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Tuesday, June 17
 

11:40am EDT

#231 CH: Using Digital Protocols to Unlock Efficiency and Accelerate Clinical Trials
Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD
Component Type: Workshop
Level: Intermediate

Digitized protocols can support more efficient workflows and help clinical operations teams accelerate trials. This interactive session will discuss the benefits of protocol digitization along with strategies and opportunities for adoption.

Learning Objectives

Learn how digital protocols can reduce the time and effort needed to manage trials from end-to-end, ultimately accelerating trials and bringing drugs to market faster; Discover how digital protocols are already driving connections and efficiencies at research sites; Understand how industry peers are addressing protocol digitization, including challenges, opportunities, and learnings.

Speakers
DM

Denise Meade

Vice President, Life Sciences and MedTech, Verily, United States
Tuesday June 17, 2025 11:40am - 12:10pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   02: ClinTrials-Ops, Workshop

1:00pm EDT

#238 CH: Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts
Tuesday June 17, 2025 1:00pm - 1:30pm EDT
L Street Bridge
Component Type: Workshop
Level: Intermediate

This session explores evolving AI policies, governance frameworks, and the path toward harmonized AI regulation to ensure safe, ethical, and effective AI adoption in pharma.

Learning Objectives

Analyze key global AI regulations and their impact on pharmaceutical R&D and compliance requirements; Distinguish between different regional AI regulatory frameworks and identify strategies for harmonizing AI governance across jurisdictions; Apply best practices for AI risk management, ethics, and lifecycle monitoring in pharmaceutical AI implementation.

Chair

Christina Mack, PhD, MPH

Speaker

Navigating AI Regulation in Pharma: Global Trends, Compliance Challenges, and Harmonization Efforts
Alex Asiimwe


Speakers
AA

Alex Asiimwe

Head of RWE Generation & Partnerships, Gilead, United Kingdom
avatar for Christina Mack

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States
Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →
Tuesday June 17, 2025 1:00pm - 1:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop |   03: Data-Tech, Workshop

3:00pm EDT

#257 CH: Innovative Complex Clinical Trial Designs in Rare Disease Drug Development
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
L Street Bridge
Component Type: Workshop

Currently some activities focus on accelerating rare diseases drug development by using tools and methods such as real-world data, Patient Centred Outcome measures integration, streamlined gene editing and technology transfer platforms, and innovative clinical trials designs.

Learning Objectives

Identify innovative methodologies, technologies and tools for innovative therapy development; Collaborate with an innovative Rare Disease research Ecosystem and recall its funding opportunities.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Speaker
Andrew Thomson, PhD, MA, MS


Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician with over 18 years in the European regulatory system. He is currently in the taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and... Read More →
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  15: Content-Hubs, Workshop
 
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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
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • 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