Beyond Clinical Compliance - May 12-13, 2026
Risk, Quality and Innovation in the R3 Era
Clinical research is evolving—and so are the expectations for compliance. Beyond Clinical Compliance is a working conference for quality, operations, and compliance professionals who are ready to think differently about risk, oversight, and inspection readiness in the era of ICH E6(R3).
Session Topics Include:
CHAMPIONS OF QUALITY
They Built the Culture Behind Compliance: How Quality Leaders Create Environments Where the Right Decisions Actually Happen
RISK TRIAGE IN COMPLEX TRIALS
When Everything Looks Like Risk: How Clinical Quality Teams Can Triage Oversight in Complex Trials
SUPPLIER QUALIFICATION
Peeling Back the Layers: How Risk-Based Supplier Qualification is Changing Clinical Oversight
CROSS FUNCTIONAL OVERSIGHT
When Everyone Owns the Risk, No One Does: The Reality of Cross-Functional Oversight
AI AND INNOVATION RISKS
Leveraging Innovative Technologies to Drive Efficiency Without Creating New Compliance Risks
SCALING CLINICAL OVERSIGHT AND SUPPORT
Your Team Can’t Do Everything: How Leaders are Expanding Expertise Without Slowing Trials
AVOIDING THE INSPECTION SCRAMBLE
Stop Fixing Problems Right Before Submission: Building Inspection Readiness Earlier
GCP INSPECTION GOSSIP
What Teams Have Experienced During Recent Inspections—and How They Are Adapting in a Time of Change
INSIDE THE CLINICAL TRIAL
What the Patient Experience Reveals About Trust, Communication, and Trial Design
INTERACTIVE: OPERATIONALIZING RBQM
How Do YOU Decide What Actually Deserves Oversight?
BRIDGING THE OVERSIGHT GAP
When Oversight Breaks Down: Real Scenarios That Test Operational and Quality Alignment
Featured Speakers
Reetu Dandora, SVP, Quality & Regulatory Compliance, AVEO ONCOLOGY
Teresa DeVincentis, Quality Head, SOLID BIOSCIENCES
Donna Dorozinsky, Founder & CEO, JUST IN TIME GCP
Gaby Graterol, Associate Director, Clinical QA, ASTELLAS
MyLe Hoang, Head of North America and EU Clinical Quality Assurance, EISAI
Daniel Khordi, Executive Director, MRL Quality Assurance, MERCK
Kate Korson, Clinical Trial Participant; Patient Advocate, PENN MEDICINE
Maryann Livolsi, Senior Director, GCP Quality Assurance, BILL AND MELINDA GATES RESEARCH FOUNDATION
Bill McDonald, Quality Business Partner, Data & Digital, R&D Quality & Risk Management, GSK
Olga Rostovtseva, Associate Director, GxP Quality, AMGEN
Abby Statler, PhD, Senior Director, Clinical Quality Assurance, AVEO ONCOLOGY
Ruth Ann Subach, PharmD, BCMAS, Vice President, Clinical Development & Operations, FUJIFILM PHARMACEUTICALS U.S.A., INC.
Melissa Suprin, Head, Risk-Based Quality Management, BEONE MEDICINES
Stefan van den Akker, Head of R&D Quality Risk Management, ACADIA PHARMACEUTICALS
Wil Vickroy, Clinical Research Nurse, UNIVERSITY OF PENNSYLVANIA
2026 Lead Sponsor
Pricing and Location
Designed for the In-Person Experience
The in-person experience is where you’ll gain the most value—through real conversations, shared experiences, and meaningful connection.
In-Person Registration Includes
- Two days out of the office to be face to face with like-minded peers and walk through common challenges, leaving you inspired and motivated to take action and make change.
- In-Person access to all sessions and presentations listed in agenda
- PDF versions of all slides presented, pending speaker approval
- Your choice of roundtable discussion
- Optional post-conference workshop on Risk-Proportionate Oversight
- All networking breaks and Booze and Schmooze/Mock and Talk Reception
- Breakfast, lunch and ample snacks and beverages for the duration of the conference
- Access to the conference portal for pre, during, and post event engagement with entire audience (both in-person and virtual)
- On-demand access to the live-streamed sessions via the conference app
Stay Connected, Even if you Can't Be in the Room
Join selected live-streamed discussions to engage with speakers, and stay part of the conversation, with the flexibility to revisit key sessions on demand.
Virtual Registration Includes
- Live-stream access to select main stage sessions on May 12
- Real-time participation in Q&A and chat during live-streamed sessions
- On-demand access to all streamed sessions via the conference portal after the event
- Access to the conference portal for pre-, during-, and post-event engagement with the full audience (in-person and virtual)
- Downloadable session slides (PDFs) from streamed presentations, pending speaker approval
CYTO | PHL inside the Cira Centre
Connected to 30th Street Station and a parking garage, CYTO | PHL is easy to get to and offers a modern life-science themed Philadelphia event space with many windows and a flexible design, ideal for meaningful engagement.
CYTO | PHL
Cira Centre, 2929 Arch Suite 250,
Philadelphia, PA 19104