April 29 - May 1, 2024

Agenda

Monday, April 29
6:00p.m. — 9:30p.m. CT
Welcome Reception & Dinner

Tuesday, April 30
7:30a.m. — 8:30a.m. CT
Networking Breakfast

8:45a.m. — 9:30a.m. CT
Hear the latest innovations and new product announcements, including how to streamline the total product lifecycle.

9:45a.m. — 10:30a.m. CT
Effective clinical trial execution relies on clean, timely data from various sources. Learn how BD is leveraging Vault CDMS and Payments to streamline data management, improve workflows, and reduce the burden on sites and internal teams.
Christy Zeigler
Director, Clinical Data Management
BD
Kelley Crist
Director, Clinical Data Management
BD
Vanessa Fulginiti
Sr. Clinical Systems Architecture Specialist
BD
An innovative medtech will share their adoption journey from data migration to process implementation to roll-out. They'll also review best practices for deploying a new RIM solution to a global team spanning different challenges and needs.
The role of the quality organization continues to develop as modern healthcare is transformed by a blend of technological innovations. Hear from quality executives on how key aspects of quality, including processes, systems, talent, and culture, are evolving with changing customer expectations and the need for operational agility.
Steve C de Baca
Chief Patient Safety and Quality Officer
Philips
Nidia Acevedo
Sr. Vice President, Global Quality Compliance
Eli Lilly and Company
Learn about Philips' journey to transform marketing claims management, including the case for change, required foundations for success, and overcoming roadblocks.
Christina Villar
Head Clinical Affairs
Philips
Valeria Bogomolnaya
Marketing Claims Specialist
Philips
Keeping your Vault up to date is critical for maximizing value and maintaining team engagement. Hear how Alcon handles release management, validates new functionality, and optimizes performance throughout the year.
Todd Steppick
Director, DevOps, Integrations and AMS
Alcon
Justin Janda
Director, R&D IT, Clinical Systems
Alcon
Learn how Avita Medical rolled out Link Key People for MedTech across all medical, marketing, and sales teams to reach experts in new specialities and support expanded indications.
Brad Wiggins
Director of Professional Relations
AVITA Medical

10:30a.m. — 11:00a.m. CT
Connect Break

11:00a.m. — 11:45a.m. CT
Harmonization of processes and technologies are at the foundation of building a collaborative ecosystem for clinical trials. Learn how leading medtech companies are achieving efficiency, compliance, and value from modernization efforts, both internally with study teams and externally via collaboration with research sites.
Shannon Amore
Sr. Systems Enablement Manager
Medtronic
Matt Christensen
SVP Global Clinical & Medical Affairs
Smith+Nephew
Don't miss out on the latest updates in the MedTech regulatory landscape. Industry experts from Veeva and medtech organizations will share key insights on the complex regulatory environment including EU MDR, eSTAR, UDI, global harmonization, and real world evidence.
Hear best practices and learnings from Bio-Rad's quality transformation including alignment with business strategy and building a roadmap for the future.
Elizabeth Platt
Vice President, Regulatory & Clinical Affairs
Bio-Rad Laboratories
Kerry Lovejoy
Director, QA/RA/CA PMO & Quality Integrations
Bio-Rad Laboratories
Learn how BD transformed their process for managing medical content and inquiries into a modern, digital approach. Understand what led to the decision, how the team rallied behind a common objective, and hear tips to operationalize in your organization.
Cassie Singleton
Director, Medical Information
BD
Hear how leading medtech companies are unlocking value through operational tactics like business case definition and ongoing value realization projects. We'll also review how to prioritize strategic business objectives within your technology transformation roadmap.

