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Opportunities for Innovation Under Fragmented Regulatory Framework for Clinical Development
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD
Component Type: Forum
Level: Intermediate

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; 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

Speakers
AR

Adriana Racolta

Director, Regulatory Affairs, Companion Diagnostics, Pfizer Inc, United States
Adriana is a Director of Regulatory Affairs, Companion Diagnostics, within the Global Regulatory Strategy for Oncology group at Pfizer Inc. supporting clinical co-development of drug and in-vitro diagnostics. Prior roles include regulatory affairs for Seagen, Inc, Foundation Medicine... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  06: PersonalizedMed-ComboProd-Diagnostics, Forum

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