Webinar Date & Time
10 September 2025 from 04:00 PM to 05:30 PM (CEST)
Webinar Overview
The International Council for Harmonisation (ICH) released a revision of its Good Clinical Practice guideline—E6(R3). This update introduces changes with a strong focus on quality by design, critical thinking, and risk-based approaches throughout the clinical trial lifecycle.
This webinar is designed specifically for Clinical Research Associates (CRAs) and will explore how the upcoming E6(R3) revision will impact the CRA role in practice. We’ll cover what’s new, what’s changing, and what this means for monitoring activities, sponsor oversight, and interactions with sites.
Topics will include:
- Reason for the revision
- Key concepts introduced in ICH E6(R3) and main changes
- CRA’s role in Clinical Trials
- How quality by design and risk-proportionate approaches affect CRA responsibilities
- Enhancing CRA contributions to data quality and participant safety
- Shifting from checklist-based monitoring to critical thinking and risk-focused oversight
- Supporting investigator sites in building and sustaining a quality culture
- Preparing for the change: what CRAs can do now
The presentation will be followed by a live Q&A session to discuss practical scenarios, clarify common questions, and share experiences from the field.
Presenter
Maria Veleva, MD
Founder of Velev Consulting Ltd.
Maria Veleva, MD, is the Founder of Velev Consulting Ltd., a clinical quality consultancy supporting life science companies with tailored solutions to enhance trial quality and operational effectiveness. She brings over 20 years of experience in global clinical research and began her career as a Clinical Research Associate (CRA), gaining hands-on insight into trial execution and site engagement.
Maria went on to hold several leadership roles at IQVIA, including Director of Quality Management for Key Market European countries. In this role, she led cross-functional quality initiatives, supported global inspection readiness, and developed training and lessons learned programs for operational teams worldwide. She was also an active contributor to global SOP and policy development as part of IQVIA’s Quality Management Board.
Maria holds a Medical Doctor’s degree from Sofia Medical University and is a certified Lean Six Sigma professional. She is a sought-after speaker and trainer, regularly delivering presentations at international conferences. She currently serves as Chair of the Consultant Special Interest Group at the Research Quality Association (RQA) and Co-Chair of the Quality Working Party at European Forum for Good Clinical Practice (EFGCP). Maria is also a member of the Society of Quality Assurance (SQA) and the Bulgarian Association of Clinical Research (BACR). Committed to knowledge-sharing, Maria delivers training, mentors professionals across the industry, and provides pro bono career guidance via LinkedIn.
Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
09 September 2025 at 6 p.m.
How to register?
1) Go on the REGISTRATION PAGE and click on the orange button “GET TICKETS”
2) Check your order and click on the green “CHECKOUT” button
3) Fill in all the necessary information and validate your order
Confirmation
You will receive 2 confirmation emails:
A) One from Eventbrite with your invoice
B) One from “Eucrof” with all the necessary information to connect the D-Day!
Questions?
Should you have any questions about registration, invoices or connection, do not hesitate and contact us by email at webinar@eucrof.eu
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