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Thursday, June 22 • 10:45am - 11:45am
#411: Evolving Clinical Trial Guidance and Regulations: Am I Ready?

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Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will include an overview of the ICH E6 addendum and EU Clinical Trial Regulation 536/2014 and a practical demonstration of how to perform an impact assessment to existing processes and procedures.

Learning Objectives

Describe the changes and assess the impact to existing procedures and processes

Chair

Liz Wool, BSN

Speaker

ICH GCP E6 R2 Addendum Overview and Impact Assessment
Liz Wool, BSN

EU Clinical Trial Regulation 536/2014 Overview and Impact Assessment
Mary Mills, RN


Moderators
avatar for Liz Wool

Liz Wool

Global Head of Training, Barnett International
Liz Wool CCRA, CID, CMT, is Global Head of Training, Barnett International, an education, training and consulting company. Liz possesses 27 years in the product development industry and 39 years in the healthcare industry. Liz's expertise is in clinical research operations, GCP compliance... Read More →

Speakers
MM

Mary Mills

President, Mary Mills & Associates, LLC
Mary Mills has over 30 years’ experience in the Pharmaceutical Industry. Mary works with companies as a nursing consultant & educator. Experience includes PM, CRA, and CRC In recent years, she has been involved as a PM for several of the largest international risk-based clinical... Read More →

Thursday June 22, 2017 10:45am - 11:45am CDT
S405b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  09: TranslSci-Preclin-Clin-ProdDev, Session