12:00p.m. — 12:45p.m. CT
The Medical Device Innovation Consortium along with CDISC and the FDA have recently invested in a project focused on data standardization for IVD devices. This session will provide an update on what has been accomplished, learnings, and how it can be applied to divide portfolios to driver better interoperability with the push to leverage real-world data and the continued rise of AI/ML.
Jon Neville
Senior Director, Clinical Data Standards
CDISC
Pipper White
Senior Program Manager
MDIC
Learn how USDM is tackling UDI compliance with a holistic data management approach. They’ll explore how to drive success beyond regulatory requirements with practical insights and strategies for effective implementation.
Jay Crowley
VP, Medical Devices
USDM Life Sciences
Hear a case study from a Teleflex on how to successfully launch a quality transformation program including considerations for how to organize and bring together multiple remote sites, ways of working, and business process alignment.
Meagan Zack
Program Manager
Teleflex Inc.
See how J&J Vision streamlines marketing content with a global-to-Local approach. Dive into their journey of creating a unified process for assets and claims. Discover winning localization tactics, effective change management techniques.
Stephanie Carter
Promotional Integrity Manager
Johnson & Johnson MedTech - Vision
Join this session to hear how Glaukos aligned their business and technology needs to meet growing organizational requirements. They'll share how they developed a center of excellence and focused on nimble and effective solutions to reach their digital transformation objectives.
David Hohler
Sr. Director, Global Technology Solutions
Glaukos
Learn how GE Healthcare is leveraging technology and accessing real-time KOL intelligence to drive medical excellence and enable high-impact HCP engagements.
Dr. Dustin M. Dunham
Head of Medical Affairs, Americas
GE HealthCare | Pharmaceutical Diagnostics
Christine Brand
Medical Director - Oncology, Care Area Lead
GE HealthCare

12:45p.m. — 1:45p.m. CT
Networking Lunch

1:45p.m. — 2:30p.m. CT
Medtech CROs are focused on conducting and executing clinical trials in the medical device and diagnostic space. With continual regulatory and clinical changes, what strategies are being used to drive innovation and time to value for all involved (patients, sites, sponsors, CROs).
Jodi Mullin
Manager, Clinical Operations
NAMSA
Robin Solinsky
Director of Clinical Data Systems
Bright Research
Emily Friedland
VP of Clinical Research
DCN Dx
Alcon will share cutting-edge strategies and processes for leveraging the Vault RIM Platform. Learn how they have achieved excellence and standout contributions for shaping the future of efficient data management across the organization.
Greg White
IT Director Regulatory, Medical & Veeva Quality
Alcon
See the latest Vault Quality innovations to bring speed and simplicity to critical quality processes, including complaint handling, audits, learning management, and more.
See the latest Vault PromoMats content innovations to simplify the user experience, increase speed, and enable reuse with modular content.
Improve your organization's visibility into operational processes, application usage, and KPIs with Vault reports and dashboards. Learn about Vault reporting's core tools and how to use them to convert an idea for a metric into an actionable dashboard.
Learn how Edwards is leveraging the Link platform to improve the customer experience including streamlining KOL selection, increasing impact, and ensuring compliant engagement strategies.
Carlos Paret
Medical Affairs Director - Operations
Edwards Lifesciences

2:45p.m. — 3:30p.m. CT
The Link Key People for MedTech product team will cover recent and upcoming features for 2024, including Educational Background, Company Collaboration, Clinical Tab, and Trends.
Hear about the recent releases and new features planned for the upcoming year for EDC and CDB, including data loader and imaging.
Vault RIM Product Roadmap
The Case for Quality program and Computer Software Assurance (CSA) are intended to implement risk-based approaches to support device manufacturers to consistently produce high-quality devices. Hear from FDA and Veeva experts on how technology can enable adoption of best practices defined within the Case for Quality program and implementation of CSA methodology.
Daniel Walter
Policy Analyst
FDA
Learn how Abbott prepared for and handled its first Periodic Review to keep marketing content current and compliant. You will hear lessons learned on how to administer, what to anticipate, and dos and don'ts followed by a group discussion.
Natalya Shpolyansky
Manager, Global Branding and Channel Marketing
Abbott

3:30p.m. — 4:00p.m. CT
Connect Break

4:15p.m. — 5:00p.m. CT
Join us for a compelling discussion on achieving health equity. Boston Scientific, Medtronic, and patient advocates will share their insights on key strategies to bridge the healthcare gap by leveraging data, building provider collaboration, and empowering patients.
Paige Bingham
Director, Close the Gap
Boston Scientific
Austin L Chiang, MD MPH
Chief Medical Officer, Medtronic Endoscopy
Medtronic

