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Tuesday, June 17
 

12:00pm EDT

#234 RT: Roundtable Discussion: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone A
Component Type: Session

Join the Advanced Therapies Community for a follow up round table discussion tied to session: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease (Monday, June 16 | 3:45pm - 4:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Carolyn Shore, PhD

Speakers
avatar for Carolyn Shore

Carolyn Shore

Director, National Academies, United States
Carolyn Shore serves as global health lead and director of the Forum on Drug Discovery, Development, and Translation at the National Academies of Sciences, Engineering, and Medicine. Before joining the National Academies, Carolyn was an officer on Pew’s antibiotic resistance project... Read More →
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   16: Community-Rounds, Session

12:00pm EDT

#235.1 RT: Roundtable Discussion: Clinical Care vs Research - Walking the Ethical Tightrope Between Advocacy and Coercion and Updating Ethics What's New in Declaration of Helsinki
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone C
Component Type: Session

Join the Bioethics Community for a follow up round table discussion tied to session: Clinical Care vs Research - Walking the Ethical Tightrope Between Advocacy and Coercion (Monday, June 16 | 3:45pm - 4:45pm EDT) and Updating Ethics What's New in Declaration of Helsinki (Tuesday, June 17 | 1:45pm - 2:45pm EDT) . Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Lindsay McNair, MD, MPH, MS

Speakers
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone C Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session

12:00pm EDT

#235 RT: Roundtable Discussion: Building a Regulatory Landscape to Support CMC Innovation
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone B
Component Type: Session

Join the Meaningful Change Working Group Community for a follow up round table discussion tied to session: Building a Regulatory Landscape to Support CMC Innovation (Monday, June 16 | 2:15pm - 3:15pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Allison Radwick, PhD, RPh

Speakers
AR

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States
Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →
Tuesday June 17, 2025 12:00pm - 1:00pm EDT
Exhibit Hall / Zone B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   10: RegCMC-Product Quality, Session

2:55pm EDT

#256 RT: Roundtable Discussion: Alphabet Soup - Utilization of Quality by Design and Risk Based Quality Management in Clinical Trials Data Goverernance
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone B
Component Type: Session

Join the Good Clinical Practices & QA - RBQM Working Group for a follow up round table discussion tied to session: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease (Monday, June 16 | 3:45pm - 4:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Terry Katz, MS

Speakers
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  08: RD-Quality-Compliance, Session |   16: Community-Rounds, Session

2:55pm EDT

#256.1 RT: Roundtable Discussion: Participant Compensation in Clinical Trials and Using Generative AI to Explore our Track Record on Paying Participants
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone C
Component Type: Workshop

Join the Bioethics Community for a follow up round table discussion tied to session: Participant Compensation in Clinical Trials - Exploring Today's Landscape and Unlocking Opportunities (Tuesday June 17 | 10:30am - 11:30am EDT) and Using Generative AI to Explore our Track Record on Paying Participants: What Can we Learn to Support More Diverse Representation (Tuesday June 17 | 4:00pm - 5:00pm EDT) and Using Generative AI to Explore our Track Record on Paying Participants: What Can We Learn to Support More Diverse Representation (Tuesday, June 17, 2025 | 4:00pm - 5:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Lindsay McNair, MD, MPH, MS

Speakers
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone C Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Workshop

2:55pm EDT

#255 RT: Roundtable Discussion: International Regulatory Harmonization for Development of Medicines - A Look at How far We’ve Come and Where We Go From Here
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone A
Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Applying Principles of Global Regulatory Collaboration to Address Chronic Disease (Monday, June 16 | 3:45pm - 4:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session,

Chair

Chaitanya Koduri, DDS, MHS

Speakers
avatar for Chaitanya Koduri

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States
Dr. Chaitanya Koduri serves as the Director of International Government and Regulatory Engagement in the Global External Affairs division of the United States Pharmacopeia. In this capacity, Dr. Koduri oversees international regulatory partnerships involving the United States Pharmacopeia... Read More →
Tuesday June 17, 2025 2:55pm - 3:55pm EDT
Exhibit Hall / Zone A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  16: Community-Rounds, Session |   09: Regulatory, Session
 
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143ABC
144ABC
145AB
146ABC
146BC
147AB
150AB
151A
151B
152AB
201
202A
204ABC
206
207A
207B
209ABC
Ballroom
Ballroom Foyer 3rd Floor
EH
Exhibit Hall / Zone A
Exhibit Hall / Zone B
Exhibit Hall / Zone C
Exhibit Hall Lunch
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
L Street Bridge
Nationals Park
Planet Word
Room 145-147 Lobby
Salon B
Salon C
TBD
Virtual
West Salon
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 19: Networking Opportunities
  • 20: Short-Courses
  • Level
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  • Basic
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  • Keyword
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  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming