ICH E6 GCP Revisions
The New Standard

Tuesday, May 9, 2017 · 1:30 p.m. - 3:00 p.m. EDT

Every clinical trial operator will feel the impact of the major revision of the ICH E6.  

The revision, known as ICH E6 (R2) GCP, will impose new requirements to use state-of-the-art 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 just for openers. Also slated for updating: Standards regarding electronic records and essential documents to boost trial quality.

As with all such documents, the requirements are complex and technical. Yet failure to understand and comply risks the wrath of regulators from the U.S. FDA to the Japanese Ministry of Health, Labor, and Welfare (MHLW).

FDAnews has retained the services of an expert to help you understand, and comply with, this major change to clinical trial conduct.

In an information-packed 90-minute Web-based presentation, Dr. Susan Leister will help you master:

  • Major changes set forth under ICH E6 (R2) GCP

  • Potential challenges to compliance

  • Impact of compliance changes on your organization

  • 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!

Dr. 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.

Injury or harm to trial subjects is a sure path to multimillion-dollar lawsuits ... or worse. Isn’t it worth 90 minutes of your time to protect yourself and your organization? Register now.

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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



Meet Your 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.

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