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:
SUPPLIER QUALIFICATION
Peeling Back the Layers: How Risk-Based Supplier Qualification is Changing Clinical Oversight
CROSS FUNCTIONAL OVERSIGHT
Who Owns the Risk? Aligning Clinical Teams on Oversight Decisions Across Functions
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
Featured Speakers
Reetu Dandora, SVP, Quality & Regulatory Compliance, AVEO ONCOLOGY
Donna Dorozinsky, Founder & CEO, JUST IN TIME GCP
Daniel Khordi, Executive Director, MRL Quality Assurance, MERCK
Kate Korson, Clinical Trial Participant; Patient Advocate, PENN MEDICINE
Dawn Lundin, Quality Head; Adjunct Professor
Sharon Reinhard, Clinical Quality and Compliance Thought Leader; Acting Head of Quality for Late Stage Biotechs
Olga Rostovtseva, Associate Director, GxP Quality, AMGEN
Leslie Sam, President, LESLIE SAM AND ASSOCIATES, LLC
Abby Statler, PhD, Senior Director, Clinical Quality Assurance, AVEO ONCOLOGY
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
2026 Lead Sponsor
