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Walther, Elisabeth
US Food and Drug Administration
FDA Proposed New ACNU NDA: A Novel Regulatory Pathway for Increasing Patient Access and Lifecycle Management
Location/Room:513D
Elisabeth Walther
Favorite
Wang, Junyang
EMD Serono
FDA Expectations for using Digital Tools in Decentralized Clinical Trials
Location/Room:513D
Junyang Wang
Favorite
Solutions Circle: FDA Expectations for Digital Health Tools in Decentralized Clinical Trials
Location/Room:Exhibit Hall: Solutions Circles
Junyang Wang
Favorite
Ward, Diane
Qserve Group US
Solutions Circle: Getting it Right the First Time - Where Regulatory and Design Intersect; Accuracy/Acceptance Criteria
Location/Room:Exhibit Hall: Solutions Circles
Diane Ward
Favorite
Wardle, Paul
Beacon Associates, LLC
FDA Proposed New ACNU NDA: A Novel Regulatory Pathway for Increasing Patient Access and Lifecycle Management
Location/Room:513D
Paul Wardle
Favorite
Waterland, Robert
Certara Drug Development Solutions
Solutions Circle: eCTD Module 3, How Much Detail Do I Submit?
Location/Room:Exhibit Hall: Solutions Circles
Robert Waterland
Favorite
Welch, Chelsea
ARUP Laboratories
Companion Diagnostics: Overview of the IVDR Requirements and the EMA Consultation Process
Location/Room:511E
Chelsea Welch
Favorite
Whalley, Chris
Seattle Genetics
Solutions Circle: Transparent, Translucent, and Opaque: How Global Health Authorities Make Information Publicly Accessible
Location/Room:Exhibit Hall: Solutions Circles
Chris Whalley
Favorite
Whitehead, Alfred
Klick Consulting
FDA Proposed New ACNU NDA: A Novel Regulatory Pathway for Increasing Patient Access and Lifecycle Management
Location/Room:513D
Alfred Whitehead
Favorite
Wiersma, Anja
mi-CE consultancy
Solutions Circle: Notified Bodies: IVDR implementation Ask me Anything
Location/Room:Exhibit Hall: Solutions Circles
Anja Wiersma
Favorite
Will EU IVDR implementation benefit from MDCG 2022-14 and if so, HOW?
Location/Room:511E
Anja Wiersma
Favorite
Wierzba, Mike
GSK
Challenges in Implementation of IVDR Requirements for CDx Clinical Performance Studies
Location/Room:513F
Mike Wierzba
Favorite
Williams, Cham
IQVIA
Solutions Circle: Strategies for Holistic Labeling: Information Consolidation, Process Orchestration, Intelligent Automation & Resource Augmentation
Location/Room:Exhibit Hall: Solutions Circles
Cham Williams
Favorite
Wiseman, Bridget
IQVIA
Sponsored Presentation: Managing regulatory change
Location/Room:Exhibit Hall: Spark! Stage (Booth 323)
Bridget Wiseman
Favorite
Wong, Amanda
Haleon Canada
Enabling Global Regulatory Environments to Deliver Better Self Care Interventions
Location/Room:511D
Amanda Wong
Favorite
Woodcock, Janet
United States Food and Drug Administration
Conversations That Matter - Interactions with Health Authorities: Drugs, Biologics and Combination Products
Location/Room:511E
Janet Woodcock
Favorite
Plenary Session: RAPS Patient-Centered Health Award Presentation and Panel Discussion: Progressing Patient-Centered Health Through Collaboration: A TransCelerate Multi-Stakeholder Panel
Location/Room:220 B
Janet Woodcock
Favorite
RAPS Convergence 2023 Welcome & Opening Plenary Session: The Futuristic Regulatory Professional
Location/Room:220B
Janet Woodcock
Favorite
Wright, Waylon
Celegence
Sponsored Presentation: Optimizing CER and PMS Document Writing with Technology and AI
Location/Room:Exhibit Hall: Spark! Stage (Booth 323)
Waylon Wright
Favorite
Wu, Michelle
NyquistAI
Sponsored Presentation: Reimagine Regulatory Affairs in The Era of Generative AI
Location/Room:Exhibit Hall: Ignite! Stage (Booth 623)
Michelle Wu
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