May 30 - June 1, 2023

Agenda

Tuesday, May 30
6:00p.m. — 8:00p.m. CT
Join us to network at the Welcome Reception onsite at the Hyatt Regency

Wednesday, May 31
8:00a.m. — 9:00a.m. CT
Breakfast

9:00a.m. — 9:45a.m. CT
Hear the latest innovations and new product announcements, including how to streamline the total product lifecycle.

10:00a.m. — 10:45a.m. CT
Connect document and data ecosystems between sites and sponsors to ensure multi-stakeholder collaboration, compliance, and a foundation for decentralized trials.
Shannon Amore
Sr. Systems Enablement Manager
Medtronic
Regulatory leaders will share lessons learned from their regulatory transformation journeys, including how to prepare, select, and implement RIM systems. You'll also hear key findings from our regulatory benchmark survey.
Hasan Sohail
Director - Regulatory Operations
Baxter
Kelly Barbeau
Regulatory Affairs Manager
Exact Sciences
Jaya Vaishnav
IT Project Manager
Exact Sciences
The FDA will share updates on the proposed Quality Management System Regulation and implementation, including conversion to ISO 13485, followed by perspectives from GRAIL on leveraging technology and best practices for adapting to these changes.
Capt. Kimberly Lewandowski-Walker
Regulatory Officer
FDA
Mitch Lewandowski
VP, Quality
GRAIL LLC
Marketing, IT, and Regulatory leaders from Intuitive will share how their cross-functional collaboration has effected change in their content review and approval processes, including change management, defining roles, and maximizing the use of PromoMats.
Lesly Marban
SVP Marketing
Intuitive
Madhavi Bellamkonda
Director, Regulatory Intelligence and Advertising & Promotion
Intuitive
Cardinal Health will share how business and technology work hand in hand to prepare for a successful technology implementation of Veeva Vault including defining a harmonized process, scope, and objectives to ensure successful partnership and launch, as well as challenges and lessons learned.
Abbas Syed
Manager, Software Engineering
Cardinal Health
Valerie Kessler
Manager, Global Quality Management System, Medical
Cardinal Health

10:45a.m. — 11:20a.m. CT
Connect Break

11:30a.m. — 12:15p.m. CT
Cook Research and Smith and Nephew share perspectives on the current state of the industry, challenges, and approaches; as well as discussion on the findings of the MedTech Clinical Benchmark Report.
Matt Christensen
SVP Global Clinical & Medical Affairs
Smith+Nephew
Jennifer Kerr
President
Cook Research
Elizabeth McNamara, Associate Director in the Office of Strategic Partnerships and Technology Innovation CDRH, will provide an update on the digital transformation initiatives at CDRH, including program progress since it launched in 2016 and plans for the future. Followed by audience Q&A.
Elizabeth McNamara
Assoc. Director, Acting CIO, CDRH
FDA
Industry thought leaders and experts from Epredia, GE Healthcare, and PwC will share their insights on current trends and challenges impacting the postmarket surveillance team, and what are the key considerations and success practices one must examine before embarking on the transformation journey to help maximize value and technology’s role as a true enabler.
Salil Thakar
Principal
PwC
Lisa Newcombe-Dierl
Vice President Quality
GE HealthCare
Abbott will share how they've elevated the customer experience and now support broader marketing strategies leveraging Vault PromoMats for digital asset management.
Natalya Shpolyansky
Manager, Global Branding and Channel Marketing
Abbott
M&A activity increases challenges with harmonizing data and documentation to remain compliant. Hear how a leading medtech company approached identification, data enrichment, and data migration into a single system to support modernization.
Jeanna Cameron-Pluff
Manager, Global Regulatory Affairs - Global Strategy & Delivery
Baxter

12:15p.m. — 1:15p.m. CT
Networking Lunch

1:30p.m. — 2:15p.m. CT
Alcon and Illumina share how a unified clinical data management approach reduces manual effort and ensures analysis-ready data at all times. Learn how these companies are leveraging modern approaches to help the development of clinical trial design and capture today's variety of data sources.
Philip Tayco
Associate Director, Clinical Data Management
Illumina
Leianne Ebert
Head of Clinical Data Operations
Alcon
Lessons for converting regulatory information into regulatory intelligence by interpreting, analyzing, and disseminating information across the organization and processes for success.
Quality leaders will discuss how they harmonize document management and training, streamline business processes, and standardize practices in a single system. They will also share best practices to simplify changes and ensure audit readiness.
Marla Claycomb
Sr. Manager, NM QMS
LivaNova USA
Mark Ramser
VP, Quality & Regulatory
Practices for building a solid claims foundation, including clear substantiation processes, governance teams, and global implementation, to accelerate content creation, approval, and distribution to customers.
Becki Brasher
Senior Regulatory Manager, Ad Promo
Medtronic
Rosetta Mazzei
Promotional Advertising Review Committee Leader
CooperSurgical
Alcon and Illumina share approaches to implementing and connecting multiple Veeva Vaults; including how to gain efficiency, manage connections between Vaults, and drive adoption for success.
Todd Steppick
Director, DevOps, Integrations and AMS
Alcon
Monica Das
Sr. Business Systems Analyst, Vault Enterprise Technical Owner
Illumina

2:30p.m. — 3:30p.m. CT
See the latest features across Vault Clinical Data Management applications and upcoming updates this year.
See the latest features across the Regulatory Suite and updates coming this year.
See the latest features across the Vault Quality Suite and upcoming this year.
See the latest enhancements to Vault PromoMats, MedComms, Med Inquiry and upcoming features this year.

