Recorded Webinar: Following our successful webinar ‘Remote Monitoring and Preparing for ICH-GCP E6(R2) at Investigator Sites’, many participants are requesting an additional session to address questions in preparing for future GCP audits and inspections conducted in accordance with these revised guidelines. In this webinar, Andrew Mitchell from Intralinks and Dan Sfera from The Clinical Trials Guru in this upcoming webinar as they address these questions submitted by you. This webinar will also features guest speaker Gunnar Danielsson - independent consultant and a retired GCP Inspector with over a decade of experience conducting countless inspections on behalf of the Swedish Medicines Agency and the European Medicines Agency. View this webinar here: http://register.xtalks.com/17q015intralinks

1. 1
ICH-GCP E6(R2)
Q&A WITH INSPECTOR AND SITE VIEWS
Andrew Mitchell, Director of Life Sciences, Synchronoss Enterprise
Gunnar Danielsson, Owner, DGD Consulting
Dan Sfera, Site Owner & Clinical Evangelist
15 March 2017

2. 22
6TH DECEMBER 2017
INTRALINKS HOLDINGS INC. ACQUIRED BY
SYNCHRONOSS TECHNOLOGIES

3. 3
TOPICS COVERED
ICH-GCP E6(R2) Discussion
INTRODUCTION &
BACKGROUND
• Rationale behind
addendum
• Objective
• Implementation
EXPECTATIONS
FOR INDUSTRY
OVERSIGHT,
QUALITY & RISK
MANAGEMENT
TRAINING &
INSPECTION
PREPARATION
LIVE AUDIENCE QUESTIONS

4. 44
ICH E6(R2) Addendum
INTRODUCTION &
BACKGROUND
http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html#6-2
ICH E6(R2) Expert Working Group, Feb 2017

5. 5
ICH E6(R2) EXPERT WORKING GROUP, FEB 2017
Rationale behind the changes
 Since 1996 adoption of ICH E6 GCP, clinical trials have evolved substantially.
 Increases in globalization, study complexity, and technological capabilities.
 Approach to Good Clinical Practice (GCP) needs modernization to keep pace with
the scale and complexity of clinical trials and to ensure appropriate use of
technology
 ICH E6 gave sponsors flexibility to implement innovative approaches – but has
been misinterpreted and implemented in ways that impede innovation
− For example, emphasizing less important aspects of trials (such as focusing on the
completeness and accuracy of every piece of data) at the expense of critical
aspects (such as carefully managing risks to the integrity of key outcome data)
 Modernizing ICH E6 by supplementing it with additional recommendations will
better facilitate broad and consistent international implementation of new
methodologies

6. 6
ICH E6(R2) EXPERT WORKING GROUP, FEB 2017
Objective
ICH E6(R1) has been amended to encourage implementation of improved
and more efficient approaches to clinical trial design, conduct, oversight,
recording, and reporting while continuing to ensure human subject protection
and reliability of trial results

7. 7
ICH E6(R2) EXPERT WORKING GROUP, FEB 2017
Implementation
This ICH GCP Guideline Integrated Addendum provides a unified standard for
the European Union, Japan, the United States, Canada, and Switzerland to
facilitate the mutual acceptance of data from clinical trials by the regulatory
authorities in these jurisdictions

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