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#266: Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development of Medicines and Diagnostics
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
204ABC
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-598-L04-P; CME 1.00; RN 1.00

This session will focus on evaluating key global regulatory challenges in combined clinical trials and harmonization of clinical practices to support medical research innovation.

Learning Objectives

Evaluate the challenges of conducting clinical studies in the US and Europe within a fragmented regulatory landscape; Describe how to analyze specific clinical trial challenges at the intersection of IVDR and CTR; Explain key solutions proposed by COMBINE project recommendations and outlining forward-looking strategies for successful implementation.

Chair

Adriana Racolta, PhD, RAC

Speaker

Pharma Industry Approaches to Harmonize Conduct of Trials Under Fragmented Global Regulatory Frameworks
Lauren Tobe, JD

Diagnostic Industry Perspective and Experience: Innovative Regulatory Approaches for Implementing Diagnostic Testing in Clinical Development of Medicines
Jennifer Tucker, MA

EMA Perspective
Stiina Aarum


Speakers
avatar for Stiina Aarum

Stiina Aarum

Senior Scientific Specialist, Scientific Advice, Product Development Scientific, European Medicines Agency, Netherlands
AR

Adriana Racolta

Director, Regulatory Affairs, Companion Diagnostics, Pfizer Inc, United States
Adriana Racolta, PhD is an industry professional with 12 years of experience in the field. As a Director of Regulatory Affairs at Pfizer Inc., she spearheads the company's efforts to implement diagnostic regulatory requirements in support of precision medicine development. In this... Read More →
avatar for Lauren Tobe

Lauren Tobe

Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing digital health technologies, artificial intelligence, and medical devices. Her role involves collaborating with industry leaders, regulators and other important stakeholders... Read More →
avatar for Jennifer Tucker

Jennifer Tucker

Global Head of Regulatory Affairs, Pathology Lab, Roche Diagnostics, United States
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Forum |   09: Regulatory, Forum |   02: ClinTrials-Ops, Forum
  • Level Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

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