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

Ashley Cafasso

Associate Director, Audit Management

Soyoung Chong

Principal Quality Lead

Priya Chaturvedi

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

Eisai

Grace Crawford

Executive Director, Clinical Operations Quality & Learning

Maureen Cunningham

Senior Director

Vinay Edwin

Director, Clinical Quality Lead

Aryn Knight

Associate Vice President, Clinical Research,

Matt Lowery

Clinical Research & Site Expert

Dawn Lundin

Vice President, Global Quality Executive Leader

Lykos Tx

Monika Joshi

Endowed Professor in Cancer Clinical Investigation

Penn State

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

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.

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.

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.

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.

12:45pm

Networking Lunch

1:15pm

Site-Level Inspection Readiness: Empowering Teams, Systems, and Standards to Ensure High Quality and Impactful Sponsor/ Site Relationship

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.

2:15pm

CASE STUDY: Impacting a Site to Maintain Inspection Readiness

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.

3:00pm

Networking Break

3:30pm

Case Study: Utilizing Mock Inspections to Impact Global Sponsor and Site Inspections

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.

4:15pm

Adapt to a Modernized GCP Framework

Gain practical insights into how sponsors and sites are adapting to ICH E6(R3) by embedding risk-based quality, real-time oversight, and proactive inspection readiness across teams, systems, and trial processes.

5:00pm

Day One Concludes

5:15pm

Cocktail Reception

10:00AM

7:45am

Registration Opens and Networking Breakfast

8:45am

Day 2 Opening Remarks

9:00am

Align Processes, Systems & Teams for Ongoing Inspection Readiness

Learn how to align systems, processes, and cross-functional teams to build a scalable, tech-enabled inspection readiness program that supports continuous compliance across the clinical lifecycle.

9:45am

CASE STUDY: Building a Resilient Inspection Readiness Framework

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.

10:30am

CASE STUDY: Managing Global Inspections Through a Programmatic Approach to Roles, Process, and Readiness

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.

11:15am

Networking Break

11:45am

Inspection Steady Panel : Staying Ready Through Systems, Technology & Processes in an R3 World

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.

12:45pm

Networking Lunch

1:15pm

Innovative quality by design approaches to support regulatory compliance and Inspection Readiness

Explore how innovative Quality by Design (QbD) approaches are being used to embed compliance, enhance cross-functional collaboration, and drive inspection readiness across the clinical development lifecycle.

2:15pm

Build a TMF Oversight Framework That Works

Discover how to combine technology, structured oversight, and thoughtful process design to build a scalable, inspection-ready TMF strategy—with real-time dashboards, team ownership, and compliance-driven workflows.

3:00pm

Networking Break

3:30pm

TMF Mock Inspections: Stress Testing Your Systems Before the Regulators Do

Uncover how TMF mock inspections can stress test your systems, reveal critical gaps, and prepare your team for regulatory scrutiny—through realistic simulations, compliance-aligned checklists, and actionable findings.

4:15pm

Panel: The Future of Inspection Readiness and the Global Inspection Landscape

Uncover how global regulators, evolving technologies, and hybrid inspection models are reshaping the future of inspection readiness—and what sponsors and sites must do to stay ahead in a rapidly changing landscape.

"Overall I feel that the summit was engaging and a wonderful opportunity to network and meet other TLLs"

TLL A.D. of Product Strategy

Incyte

"TLL provided additional, tools, strategy and network"

TLL

Alexion

"This summit was informative and helpful to me in order to perform my day to day TLL functions"

Associate Director, US Product Strategy: TLL

Incyte

"Pleasantly Surprised"

Associate Director & US Strategy

Incyte

"Very applicable & Informative"

TLL

Kyowa Kirin

"Focused on our unique role"

TLL

Sobi

Frequently Asked Questions

1. Why Should I Attend? (aka: What's In It for Me?)
TOP REASONS TO ATTEND
- Learn how to build a proactive and sustainable readiness model from study start-up through close-out—not just fire drills before an audit.
- Understand how Clinical Ops, QA, Regulatory, Data Management, and other key stakeholders collaborate to ensure inspection success from start up
- Hear directly from sponsors on how they have navigated FDA, EMA, and MHRA inspections
- Explore digital tools that streamline TMF management, audit trail capture, issue tracking, and site inspection preparedness.
- Participate in hands-on sessions and peer-to-peer discussions that provide actionable frameworks to impact your inspection readiness process
- Learn how to secure internal buy-in and drive a culture of compliance and
- Accountability across teams and geographies.
- Network and learn with clinical leaders to ensure you are Inspection Ready All Year Round
2. Who Should Attend? (Hint: It Might Be You)
This event is designed for pharmaceutical, biotech, and medical device professionals with responsibilities in the following areas:
- Inspection Readiness
- Clinical Operations
- GCP/ Quality
- Trial Master File
- Document Management
- Clinical management
- Regulatory affairs
3. Can I Register a Group? (Squad Goals: Activated)

