Suncoast Chapter: Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3) (ACRP Webinar Replay)
This event will be presenting a replay sessions from the ACRP Webinar Library
Event Description:
This 60-minute webinar will help clinical research, regulatory affairs, and Good Clinical Practice quality professionals decode the complexities of the updated guidance. Leslie will break down the key shifts, themes, and differences between R2 and R3, provide real-world examples to simplify the changes, and introduce a framework to help identify gaps and prioritize the next steps for compliance.
Speakers:
Leslie Sam, BA, CSSBB, CQIA President
Learning Objectives:
- Describe the key principles and structural changes introduced in the updated ICH E6 (R3) guidance.
- Differentiate major updates between ICH E6 (R2) and R3 and explain how these changes affect clinical research operations and oversight.
- Interpret real-world examples illustrating how the new guidance applies to clinical trial design, conduct, and quality management.
- Identify potential compliance gaps within their current Good Clinical Practice processes based on the updated guidance.
- Apply a practical framework to prioritize next steps for aligning organizational practices with the new regulatory expectations.
Registration & ACRP Contact Hour Information:
- Chapter Member (registration with or without contact hour): $0
- ACRP Member (registration only): $15
- ACRP Member (registration + contact hour): $30
- Non-Member (registration only): $30
- Non-Member (registration + contact hour): $105
After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer.
To claim contact hours: Register and purchase the contact hours and attend the event. After attending the event, visit learning.acrpnet.org and log into your ACRP account. Click the “GO TO MY COURSES” box. Find the event in your dashboard, confirm your attendance, and take the event evaluation between 1 and 30 days following the event to obtain the online certificate. After 30 days, contact hours are no longer available.