ICH E6 R2 - Webinar Recording/Transcript

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ICH E6 R2: Integrating the New Standard and What You Really Need to Know to Comply

The ICH E6 R2 GCP guideline has major impact on everyone from clinical trial principal investigators to drug and biologics makers. But a year after its promulgation, clinical trials professionals still struggle with its provisions.

The quality management requirement of Sec. 5 and the risk management provisions, are particularly troublesome — so much so that FDAnews has called on an expert to clear things up.

Join us for an informative presentation from FDAnews featuring Dr. Susan Leister, a leader in quality control matters. In just 90 minutes, she’ll address your most pressing questions and set you on a path to full compliance. She’ll cover:

  • Major changes in Sec. 5.0 and how they may affect you
  • Specific challenge areas: sponsor quality management system, software validation, risk management
  • The hidden implications of certain Sec. 5.0 changes
  • A path to full and effective compliance
  • And much more

This presentation delivers an immediate payoff in smoother compliance, greater efficiencies, and swifter FDA approvals even. You miss it at your peril.

  • Medical Affairs
  • Clinical Operations
  • Regulatory Affairs/Compliance
  • Publications Directors
  • Clinical Trial Regulatory Management
  • Clinical Trial Information Disclosure
  • Global Clinical Safety and Pharmacovigilance
  • Clinical Quality Auditors
  • QA/QR/QC

Dr. Susan Leister, Director-Quality Assurance for Technical Resources International, boasts more than 20 years of industry experience. She holds ASQ certifications as a CQA and a CSSBB; serves on the ASQ Section 509 Executive Committee as the Section Chair; and served as a Maryland Performance Excellence Award Examiner for four years. She teaches in the University of Phoenix Undergraduate and Graduate School of Business.