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Thursday, June 19
 

9:00am EDT

Quality Risk Management for a Decentralized/Hybrid Clinical Trial: A Role Play by Representatives of Key Stakeholders
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD
Component Type: Forum
Level: Intermediate

A cross-functional panel of experts will role-play a risk review meeting discussion to identify, assess, categorize, and prioritize risks of a mock protocol DCT and outline potential mitigation activities.

Learning Objectives

Outline why risk identification is a fundamental consideration when planning a Decentralized/Hybrid Clinical trial; Define roles and responsibilities for key stakeholders to identify risks for Decentralized/Hybrid Clinical Trial; Identify who are the key stakeholders for a decentralized/Hybrid Clinical trial; Develop fit-for-purpose Oversight Plans.

Chair

Paula Horowitz

Speakers
avatar for Paula Walker

Paula Walker

Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  02: ClinTrials-Ops, Forum

9:00am EDT

EMA - FDA Question Time
Thursday June 19, 2025 9:00am - 10:00am EDT
TBD
Component Type: Forum
Level: Intermediate

In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.

Learning Objectives

Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

Thursday June 19, 2025 9:00am - 10:00am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum

10:30am EDT

FDA Town Hall
Thursday June 19, 2025 10:30am - 12:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

The FDA Town Hall is the forum to hear from FDA leadership about Center priorities. The audience will be invited to submit questions of general interest.

Learning Objectives

Discuss FDA Center priorities.

Chair

Amy Bertha

Speakers
avatar for Amy Bertha

Amy Bertha

Executive Director, Regulatory Policy and Innovation, Bayer, United States
Amy Bertha is currently Executive Director, Regulatory Policy and Innovation at Bayer. Her prior experience includes, regulatory program and project management at FDA Center for Drugs and Evaluation, regulatory affairs at Pfizer, and research scientist at Hoffman-La Roche. She is... Read More →
Thursday June 19, 2025 10:30am - 12:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Forum
 
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Virtual
  • 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
  • 20: Short-Courses
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  • Tutorial
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