January 27-28, 2026
Philadelphia, PA
A Full-Circle Strategy to Aligning Clinical Operations, TMF, and Quality Systems in the Era of ICH E6(R3) Through Process and Systems
Mark Behn
Senior Director, Clinical Systems Quality
Rebecca Bichard
Director, Clinical Process Excellence and Training
Ashley Cafasso
Associate Director, Audit Management
Priya Chaturvedi
Vice President, Head of Global Clinical Quality
Soyoung Chong
Principal Quality Lead
Brandon Clough
Managing Director of Operations - Central Region
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Grace Crawford
Formerly Global Head, Clinical Quality Management
Maureen Cunningham
Senior Director, Clinical Oversight, Systems and Training
Reetu Dandora
Senior Vice President, Quality and Regulatory Compliance
Brian Dean
Vice President, Clinical Operations
Kathleen Frenia Cohen, PharmD
Senior Vice President, Clinical Development Operations
Teresa Gorecki
VP and Practice Director
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Sheila Gwizdak
VP, Consulting
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Monika Joshi
Endowed Professor in Cancer Clinical Investigation
Samelyse Lees
Inspection and Intelligence Lead, Director
Matt Lowery
CEO and Principal Consultant
Andre Morais Campos
Senior Vice President, Global Clinical Operations
Adriana Robinson
Manager, Global TMF
Loreena Sadowski
Senior Director, RDQ GCP Inspection Management
Niloy Shah
Executive Director, Research & Development Quality
Robert Staszewski
Associate Director, Clinical Oversight & Systems
Jamie Marie Toth
Senior Director Trial Master File Management & Records
David Vulcano, LCSW, MBA, CIP, RAC, FACRP
Vice President, Clinical Research Compliance & Integrity
Nancy Wintering, LCSW, CCRP
Assistant Director
Judyth Zahora, PMP
Executive Director, Quality Assurance
Sarah Zrout
Director, Research & Development Quality
Join our conference chair set the tone for the next two days of interactive networking and learning.
Discover how to align systems, processes, and cross-functional teams to embed inspection readiness into daily operations and build a culture of proactive compliance.
Driving Real Change for ICH E6 (R3) through Transforming Strategy into Practical Implementation for Inspection-Ready Clinical Teams
Cut through the noise to identify the risks that truly matter—learn how to prioritize compliance efforts, protect trial integrity, and prepare sites for what regulators actually scrutinize.
Join clinical operations leaders from all size organizations as they share how inspection readiness is embedded into daily decision-making—from trial design through closeout—while balancing quality, timelines, and cross-functional collaboration.
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Hear directly from clinical research site leaders on how they’re empowering staff, optimizing systems, and strengthening sponsor partnerships to proactively drive site-level inspection readiness and quality.
Explore a real-world case study showing how one sponsor transformed site relationships by shifting from audit-focused oversight to a collaborative, metrics-driven model that fosters trust, transparency, and lasting inspection readiness.
Discover how strategic mock inspections and real-time readiness planning transformed global sponsor and site inspections—culminating in a successful live FDA inspection through proactive coaching, streamlined document management, and cross-team alignment.
Join our conference chair to recap yesterday and set the stage for day 2 events.
Discover how one team rebuilt a resilient inspection readiness framework after a challenging inspection—leveraging QRBMs, optimized SOPs, and cross-functional oversight to drive continuous improvement and regulatory success.
Join this expert panel as they explore how to stay “inspection steady” in an ICH E6(R3) world by leveraging systems, technology, and streamlined processes to ensure continuous readiness across sponsors, sites, and vendors.
Explore a case study on managing multiple global inspections through a structured, programmatic approach—highlighting how clearly defined roles, streamlined processes, and vendor coordination drove inspection success.
This session will help quality, operations, and compliance leaders understand how to activate inspection readiness practices into focused preparation steps once an inspection is imminent — ensuring that readiness translates into smooth, confident execution under real-time scrutiny.
Discover how one team rebuilt a resilient inspection readiness framework after a challenging inspection—leveraging QRBMs, optimized SOPs, and cross-functional oversight to drive continuous improvement and regulatory success.
TWO COMMERCE SQUARE
2001 Market Street, Philadelphia, PA 19103
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