Join us for a Welcome Reception 6-7pm on the sixth floor foyer followed by dinner 7-9:30 pm in the Grand Ballroom at the Hilton Austin.
Tuesday, 29 April
7:30 — 8:30
CT
Networking Breakfast
8:10 — 8:30
CT
Innovation Theater - Regulatory Intelligence
8:45 — 9:30
CT
Opening Keynote
9:45 — 10:45
CT
Unifying the Clinical Platform and Simplifying Image Management with Veeva EDC
Learn how Terumo became more efficient with a unified Clinical Platform, and worked closely with Veeva product teams to develop a streamlined solution for DICOM image management. They will share how they were able to prioritized after their needs shifted, and then standardized processes within Veeva eTMF, CTMS, and EDC.
Jason Parsell
Sr. Manager, Clinical Data Management
Terumo
Jason brings 20 years of experience working in clinical data management and clinical systems in both the pharmaceutical and medical device industries. He is a quality-driven solutions manager, leveraging his experience and passion utilizing diverse strategic approaches, processes, and technologies to identify and implement business solutions.
Sessions
Unifying the Clinical Platform and Simplifying Image Management with Veeva EDC
Tuesday, 29 April
9:45 CT
Jason Parsell
Sr. Manager, Clinical Data Management
Terumo
Alcon: Achieving UDI Compliance with Veeva RIM
Hear how Alcon satisfied UDI requirements with a successful Veeva RIM implementation, including best practices for establishing a EUDAMED UDI process and additional business benefits beyond regulatory compliance.
Leane Hinds
Manager, Regulatory Intelligence, Product ID
Alcon
Leane has over 13 years of experience at Alcon, with a specific focus in product identification requirements and regulations as well as quality compliance and quality control systems. Her expertise spans project management, regulatory system implementation/technical operations, and regulation for serialization and medical device requirements. Leane regularly collaborates with internal and external teams across regulatory affairs, authorized representatives, manufacturing operations, and many industry working groups.
Sessions
Alcon: Achieving UDI Compliance with Veeva RIM
Tuesday, 29 April
9:45 CT
Leane Hinds
Manager, Regulatory Intelligence, Product ID
Alcon
BD and Smith+Nephew Driving Quality Through Integrated Risk Management
Proactive risk management is key to a quality-driven culture. Discover how leading medtechs are taking a structured, risk-based decision-making approach to enhance accountability, embed risk awareness, and align processes with quality standards.
David Wild
Global Clinical Affairs, Director of Digital Solutions
BD
David Wild is a healthcare leader with over 16 years of experience in clinical, life sciences, and digital health technology. As BD’s Director of Digital Strategy, he improves clinical trial operations through data interoperability, risk-based decision-making, and process optimization. With expertise in medical informatics, regulatory compliance, and quality systems, he focuses on embedding risk awareness into organizational culture. Currently pursuing a master’s degree in Medical Informatics at Wake Forest University, he applies academic insights to real-world challenges, advancing quality outcomes for patients and caregivers.
Sessions
BD and Smith+Nephew Driving Quality Through Integrated Risk Management
Tuesday, 29 April
9:45 CT
David Wild
Global Clinical Affairs, Director of Digital Solutions
BD
Michael Jacene
VP of Quality
Smith+Nephew
Michael brings more than 24 years of experience in the medical device industry to his role as the Head of Quality for the Orthopedics franchise at Smith+Nephew. He leads a global team responsible for the full product lifecycle from product development, through realization to post market surveillance. As a biomedical engineer with a track record of creative problem solving and leading multiple core business functions in both large and small companies, he is uniquely positioned to aid organizations in connecting strategies and processes across the business to optimize outcomes by balancing customer needs, compliance, and profitability.
Sessions
BD and Smith+Nephew Driving Quality Through Integrated Risk Management
Tuesday, 29 April
9:45 CT
Michael Jacene
VP of Quality
Smith+Nephew
Industry Panel: The Future of Commercial & Medical in Medtech
Discover how leading medtechs streamline product adoption through seamless collaboration between marketing, medical, and sales. These leaders will provide insights on industry trends, current best practices, and how to strenghten cross-functional teamwork.
