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January 26-27, 2027
369W25-Convene White2 
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

Conversations3

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)

Checklist2

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.

 

Benefits2

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

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

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Mark Behn

Senior Director, Clinical Systems Quality

astrazeneca-PNG-logo

 

Rebecca Bichard
Rebecca Bichard

Director, Clinical Process Excellence and Training

Insmed Logo

 

Ashley Cafasso
Ashley Cafasso

Associate Director, Audit Management

Apellis

Priya
Priya Chaturvedi

Vice President, Head of Global Clinical Quality

Eisai

 

 

Soyoung chong-1
Soyoung Chong

Principal Quality Lead

Genentech.svg

 

Brandon Clough
Brandon Clough

Managing Director of Operations - Central Region

logo-psc-software_dark(2)

 

Grace Crawford
Grace Crawford

Formerly Global Head, Clinical Quality Management

astrazeneca-PNG-logo

 

Maureen Cunningham
Maureen Cunningham

Senior Director, Clinical Oversight, Systems and Training

United_Therapeutics_logo

 

Reetu
Reetu Dandora

Senior Vice President, Quality and Regulatory Compliance

Home - Aveo Oncology

 

 

Brian Dean
Brian Dean

Vice President, Clinical Operations

gameto-1024x460-1

 

Vinay Edwain
Vinay Edwin

Clinical Quality Leader

 

 

Kathleen Cohen
Kathleen Frenia Cohen, PharmD

Senior Vice President, Clinical Development Operations

Avalo Tx logo

 

Teresa
Teresa Gorecki

VP and Practice Director

Compliance_Architects_Logo_FINAL_RGB (8)

 

 

Sheila Gwizdak
Sheila Gwizdak

VP, Consulting

PLG Logo-HD_Landscape (2)

 

Monika Joshi
Monika Joshi

Endowed Professor in Cancer Clinical Investigation

Penn State

 

Samelyse Lees
Samelyse Lees

Inspection and Intelligence Lead, Director

GSK

 

 

Matt
Matt Lowery

CEO and Principal Consultant

PathwaysGroup_Logo-2

 

Dawn Lundin
Dawn Lundin

Vice President, Global Quality Executive Leader

 

 

Andre Morais
Andre Morais Campos

Senior Vice President, Global Clinical Operations

Press Release Service: Fierce Biotech Names ILiAD Biotechnologies to its  2024 Fierce 15 - CRISPR Medicine

Adriana Robinson-1
Adriana Robinson

Manager, Global TMF

BeOne Medicines logo vector (ai, svg) free download - Brandlogos.net

Loreena Sadowski
Loreena Sadowski

Senior Director, RDQ GCP Inspection Management

BMS logo

 

Niloy Shah
Niloy Shah

Executive Director, Research & Development Quality

Replimune

 

 

Robert Staszewski
Robert Staszewski

Associate Director, Clinical Oversight & Systems

United_Therapeutics_logo

 

Angela
Angela Teliha 

TMF Operations & Process Excellence Advisor

 

Jamie Toth
Jamie Marie Toth

Senior Director Trial Master File Management & Records

BeOne Medicines logo vector (ai, svg) free download - Brandlogos.net

 

david
David Vulcano, LCSW, MBA, CIP, RAC, FACRP

Vice President, Clinical Research Compliance & Integrity

HCA Logo

 

 

nancy
Nancy Wintering, LCSW, CCRP

Assistant Director

Thomas Jeff University

 

 

Judy
Judyth Zahora, PMP

Executive Director, Quality Assurance 

Tyra logo

 

 

Sarah Zout
Sarah Zrout

Director, Research & Development Quality

Replimune

 

10:00AM
Welcome
with Sam Smith

 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
with Sam Smith

 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
with Sam Smith

 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
with Sam Smith

 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
with Sam Smith

 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
with Sam Smith

 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
with Sam Smith

 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
with Sam Smith

 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.

Program Agenda: Day One

October 13th

 

10:00AM
Welcome
with Sam Smith

 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
with Sam Smith

 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
with Sam Smith

 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
with Sam Smith

 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
with Sam Smith

 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
with Sam Smith

 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
with Sam Smith

 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
with Sam Smith

 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.

Pricing

Pharmaceutical / Medical Device / Biotech Companies

Best Savings Available!

Super Early Bird Rate

Register by 09/11/2026

$1795

$600 Savings

Standard Rate

Register after 01/15/2027

$2395

 

Clinical Research Sites

Best Savings Available!

Super Early Bird Rate

Register by 09/11/2026

$695

$300 Savings

Standard Rate

Register after 01/15/2027

$995

 

Service Providers / Vendors

Best Savings Available!

Super Early Bird Rate

Register by 09/11/2026

$2895

$600 Savings

Standard Rate

Register after 01/15/2027

$3495

 

Click here to view the cancellation/refund/transfer policy 

Venue

 

CONVENE MEETING CENTER

convene-logo

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.

2026 Sponsors

 

PLG Logo-HD_Landscape (2) Compliance_Architects_Logo_FINAL_RGB (8) logo-psc-software_dark(2) readyroom FDAQRC Standard Logo - Full Color - M

GOLD SPONSORS

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 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

The Momentum Custom App

369W27-Grip_Web Image

 

Your all-access pass to maximize connections, meetings, and opportunities — all from the palm of your hand. Designed to elevate your event experience, the Momentum app puts you in complete control of your time, your schedule, and your success.  

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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