Yes! Bring your crew. Whether it’s your department, your leadership team, or your whole company — group registration is easy and comes with perks. Discounts? You bet. Better collaboration back at the office? Definitely. Reach out to us for custom group packages and let’s make it a team experience.

Interested in Group Rates?

Email Solange Leclair at Solange@momentumevents.com to secure the best group discounts
4. What’s the Event About? (The Elevator Pitch)

Inspection readiness is the preparedness for a clinical inspection of a clinical trial which is focused on the documentation, process, systems, and compliance. These inspections are conducted by regulatory agencies such as the FDA, EMA, MHRA, and other global regulatory authorities. Inspections make sure a trial is being compliance with GCP and can lead to a warning letter, approval delays, and rejections of clinical data.

Inspections also have a focus on data integrity as well as patient safety and operational excellence. Not just clinical quality or inspection readiness professionals are responsible for an inspection, but it;s a cross-functional effort to ensure a trial can withstand regulatory scrutiny. Due to this all departments involved in clinical research need to take Inspection Readiness into mind when setting up study start up’s, when setting a document/ TMF process, and with all SOP’s with vendors.
5. Interested in Sponsorship? (Let’s Talk Visibility + Value)

Want your brand in front of the right people, in the right way, at the right time? Our sponsorship opportunities are customizable, creative, and designed to deliver ROI. From thought leadership to branding to curated meetings — let’s create something impactful. Drop us a line and we’ll cook up something special.

2026 SPONSORSHIP OPPORTUNITIES ARE NOW OPEN

Sponsorship is a great way to enhance your brand’s visibility and help you connect with top-level decision-makers, innovators, and industry disruptors. There are a number of ways to maximize branding opportunities at the summit.
6. How Do I Network? (Spoiler: It’s Easier Than You Think)

Inspection Readiness 360

January 27-28, 2026

Philadelphia, PA

Previous Attendees

Real Connections. Real Conversations. Real Inspections.

Your Inspection Readiness Advantage

The 360° Event Experience & Benefits

Featured Speakers

Meet the inspection readiness leaders making an impact!

Ashley Cafasso

Soyoung Chong

Priya Chaturvedi

Grace Crawford

Maureen Cunningham

Vinay Edwin

Aryn Knight

Matt Lowery

Dawn Lundin

Monika Joshi

Loreena Sadowski

Niloy Shah

Robert Staszewski

Jamie Marie Toth

Interested in Becoming Part of the Speaking Faculty?

Program Agenda: Day One

January 27, 2026 (All times are in EST)

7:45am

Registration Opens and Networking Breakfast

8:45am

Opening Remarks

9:00am

Align Processes and Systems to Build a Culture of Inspection Readiness

9:45am

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

10:30am

Beyond the Noise: Identify Real Risk to Protect Your Trial

11:15am

Networking Break

11:45am

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

12:45pm

Networking Lunch

1:15pm

Site-Level Inspection Readiness: Empowering Teams, Systems, and Standards to Ensure High Quality and Impactful Sponsor/ Site Relationship

2:15pm

CASE STUDY: Impacting a Site to Maintain Inspection Readiness

3:00pm

Networking Break

3:30pm

Case Study: Utilizing Mock Inspections to Impact Global Sponsor and Site Inspections

4:15pm

Adapt to a Modernized GCP Framework

5:00pm

Day One Concludes

5:15pm

Cocktail Reception

Program Agenda: Day One

October 13th

10:00AM

Welcome

10:00AM

Welcome

10:00AM

Welcome

10:00AM

Welcome

10:00AM

Welcome

10:00AM

Welcome

10:00AM

Welcome

10:00AM

Welcome

Program Agenda: Day Two

January 28, 2026

7:45am

Registration Opens and Networking Breakfast

8:45am

Day 2 Opening Remarks