January 26-27, 2027
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
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:
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Clinical sponsor professionals, including:
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Inspection Readiness
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Trial Master File (TMF) Management
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Clinical Quality
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Clinical Operations
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Document Management
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Quality Assurance / Quality Management
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Clinical Oversight
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Clinical Systems & Technology
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Regulatory Affairs (GCP-focused)
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Compliance & Audit Management
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Risk-Based Quality Management (RBQM)
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Clinical Research Sites
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Trial Master File Providers
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Clinical Quality / GCP Service Providers
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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:
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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.
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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.
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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.
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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:
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Hear from 20+ inspection readiness leaders sharing proven strategies and lessons learned
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Gain insights from 5+ clinical sites on real-world inspection readiness implementation
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Learn from 4+ in-depth case studies highlighting successful sponsor and site approaches
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Participate in 7+ hours of dedicated networking with peers and industry experts
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Engage with leading consultants, technology providers, and service partners driving readiness innovation
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Walk away with tangible strategies and best practices to strengthen your inspection readiness program
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Join interactive panel discussions and engaging breakout sessions for practical, actionable learning
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Discover ICH E6(R3)-aligned frameworks to improve compliance across your trials
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Build lasting relationships that support your readiness journey year-round
Speaking Faculty
Are you driving excellence in inspection readiness?
We’re looking for forward-thinking leaders in pharma, biotech, and medical devices to speak at the 2nd Annual Inspection Readiness 360 Summit—a unique forum dedicated to aligning quality, regulatory, and operational teams for successful inspections
Do you have a story to share?
2026 Featured Speakers
Mark Behn
Senior Director, Clinical Systems Quality
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Rebecca Bichard
Director, Clinical Process Excellence and Training
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Ashley Cafasso
Associate Director, Audit Management
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Priya Chaturvedi
Vice President, Head of Global Clinical Quality

Soyoung Chong
Principal Quality Lead
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Brandon Clough
Managing Director of Operations - Central Region
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Grace Crawford
Formerly Global Head, Clinical Quality Management
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Maureen Cunningham
Senior Director, Clinical Oversight, Systems and Training
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Reetu Dandora
Senior Vice President, Quality and Regulatory Compliance

Brian Dean
Vice President, Clinical Operations

Vinay Edwin
Clinical Quality Leader
Kathleen Frenia Cohen, PharmD
Senior Vice President, Clinical Development Operations
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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
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Matt Lowery
CEO and Principal Consultant

Dawn Lundin
Vice President, Global Quality Executive Leader
Andre Morais Campos
Senior Vice President, Global Clinical Operations

Adriana Robinson
Manager, Global TMF
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Loreena Sadowski
Senior Director, RDQ GCP Inspection Management
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Niloy Shah
Executive Director, Research & Development Quality
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Robert Staszewski
Associate Director, Clinical Oversight & Systems
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Angela Teliha
TMF Operations & Process Excellence Advisor
Jamie Marie Toth
Senior Director Trial Master File Management & Records
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David Vulcano, LCSW, MBA, CIP, RAC, FACRP
Vice President, Clinical Research Compliance & Integrity
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Nancy Wintering, LCSW, CCRP
Assistant Director
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Judyth Zahora, PMP
Executive Director, Quality Assurance
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Sarah Zrout
Director, Research & Development Quality
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10:00AM
Welcome
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10:00AM
Welcome
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10:00AM
Welcome
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10:00AM
Welcome
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10:00AM
Welcome
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10:00AM
Welcome
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10:00AM
Welcome
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10:00AM
Welcome
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Program Agenda: Day One
October 13th
10:00AM
Welcome
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10:00AM
Welcome
Master cleanse kombucha tumeric brooklyn whatever selvage, portland quinoa. Austin mlkshk pour-over kickstarter beard, put a bird on it palo santo lomo single-origin coffee master cleanse fashion axe keffiyeh hexagon art party activated charcoal.
10:00AM
Welcome
Master cleanse kombucha tumeric brooklyn whatever selvage, portland quinoa. Austin mlkshk pour-over kickstarter beard, put a bird on it palo santo lomo single-origin coffee master cleanse fashion axe keffiyeh hexagon art party activated charcoal.
10:00AM
Welcome
Master cleanse kombucha tumeric brooklyn whatever selvage, portland quinoa. Austin mlkshk pour-over kickstarter beard, put a bird on it palo santo lomo single-origin coffee master cleanse fashion axe keffiyeh hexagon art party activated charcoal.
10:00AM
Welcome
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10:00AM
Welcome
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10:00AM
Welcome
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10:00AM
Welcome
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Pricing
Pharmaceutical / Medical Device / Biotech Companies
Clinical Research Sites
Click here to view the cancellation/refund/transfer policy
Venue
CONVENE MEETING CENTER
TWO COMMERCE SQUARE
2001 Market Street, Philadelphia, PA 19103
View Map ➜
Please note there is no exclusive housing block for this event. If you are contacted by a 3rd party housing company claiming to have a relationship with Momentum Events Group LLC, or its event, these companies and others like it are not in any way affiliated with us.
Interested in learning more?
Click below to schedule a meeting with our sponsorship team!
Testimonials
"Overall I feel that the summit was engaging and a wonderful opportunity to network and meet other TLLs"
"TLL provided additional, tools, strategy and network"
"This summit was informative and helpful to me in order to perform my day to day TLL functions"
"Pleasantly Surprised"
"Very applicable & Informative"
"Focused on our unique role"
The Momentum Custom App

Want direct access to every power player on site — and the freedom to connect on your own terms? You’ve got it. This is networking, redefined.
- ✨ AI-Powered Matchmaking
- 🤝 Unlimited Meetings
- 🗓️ Custom Agendas
- 📍 Seamless Navigation
Frequently Asked Questions
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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.
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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
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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 Arianne Leclair at Arianne@momentumevents.com to secure the best group discounts
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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.
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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.
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6. How Do I Network? (Spoiler: It’s Easier Than You Think)
We make networking feel natural — not awkward. From structured roundtables and topic lounges to networking receptions and interactive sessions, there are plenty of ways to meet people who matter to your work (and might just become collaborators or friends). Just bring your curiosity — we’ll handle the rest.


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