FDAnews Announces — New Management Report — Good Clinical Practices: The New ICH E6 Standard
Falls Church, VA (PRWEB) July 26, 2017 -- Good Clinical Practices:
The New ICH E6 Standard
**An FDAnews Management Report**
http://www.fdanews.com/products/54449-good-clinical-practices
Many clinical trial operators are struggling to master the complexities of the revised ICH E6.
The revision to ICH E6 Good Clinical Practices imposes new guidelines to use advanced technology, creating 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. Guidelines regarding electronic records and essential documents to boost trial quality also are being updated.
Good Clinical Practices: The New ICH E6 Standard outlines the changes in the guideline and offers suggestions for implementing new requirements. Readers will learn about:
• New definitions or enhancements to existing glossary terms
• How information should be recorded, handled and stored
• Clinical investigators’ qualification requirements, supervision responsibilities, record keeping and reporting
• How to provide training and adequate resources to maintain quality management and risk management
• An increased focus on risk-based monitoring
• And much more.
Good Clinical Practices: The New ICH E6 Standard gives readers an understanding of how the evolution of technology has changed the focus of Good Clinical Practices and how to keep up with the changes.
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
FDAnews Management Report Details:
Good Clinical Practices:
The New ICH E6 Standard
Price: $397
http://www.fdanews.com/products/54449-good-clinical-practices
Easy Ways to Order:
Online: http://www.fdanews.com/products/54449-good-clinical-practices
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.
Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]
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