Billy Stinnette
Associate Director, Material Review
Exact Sciences
With over a decade of experience in life sciences, Billy leads a team of MLR experts dedicated to communication, facilitation, innovation, and partnerships. As the system owner of Vault PromoMats and Vault MedComms, he oversees integrations, identifies efficiency opportunities, and ensures compliance in material review processes.
Sessions
Industry Panel: The Future of Commercial & Medical in Medtech
Tuesday, 29 April
9:45 CT
Billy Stinnette
Associate Director, Material Review
Exact Sciences
Veeva Best Practices: Deriving Value from Cloud Transformation
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.
10:45 — 11:30
CT
Connect Break
11:00 — 11:20
CT
Innovation Theater - Quality Risk Management
11:30 — 12:15
CT
Clinical Case Study: Modernizing Study Management
Hear how an innovative medtech company streamlined study management, reduced administrative overhead, and fostered seamless collaboration across trial teams by adopting Veeva CTMS. They'll also review how improving clinical processes enabled them to make better data-driven decisions
Alcon: Elevating Patient Focus with Veeva eCOA in a Unified Clinical Data Platform
Alcon will share how they are meeting key study milestones and prioritizing site relationships for a patient-centric approach to clinical trials with Veeva eCOA. They'll also explain how they unified operations and data to accelerate new product implementations.
Brandy Bridges
Group Head, Systems and Standards
Alcon
With over 15 years of dedicated service at Alcon, Brandy is a driving force in optimizing systems and standards to enhance efficiency and innovation. A passionate advocate for streamlined processes, Brandy focuses on simplifying complex systems to accelerate the delivery of life-changing products to patients. By aligning technology and processes with organizational goals, Brandy contributes to Alcon’s mission of improving sight and enriching lives.
Sessions
Alcon: Elevating Patient Focus with Veeva eCOA in a Unified Clinical Data Platform
Tuesday, 29 April
11:30 CT
Brandy Bridges
Group Head, Systems and Standards
Alcon
Industry Panel: Empowering Change Champions for a Global RIM Rollout
Scaling regulatory solutions to a global audience can be met with adoption challenges and cultural resistance. Hear how a leading medtech structured their RIM implementation in strategic phases, supported by change champions and a full change management program.
Larry Litle
Sr. Director Global Regulatory Affairs
Independent Consultant
Until recently, Larry led Baxter Healthcare’s global regulatory affairs operations strategy and delivery central organization, designed to align and unify regulatory systems and processes. His primary focus areas were simplifying regulatory processes, providing strategic support to business partners, and delivering global excellence across the Baxter portfolio. Prior to Baxter, Larry served in senior leadership roles within Johnson and Johnson and Sanofi-Aventis, spanning local, regional, and global functional areas, within and linked to regulatory affairs and quality.
Sessions
Industry Panel: Empowering Change Champions for a Global RIM Rollout
Tuesday, 29 April
11:30 CT
Larry Litle
Sr. Director Global Regulatory Affairs
Independent Consultant
Industry Panel: Leveraging Quality for M&A Integration Success
Medtech is seeing strong deal activity with many companies planning growth through acquisition. Hear how leading medtechs are exploring the role of quality in the deal continuum, from risk mitigation to post-transaction agility, and insights around integrating quality systems for successful mergers and acquisitions.
Fresenius: Creating Personal Marketing Experiences
Hear how an innovative medtech builds hyper-personalized marketing materials with the support of a unified platform. They'll explore innovative strategies for driving digital transformation and practical insights to help other companies get started.
Derrick Greene
Director, Marketing Content and Operations
Fresenius Medical Care
Derrick has over a decade of experience in content supply chain strategy and marketing technology. He also has expertise in creating comprehensive content lifecycle strategies to increase speed to market in an ever-changing environment. At Fresenius Medical Care, Derrick is dedicated to streamlining internal operations and driving adoption of marketing technology.
Sessions
Fresenius: Creating Personal Marketing Experiences
Tuesday, 29 April
11:30 CT
Derrick Greene
Director, Marketing Content and Operations
Fresenius Medical Care
Industry Panel: Mapping the Medical Affairs Landscape
Join chief medical officers from Sequel and other leading medtech companies for a discussion on how medical affairs teams can drive additional value, tackle new challenges, and shape the future of medtech. Explore key trends, unmet needs, and the strategic impact of medical affairs on the industry.
