FDAnews Announces — ICH E6 GCP Revisions: The New Standard Webinar, May 9, 2017

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For clinical trial operators, the rules are about to become a lot more complicated. The revision known as ICH E6 (R2) GCP will impose new requirements to use advanced technology, force changes in trial design, conduct, oversight, recording and reporting and all the while, continue insisting on highest standards of human protection and data integrity.

FDAnews

FDAnews

ICH E6 GCP Revisions: The New Standard
**An FDAnews Webinar**
May 9, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/iche6                

For clinical trial operators, the rules are about to become a lot more complicated.

A lot costlier too.

The revision known as ICH E6 (R2) GCP will impose new requirements to use advanced technology, force changes in trial design, conduct, oversight, recording and reporting and all the while, continue insisting on highest standards of human protection and data integrity.

And that’s not all. Standards regarding electronic records and essential documents to boost trial quality also are being updated.

Sign up now for a special event from FDAnews, a webinar with a pro to translate technicalese into plain English and guide manufacturers toward full compliance.

Dr. Susan Leister, Director-QA at Technical Resources International, is a recognized authority on achieving and maintaining quality in clinical trials. She is ASQ-certified as a CQA and a CSSBB, and served as a judge in the 2013 ASQ International Team Excellence Awards.

At the end of 90 fast-paced minutes, attendees will have mastered:

  •     Major changes set forth under ICH E6 (R2) GCP
  •     Potential challenges to compliance
  •     Impact of compliance changes
  •     How to implement the changes most efficiently and with least disruption
  •     Unification of multiple countries — including EU member nations, Japan, Canada and Switzerland — for approval
  •     And much more!

Meet the Presenter:
Dr. Susan Leister, Director of Quality Assurance, Technical Resources International
Dr. Leister has over 20 years of industry experience. In addition she has been a faculty member of the University of Phoenix Undergraduate and Graduate School of Business for over eight years. She holds certifications from ASQ as a CQA and a CSSBB. She serves as the Section Chair for ASQ Section 509 and served for several years as a Maryland Performance Excellence Award Examiner.

Who Will Benefit:

  •     Medical Affairs Officers
  •     Director of Clinical Operations
  •     Regulatory Affairs Professionals
  •     Director of Publications
  •     Director of Clinical Trial Regulatory Management
  •     Clinical Trial Information Disclosure Directors
  •     Global Clinical Safety and Pharmacovigilance Officers
  •     Compliance Staff
  •     Clinical Quality Auditors
  •     Quality Assurance Personnel

Webinar Details:
ICH E6 GCP Revisions: The New Standard
**An FDAnews Webinar**
May 9, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/iche6

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/iche6                                        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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