6:30p.m. — 11:00p.m. CT
Evening Event - Stubb's BBQ

Wednesday, May 1
8:00a.m. — 9:00a.m. CT
Networking Breakfast

9:00a.m. — 9:45a.m. CT
The Vault Clinical Operations team will cover recent releases and new features planned for the upcoming year for the clinical operations platform. Learn about new features across eTMF, CTMS, Payments, and Site Connect.
US FDA will share valuable insights on current harmonization efforts including the Quality Management System Regulation (QMSR) final rule and International Medical Device Regulators Forum (IMDRF) activities. We’ll finish with a panel discussion including Thermo Fisher and another leading medtech on best practices to streamline regulatory and quality processes and ensure compliance in today's evolving regulatory landscape.
Davina Marano
Sr. International Counsel, Office of the Center Director, CDRH
US Food and Drug Administration
Peter Shearstone
Vice President, Global Quality & Regulatory Affairs
Thermo Fisher Scientific
Elizabeth Platt
Vice President, Regulatory & Clinical Affairs
Bio-Rad Laboratories
See the latest Vault Medical enhancements to improve medical communications, promote content reuse, and streamline Medical Inquiry intake and fulfillment.
Join this session to hear how Philips worked cross-functionally to improve the way they manage assets, claims, and events across the product development lifecycle. They'll also provide an overview of their digital transformation journey, including the challenge of getting your data right.
Christina Villar
Head Clinical Affairs
Philips
Hear the latest and upcoming features for both Vault MedComms and Vault MedInquiry

10:00a.m. — 10:45a.m. CT
Learn how a leading global medtech company's technology transformation from legacy systems to Vault Clinical enabled them to centralize data and streamline processes to drive efficiency.
Disha Mittal
Associate Director, Clinical Technology Strategy
Boston Scientific
Niharika Brahmbhatt
Sr. Director, Global Clinical Technology Strategy & Enablement
Boston Scientific
Join Sajjad Syed from the Division of Regulatory Programs at FDA to hear insights into future pathways for electronic templates. He’ll explain the evolution of eSTAR and how it may shape regulatory submission practices.
Sajjad Syed
Software Engineer
FDA
A mature, industry-specific LMS is essential for medtech organizations to ensure compliance, job readiness, and safety while reducing manual work and gaining greater visibility through automation. Learn from panelists as they share perspectives on implementing Vault Training, benefits received to date, and future enhancement plans.
Yvonne Yeo
Quality Manager
Corza Medical (Pearsalls)
Jonathan Fessler
Manager, Global Quality Training
Glaukos
Learn how Zimmer Biomet accelerated compliant digital content creation leveraging a unified DAM, including how connecting DAM to review and approval has allowed their in-house creative teams to create content faster, ensure compliance, and achieve their broader goal of getting the right message to the right person at the right time.
Amy Jo Brown
Marketing Operations Specialist
Zimmer Biomet
Learn how the Vault Platform is evolving to support medtech customers across all domains. We'll review recent highlights around user productivity and scalability along with cross-functional connections to maximize value.

10:45a.m. — 11:15a.m. CT
Connect Break

11:20a.m. — 12:00p.m. CT
Three CMOs from leading medtechs weigh in on how medical technology, digitalization, and hyper-personalization are impacting patient care and overall healthcare delivery.

12:00p.m. — 1:00p.m. CT
Networking Lunch

1:00p.m. — 3:00p.m. CT
Join this interactive session with CDMS Product to see the upcoming Image Management module, and learn more about the latest features and functionality in Vault CDMS. Connect and collaborate with your peers and Veeva experts during an open discussion around best practices and relevant clinical data topics.
Collaborate with your peers and Veeva experts during an open discussion on clinical operations best practices and how to leverage Vault Clinical applications to drive efficiency. You'll have the opportunity to share approaches and learn how your peers are leveraging Vault. We'll also dive into the latest features.
Collaborate with your peers and Veeva experts during an open discussion on regulatory best practices and how to leverage Vault RIM applications to drive efficiency and compliance. You'll have the opportunity to share approaches and learn how your peers are leveraging Vault. We'll also dive into the latest features.
Collaborate with your peers and Veeva experts during an open discussion on quality best practices and how to leverage Vault applications to drive efficiency and safety. You'll have the opportunity to share approaches and learn how your peers are leveraging Vault. We'll also dive into the latest features of Vault Quality Platform.
Collaborate with your peers and Veeva experts during an open discussion on commercial and claims management best practices and how to leverage Vault applications to drive efficiency, compliance, and speed to market. You'll have the opportunity to share approaches and learn how your peers are leveraging Vault. We'll also dive into the latest features.

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