Joanna Mitri, MD, MS
Chief Medical Officer
Sequel Med Tech
Sessions
Industry Panel: Mapping the Medical Affairs Landscape
Tuesday, 29 April
11:30 CT
Joanna Mitri, MD, MS
Chief Medical Officer
Sequel Med Tech
12:30 — 1:15
CT
Industry Panel: Ensuring Audit-readiness with a Joint Clinical Implementation
Transitioning from point solutions to a unified clinical operations platform requires a long-term strategy and effective business case. Hear the unique approaches of three medtech companies that implemented Veeva eTMF and CTMS to automate processes and ensure audit-readiness.
Clinical Case Study: Driving Excellence in Diagnostics
In vitro diagnostics leaders will share how they are evolving to keep pace with increasingly large and complex clinical studies.
Industry Panel: Putting Regulatory Intelligence into Practice
Industry leaders and innovative medtechs will discuss how regulatory intelligence programs can streamline key information. Discover use cases for optimizing these programs and tips to drive greater business value.
Industry Panel: Modernizing Recall Management for Safer Patient Outcomes
Cardinal Health will share how recall modernization is reshaping field action responses to patient safety concerns. Learn how technology, improved communication, and patient-centered strategies are enhancing recall management to create safer environments.
Janna Parks
VP, Quality Compliance & Governance
Cardinal Health
Janna is a quality professional with over 25 years of industry experience in quality assurance, regulatory compliance, strategic planning, and departmental operations across a variety of manufacturing organizations and industries. Her diverse background in both quality operations and manufacturing leadership has been instrumental in developing successful quality system management programs, compliance programs, proactive customer focused measurement tools, cost reduction initiatives, and enhancing product and process quality. Janna currently lives in Minnesota with her family and their many pets.
Sessions
Industry Panel: Modernizing Recall Management for Safer Patient Outcomes
Tuesday, 29 April
12:30 CT
Janna Parks
VP, Quality Compliance & Governance
Cardinal Health
Baxter: Considerations for AI in Marketing Execution
A leading medtech will share their approach to AI in marketing including implications for technology, people, and processes. They'll also review tangible use cases for the exciting advancements that we've seen in recent years.
Jay Krishna
Global IT Director, Business Functions and AI
Baxter International
Jay is a technology leader in the life science industry with experience driving enterprise digital transformation programs. He is responsible for a technology team that manages medical, regulatory, and AI products at Baxter, and he's passionate about bridging the gap between AI potential and real work impact. Jay focuses on strategies that enhance operational efficiency, improve decision-making, and unlock new opportunities while ensuring safe and responsible use of AI.
Sessions
Baxter: Considerations for AI in Marketing Execution
Tuesday, 29 April
12:30 CT
Jay Krishna
Global IT Director, Business Functions and AI
Baxter International
Medical Case Study: Executing an Enterprise-wide KOL Strategy
Learn how a high growth medtech organization built a unique KOL strategy and go-to-market plan leveraging Veeva Link Key People. They'll share how they overcame enterprise-wide challenges and are now leveraging new data across the entire organization.
1:15 — 2:30
CT
Networking Lunch
2:10 — 2:30
CT
Innovation Theater - Image Management
2:45 — 3:30
CT
Accelerate Study Timelines with Connected Operations and Data - End-to-End Demo
Learn how a unified clinical ecosystem seamlessly connects patients, sites, and sponsors. This end-to-end demo showcases how to simplify and standardize across clinical operations, EDC, CDB, eCOA and Image management.
BD: Maximizing the Potential of Claims
Learn how a leading medtech is improving regulated marketing content review and approval by leveraging AI connections and partnerships. You'll also hear how they are driving claims adoption throughout the organization and using GenAI engines to accelerate personalized and compliant content production.
Veeva Quality Cloud Product Roadmap
Hear about the most recent and upcoming Veeva Quality Cloud features across QualityDocs, QMS, and Training, as well as a detailed roadmap for optimizing the overall Veeva Quality experience.
