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Tuesday, June 26 • 4:15pm - 5:15pm
#293: Medical Monitoring in Non-Interventional Studies: Need for Medical Leadership and Study Primary Care Management

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-620-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will describe and compare in details the role of the medical monitor in the use of non-interventional studies (NIS) versus explanatory clinical trials from the preparation to the end of the study and provide best practices and desirable profile for the medical monitor. We will explore the challenges of the implementation of a solid medical monitoring to conduct the NIS in an optimal way.

Learning Objectives

Compare the roles of a medical monitor in non-interventional post-authorization studies versus clinical trials in pre-approval setting; Discuss needs and best profile for the position.

Chair

Xavier Fournie, MD

Speaker

Perspective of a Pharmacoepidemiologist Involved in Study Design and Analysis of Data
Margaret Richards

Medical Monitoring in Non-Interventional Studies: Need for Medical Leadership and Study Primary Care Management
Xavier Fournie, MD


Speakers
avatar for Xavier Fournie

Xavier Fournie

Corporate Medical Director, Medical Affairs, ICON Plc
Dr. Fournie leads ICO Medical Affairs, providing medical expertise in support of operational strategy and execution. He engages in Medical Monitoring and specific Consulting opportunities. He hold various leadership posts in Late-phase research over 32 years, practiced as a GP and... Read More →
avatar for Margaret Richards

Margaret Richards

Executive Director, Scientific Affairs, Real-World Solutions, PRA Health Sciences
Dr. Meg Richards has over 25 years' experience as an epidemiologist in the public health, biopharmaceutical, and contract research sectors. Prior to joining PRA as Executive Director of Scientific Affairs, Dr. Richards worked for 8 years at Mapi (ICON plc) and PPD-Evidera. Dr. Richards... Read More →

Tuesday June 26, 2018 4:15pm - 5:15pm
Room 257AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  12: Value-Access, Session