3:30p.m. — 4:15p.m. CT
Connect Break

4:15p.m. — 5:00p.m. CT
Clinical leaders will share how they approached digital transformation across the clinical organization including where to start, best practices for technology implementation, and business process optimization to be always inspection ready.
Jason Parsell
Sr. Manager, Clinical Data Management
Terumo
Joris Van Dam
VP, Clinical Trials Innovation
Exact Sciences
Heidi Ortiz
VP, Clinical Operations
Alcon
Unique Device Identification and other regulatory initiatives demand larger and constantly changing datasets throughout the product lifecycle. Join Jay Crowley, who led the development and implementation of FDA’s UDI system, to hear trends and how to devise a data management strategy that equips your organization for the future.
Jay Crowley
VP, Medical Devices
USDM Life Sciences
Learn about Veeva Link MedTech, a data application developed for medtech companies to identify scientific experts, personalize engagement, and map activities across the healthcare ecosystem.
Terumo Microvention will share their approach to balancing process harmonization and alignment across studies to transition toward a single source of truth, including how they got teams up and running on Vault eTMF and CTMS to build actionable insights across studies, resolve collaboration and onboarding challenges, and meet milestones to jumpstart the digital transformation journey.
Robert Gash
Sr. Director, Clinical Research & Operations (US & China)
MicroVention

6:30p.m. — 11:00p.m. CT
Join us for dinner, networking, and entertainment at Navy Pier. Transportation will be provided from the Hyatt Regency.

Thursday, June 1
8:00a.m. — 9:00a.m. CT
Breakfast

9:00a.m. — 9:45a.m. CT
See the new features across Vault Clinical Operations, including eTMF, CTMS, and Payments, and how to leverage these capabilities to improve clinical operations and trial performance.
Former FDA Associate Director Kim Trautmann will share perspectives on the latest risk management trends and the impact to day-to-day operations in regulatory affairs. She'll also share how technology can help address the challenges facing medtech now and in the future.
Kimberly A Trautman
Managing Director and VP
MEDIcept
Quality experts from Cardinal Health, LivaNova, and PwC will share business cases for change, how to leverage technology to drive enterprise transformation, and tactics to manage the stages of change management.
Barbara Law
Director, Project Management, eQMS
Cardinal Health
Ravi Hariharan
Director, IT Business Partner
LivaNova
Kareem Elwakil
Partner
PwC
Agilent's medical science liaisons will share how they leverage Veeva Link MedTech to identify, segment, and prioritize experts for impactful omnichannel engagement.
Pardeep Kaurah
Medical Science Liaison
Agilent Technologies, Inc
Alcon will share best practices for building partnerships between IT and the business to support enterprise application implementation and global adoption across commercial, quality, and R&D. Starting with the right executive sponsorship, they were able to build focused guiding principles and supporting operating structure that enabled successful expansion of Vault.
Greg White
IT Director Regulatory, Medical & Veeva Quality
Alcon
Justin Janda
Director, R&D IT, Clinical Systems
Alcon

10:00a.m. — 10:45a.m. CT
BD and Integra LifeSciences will share their clinical transformation stories, including how implementing a unified clinical suite enables process consistency, more efficient trial management, inspection readiness, and speed to market.
David Sheleheda
Head of Clinical Operations
Integra LifeSciences
Sarah Giorgio
Manager, Clinical Systems Architecture, Operations, & Strategy
BD
Learn how regulatory teams are measuring performance of RIM systems with key indicators and hear best practices for ongoing user adoption.
Ann Zarubaiko Sturgill
Regulatory Operations, Global Director
Cook Medical
The Case for Quality program is intended to help the FDA identify device manufacturers that consistently produce high-quality devices. Hear from FDA and industry experts on how technology can enable adoption of best practices defined within the Case for Quality program.
Cisco Vicenty
Program Manager, Case for Quality
FDA
Steve C de Baca
Chief Patient Safety and Quality Officer
Philips
CMO perspectives on how to partner with KOLs to improve patient outcomes and access to quality care through strategic initiatives.
Dr. Nick West
Chief Medical Officer & Divisional Vice-President, Global Medical Affairs
Abbott Vascular

10:45a.m. — 11:20a.m. CT
Connect Break

11:20a.m. — 12:00p.m. CT
What does the future hold as health systems undergo changes due to the rise of digital health and home based care? How should medtech adapt its operating model for HCP engagement due to the changing role of physicians? How can medtech manufacturers respond to growing cost pressures and remain successful? Join Dr. Nick West for a fireside chat to explore these and other topics from the perspective of a CMO.
Dr. Nick West
Chief Medical Officer & Divisional Vice-President, Global Medical Affairs
Abbott Vascular

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

1:00p.m. — 2:30p.m. CT
Join fellow Vault Clinical Operations users for a roundtable discussion on the following topics: Strategies and best practices for optimizing clinical trials and day-to-day operations using Vault, Expansion of the clinical suite - adopting new Veeva Clinical applications, features and functionality, and release management – a new approach to release updates, assessing and enabling new features.
Join fellow Vault RIM users for a roundtable discussion on the following topics: Submission Content Plans - Content Plan best practices - New eSTAR content plan template Release Management - New release communications model - Reasons to stay up-to-date with releases and enabling features Events, Impact Assessments - Using events to better manage business processes such as Regulatory Impact Assessments and major changes
Join fellow Vault Quality Suite users for a roundtable discussion on the following topics: Supplier Quality and External Collaboration QualityDocs and Process Navigator/Quality Relationships Panel Release Management - New release communications model - Reasons to stay up-to-date with releases and enabling features
Join fellow Vault PromoMats users and Veeva product and services experts for a roundtable discussion on the following topics: Claims, Release Management, and Brand Portal.
Join this interactive session to learn about our plans to support imaging data in EDC, view a demo of MVP prototypes and hear about our vision for the future

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