New Jersey Chapter: ICH E6(R3) Unpacked: Leveraging Compliance to Deliver Quality Outcomes
Event Description:
When it comes to ICH E6(R3), clarity doesn’t come from reading the guideline alone — it comes from understanding what it means in the context of real roles, responsibilities, and collaboration. In this 90-minute interactive session, clinical investigator site teams and sponsor organizations will examine key concepts side by side, uncovering where responsibilities overlap and how working together can drive efficiency leading to quality outcomes.
Through case examples and discussion, we’ll explore sections of the guideline with significant operational impact — including Quality by Design, Critical to Quality factors, risk-proportionate oversight, and data governance. Participants will receive targeted example questions designed to help assess where their organization stands and identify meaningful next steps for implementation.
By translating regulatory expectations into shared understanding, we’ll highlight how joint interpretation can lead to stronger results than unpacking it alone.
Speaker:
Leslie Sam
Event Agenda:
5:45 - 6:00 : Sign in
6:00 - 7:30 : Presentation
7:30 - 7:45 : Q&A
Learning Objectives:
By the end of this session, participants will be able to:
- Break down key ICH E6(R3) updates to clarify shared and distinct responsibilities across sponsor and site roles
- Reflect on how aligned interpretation of the guideline can reduce misunderstandings and improve implementation
- Examine a range of operational areas — from design to documentation — where collaborative approaches support quality and efficiency
- Use example guided question to assess organizational readiness and identify actionable steps for implementing the guideline
Registration Information:
- Chapter Member: $0
- ACRP Member: $5
- Non-Member: $10
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.
The educational portion of this event may be self-reported as 1.5 points toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.