Leadership Roundtable
4 September 2025 @ Microsoft Messeturm Franktfurt, Germany. "Implementing QbD with AI" - a complimentary forum for 40 senior delegates. Request an invitation while seats last.
Accelerate Trials, Stay Inspection-Ready
Boards, regulators, and patients all expect faster studies that never compromise on quality. On 4 September, join Microsoft and Cyntegrity for a high-impact roundtable on how AI-powered Quality-by-Design (QbD) and Risk-Based Quality Management (RBQM) deliver inspection-ready trials without blowing the budget.


Key Take-aways
Trust
Metric framework for Responsible AI in GxP.
Security
Data protection playbook to satisfy GDPR & ICH E6(R3).
ROI
Proven time-to-value from predictive risk signals.

Preliminary Agenda Snapshot
12:00 | Arrival & Networking Lunch
12:30 | Opening - "Why AI-Driven QbD Has Reached the Boardroom"12:40 | Keynote 1 - "Responsible AI in Practice: Trust, Security, & ROI for Clinical Trials"
13:25 | Espresso & Peer Exchange
13:40 | Keynote 2 - "AI-Enabled QbD in Practice: Cycle-Time, Cost-of-Quality, and Inspection Readiness"
14:25 | Case Study - "From Manual Checks to Predictive Quality: How a Sponsor Cut Database-Lock Time by 30% with AI-Augmented RBQM."
14:55 | Executive Panel - "Trust, Validation & Reproducibility: De-Risking AI-Adoption"
15:40 | Interactive Q&A & Next Steps
16:10 | Closing Reception & Skyline Networking (until 17:00)

Speaker Sneak Peek
"Leaders who build inspection-ready trials don't gamble on quality - they engineer it."

Artem Andrianov, PhD
CEO and founder of Cyntegrity,
architect of AI-augmented RBQM
delivering faster, inspection-ready
trials worldwide.
architect of AI-augmented RBQM
delivering faster, inspection-ready
trials worldwide.

Aurelie Dequelson
Head of Risk Surveillance, Aurelie leads
risk-based quality management strategy
and drives its adoption across Novartis' development portfolio.
risk-based quality management strategy
and drives its adoption across Novartis' development portfolio.

Ida Holme, MD
Head of RBQM, Ida brings experience
from previous leadership roles at
Novo Nordisk and holds a
Doctor of Medicine degree.
from previous leadership roles at
Novo Nordisk and holds a
Doctor of Medicine degree.

Johann Proeve, PhD
Former Bayer data-management
leader, now Cyntegrity CSO,
advancing QbD standards
through predictive analytics.
leader, now Cyntegrity CSO,
advancing QbD standards
through predictive analytics.

Shehnaz Vakharia, MRQA
VP, APAC at ADAMAS Consulting,
Shehnaz is a seasoned GxP auditor
who guides sponsors in inspection-ready,
risk-based quality systems.
Shehnaz is a seasoned GxP auditor
who guides sponsors in inspection-ready,
risk-based quality systems.

Andrew Warrington
Microsoft Senior Industry Advisor
guiding responsible AI adoption
for secure, compliant, cloud-driven
clinical research.
guiding responsible AI adoption
for secure, compliant, cloud-driven
clinical research.

Event Details

Date
Thursday, September 4, 2025

Time
12:00 - 17:00 CEST

Format
In-person: Frankfurt, Germany

Cost
Complimentary (incl. lunch, cocktail)
Who Should Attend

VPs / Directors in Clinical Ops, Quality, Digital Transformation & Data Science who plan to embed Responsible AI in study oversight within 12 months.