New ICH E6(R3) GCP Guideline MasterClass - US edition
21-22 February, 2024
Adoption of New Critical to Quality Requirements
The current guideline at the time was outdated. Now with the revision of a clear connection to ICH E8 “General Considerations for Clinical Trials” guideline, there is a clear pathway to focusing on what matters and more freedom in trial design.
21-22 February, 2024, Virtual
Time Zone: Eastern Standard Time (EST) / UTC−05:00
Overview
The ICH E6(R2) revision was the beginning of global harmonization and the modernization of clinical trials, but it lacked a link to support for clinical trial design flexibility. The current guideline at the time was outdated. Now with the revision of a clear connection to ICH E8 “General Considerations for Clinical Trials” guideline, there is a clear pathway to focusing on what matters and more freedom in trial design. The ICH E6(R3) Good Clinical Practice (GCP) guideline incorporates key concepts from the revised ICH E8(R1) Guideline and expands on the themes of Quality by Design, not using a one size fits all approach, and using a least burdensome approach to the design and conduct of clinical trials. Rather than following a checkbox mentality, critical thinking is emphasized. Additional emphasis is on selection and oversight of contract service providers, electronic system validation and security, and the need for maintaining a risk based approach throughout. With this Masterclass, learn how to successfully integrate changes into your organization and programs.
#masterclass #glceurope #pharmaonlinetraining #globalleadingconferences #clinicalprojectmanagement
RECOMMENDATION
Who should attend?
• Anyone involved in clinical trials
• Clinical Research Professionals
• Sponsors
• CROs
• Clinical Sites
• CRAs, Project Managers
• Clinical Operations
• Principal Investigators
• Study Coordinators
• Study Managers
Testimonial
Our success stories
"High attention to detail in course content and very well delivered"
Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom
Our success stories
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland
Our success stories
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany
About GLC
Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.
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