ICH E6 R2 - Webinar Recording/Transcript
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.