Maintenance
Location: Concourse C
Mayte Martinez
Favorite
N
Nozawa, Susumu
Siemens Healthineers
Opening Plenary Session: Regulatory Affairs as a Strategic Partner
Location: Concourse B
Susumu Nozawa
Favorite
Use of Standards in Medical Device Global Regulatory Strategy
Location: Concourse C/D
Susumu Nozawa
Favorite
O
Oppenheimer, Darin
BD
Opening Plenary Session: Regulatory Affairs as a Strategic Partner
Location: Concourse B
Darin Oppenheimer
Favorite
P
Pang, Timothy
Citeline
Thinking Beyond Regulatory Approval: The What, Why, When, and How of Pharma Lifecycle Management
Location: Concourse B
Timothy Pang
Favorite
R
Racic, Amra
Veeva Systems
Building Sustainable Ways of Maintaining a Solid Regulatory Strategy
Location: Concourse C/D
Amra Racic
Favorite
Closing Plenary Session: How Cybersecurity and AI Have Changed the Regulatory Strategy Environment
Location: Concourse B
Amra Racic
Favorite
Raman, Divya
Teleflex
Preconference Workshop: Project Management in Global Regulatory Affairs for Product Lifecycle Maintenance
Location: Concourse C
Divya Raman
Favorite
Rhim, Caroline
Evera Regulatory Advisors
Current Insights into the FDA Premarket Landscape
Location: Concourse C/D
Caroline Rhim
Favorite
Rominski, Cassandra
Teleflex
Preconference Workshop: Project Management in Global Regulatory Affairs for Product Lifecycle Maintenance
Location: Concourse C
Cassandra Rominski
Favorite
S
Siegel, Jeff
FDA
Frontiers in Digital Technologies, When the New Approach Exceeds the “Gold Standard”
Location: Concourse B
Jeff Siegel
Favorite
T
Temkin, Eva
Post-guidance Opportunities and Challenges with Prescription Drug Use-Related Software
Location: Concourse B
Eva Temkin
Favorite
Y
Yang, Xi
RTI
The Importance of and Preparing the Target Product Profile (TPP)
Location: Concourse B
Xi Yang
Favorite
Z
Zhou, Karen
Northeastern University
Canadian Regulatory Framework for Software-based Medical Devices and Emerging Technologies
Location: Concourse C/D
Karen Zhou
Favorite
