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Wednesday, June 22 • 4:15pm - 5:15pm
#374: Around the World: Regulator Perspectives on Decentralized Clinical Trials

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-642-L04-P ; CME 1.00; RN 1.00

Let’s take a tour around the world to discuss with regulators their guidance on decentralized aspects of clinical trials. Some health authorities have released their guidance and more expected soon. In this session we can learn more about this!

Learning Objectives

Describe regulator perspectives on decentralized aspects of clinical trials; Discuss the similarities and differences in the decentralized clinical trials guidance documents released by regulators around the world and/or programs on this topic within the regulatory agency.

Chair

Lina AlJuburi, PharmD, MSc

Speaker

FDA Perspective
Leonard Sacks, MD

NoMA Perspective
Anja Schiel, PhD

Industry Efforts: Decentralized Clinical Trials
Leslie Harden, PharmD



Speakers
LH

Leslie Harden

Director, Science and Regulatory Team, Biotechnology Innovation Organization (BIO), United States
LH

Leslie Harden

Director, Science and Regulatory Team, Biotechnology Innovation Organization (BIO), United States
avatar for Leonard Sacks

Leonard Sacks

Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA, United States
Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently... Read More →
avatar for Anja Schiel

Anja Schiel

Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA, Norwegian Medicines Agency (NoMA), Norway
Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc before starting at the Norwegian Medicines Agency (NoMA) in 2012. At NoMA she is working as... Read More →


Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Session