Inspection Readiness 360

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

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Sponsorship Info

Previous Attendees

Real Connections. Real Conversations. Real Inspections.

Join industry professionals who are driving strategy, building processes, and shaping inspection readiness throughout a product’s lifecycle, including:

Clinical sponsor professionals, including:
- Inspection Readiness
- Trial Master File (TMF) Management
- Clinical Quality
- Clinical Operations
- Document Management
- Quality Assurance / Quality Management
- Clinical Oversight
- Clinical Systems & Technology
- Regulatory Affairs (GCP-focused)
- Compliance & Audit Management
- Risk-Based Quality Management (RBQM)

Clinical Research Sites
Trial Master File Providers
Clinical Quality / GCP Service Providers
Clinical Research Organizations (CROs)

Your Inspection Readiness Advantage

Gain proven strategies, real-world case studies, and actionable tools to strengthen inspection readiness across your teams, processes, and trials through educational sessions and practical takeaways, including:

Embedding a Culture of Continuous Readiness — Align systems, processes, and teams to integrate inspection readiness into daily operations, site relationships, and decision-making across the trial lifecycle.
Transforming Strategy into Action — Apply ICH E6(R3), Quality by Design, and risk-based approaches to create scalable, compliant frameworks that work in real-world settings.
Optimizing Oversight and Systems — Build effective TMF oversight, leverage technology, and use mock inspections to identify gaps, improve workflows, and prepare teams for regulator scrutiny.
Staying Ahead of Regulatory Change — Anticipate global inspection trends, adapt to hybrid and remote models, and strengthen collaboration across sponsors, sites, and vendors.

The 360° Event Experience & Benefits

Maximize your time at Inspection Readiness 360 with unparalleled access to expertise, insights, and connections, including:

Hear from 20+ inspection readiness leaders sharing proven strategies and lessons learned
Gain insights from 5+ clinical sites on real-world inspection readiness implementation
Learn from 4+ in-depth case studies highlighting successful sponsor and site approaches
Participate in 7+ hours of dedicated networking with peers and industry experts
Engage with leading consultants, technology providers, and service partners driving readiness innovation
Walk away with tangible strategies and best practices to strengthen your inspection readiness program
Join interactive panel discussions and engaging breakout sessions for practical, actionable learning
Discover ICH E6(R3)-aligned frameworks to improve compliance across your trials
Build lasting relationships that support your readiness journey year-round

Rebecca Bichard

Director, Clinical Process Excellence and Training

Ashley Cafasso

Associate Director, Audit Management

Priya Chaturvedi

Vice President, Head of Global Clinical Quality, GCQA, GCQM and Global Process & Standards

Eisai

Soyoung Chong

Principal Quality Lead

Grace Crawford

Executive Director, Clinical Operations Quality & Learning

Maureen Cunningham

Senior Director

Vinay Edwin

Director, Clinical Quality Lead

Kathleen Frenia Cohen, PharmD

Senior Vice President, Clinical Development Operations

Monika Joshi

Endowed Professor in Cancer Clinical Investigation

Penn State

Aryn Knight

Associate Vice President, Clinical Research,

Dawn Lundin

Vice President, Global Quality Executive Leader

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

Sarah Zrout

Director, Research & Development Quality

Andre Morais Campos

Senior Vice President, Global Clinical Operations

ILiAD Biotechnology

7:45am

Registration Opens and Networking Breakfast

8:45am

Opening Remarks

Join our conference chairs set the tone for the next two days of interactive networking and learning

9:00am

Align Processes and Systems to Build a Culture of Inspection Readiness

Discover how to align systems, processes, and cross-functional teams to embed inspection readiness into daily operations and build a culture of proactive compliance.

Priya Chaturvedi

Global Vice President, Clinical Quality Assurance

Eisai

9:45am

Drive Real Change for ICH E6(R3): Going from Strategy to Actually Adaptation

Explore how AstraZeneca is turning ICH E6(R3) strategy into real-world operational change, with practical insights on site readiness, cross-functional adaptation, and embedding compliance at every level.

Grace Crawford

Executive Director, Clinical Operations Quality & Learning

AstraZeneca

10:30am

Beyond the Noise: Identify Real Risk to Protect Your Trial

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.

Lorenna Sadowski

Senior Director, RDQ GCP Inspection Management

Bristol Myers Squibb

11:15am

Networking Break

11:45am

Clinical Leaders Panel: Embedding Compliance into Clinical Operations Decision-Making as a Foundation for Inspection Readiness

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.

Andre Morais Campos

Senior Vice President, Global Clinical Operations

ILiAD Biotechnology