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Thursday, June 29 • 8:30am - 9:30am
A Global Sponsor Perspective on Implementation of the New EU Clinical Trials Regulation

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Component Type: Session
Level: Intermediate

This session presents a case study on Sponsor preparation for EU CTR readiness and reflect on path forward for sponsors conducting trials in the EU. It will focus on key issues experienced by sponsors while planning and implementing CTR.

Learning Objectives

Define key regulatory changes as a result of EU CTR; Summarize main issues experienced so far by sponsors; Identify key risks associated with EU CTR and compare different approaches to risk management; Translate cross functional change management tools used in this implementation project for future changes in regulatory landscape.

Chair

Emma Kincaid

Speakers
avatar for Emma Kincaid

Emma Kincaid

Manager, Clinical Trial Excellence, Global Regulatory Affairs Development Strate, Alexion, AstraZeneca Rare Disease, United States
Emma Kincaid is currently Manager, Clinical Trial Excellence, Global Regulatory Affairs at Alexion, AstraZeneca Rare Disease. Emma Kincaid has 5 years of experience working in clinical research. She joined Alexion in 2019 and has since then been motivated to help advance innovative... Read More →

Thursday June 29, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  04: MedAffairs-SciComm, Session