Medical Case Study: Optimizing Medical Communication and Inquiries
A leading medtech will share how they leverage medical communications and inquiries, which can often go overlooked in medtech, to drive organizational success. They'll also explore how they manage these hidden assets to enhance collaboration with patients and doctors alike.
Vault Platform Architecture
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.
3:45 — 4:30
CT
Veeva Clinical Operations Product Roadmap
Learn about recent releases, upcoming planned features, and new functionality across eTMF, CTMS, Payments, Site Connect, and Study Training including risk-based sampling, site responsibility tracking, and training matrix review.
LifeNet: Accelerating Clinical Programs with Veeva EDC
Establishing high data integrity and transparency is critical to increasing speed to market. Learn how LifeNet Health leveraged Veeva EDC to speed study development and streamline data collection to gain product approvals faster and more efficiently.
Kimberly Dorsch
Vice President, Global Clinical Affairs
LifeNet Health
Kim worked as an embryologist for almost a decade before moving from the laboratory into the clinic, first as a clinical research coordinator and then as a director of clinical research for Sentara Medical Group. In 2012, Kim joined LifeNet Health to initiate their first randomized, controlled trials and now works with the clinical affairs team, supporting all clinical trial activity for the orthopedic, spine, sports medicine, wound management, dental, and cardiovascular portfolios.
Sessions
LifeNet: Accelerating Clinical Programs with Veeva EDC
Tuesday, 29 April
3:45 CT
Kimberly Dorsch
Vice President, Global Clinical Affairs
LifeNet Health
Veeva RIM Product Roadmap
Hear about the most recent and upcoming Veeva RIM features across Registrations, Submissions, Publishing, and Archive, as well as a detailed roadmap for optimizing the overall Veeva RIM experience.
Alcon and GRAIL: Unlocking Ongoing Innovation through Strategic Partnership
Discover how Alcon and GRAIL are driving success with a holistic approach to the adoption of the Veeva Quality Cloud. Learn how partnership, communication, and prioritization contributes to ongoing success.
Ryan Nugent
Associate Director, Digital QARA Systems
Alcon
Ryan has 15+ years of experience at Alcon where he's worked in various roles across manufacturing and corporate quality. Ryan is the business system owner for Veeva Quality Cloud and Vault RIM, which includes collaborating with the Alcon business, IT, and Veeva teams to ensure continuous improvement and compliance.
Sessions
Alcon and GRAIL: Unlocking Ongoing Innovation through Strategic Partnership
Tuesday, 29 April
3:45 CT
Ryan Nugent
Associate Director, Digital QARA Systems
Alcon
Robin Farmer, Ed.D
Sr. Director Compliance Operations Records and Education
GRAIL
With 19 years of document management and training experience, Robin leads efforts in the quality/compliance arena at GRAIL, Inc., ensuring adherence to GDP standards. Robin values fostering relationships with external stakeholders to cultivate a robust record-keeping culture, which she sees as essential to effective records management for organizations.
Sessions
Alcon and GRAIL: Unlocking Ongoing Innovation through Strategic Partnership
Tuesday, 29 April
3:45 CT
Robin Farmer, Ed.D
Sr. Director Compliance Operations Records and Education
GRAIL
Veeva PromoMats Product Roadmap
See the latest Veeva PromoMats content innovations to simplify the user experience, increase speed, and enable reuse with modular content.
Veeva Medical Product Roadmap
See the latest features and capabilities of Veeva Medical, including MedComms, MedInquiry, and Link Key People.
4:30 — 5:30
CT
Connect Break
4:40 — 5:00
CT
Innovation Theater - MLR Bot
5:10 — 5:30
CT
Innovation Theater - Link
6:30 — 10:30
CT
Evening Event
Wednesday, 30 April
8:00 — 9:00
CT
Networking Breakfast
8:30 — 8:50
CT
Innovation Theater - Quality Audit Room
9:00 — 9:45
CT
Clinical Case Study: Building the Business Case for Change Management
Discover how a leading medtech unified clinical operations with the implementation of Veeva eTMF. They'll also share how they worked with Veeva Business Consulting to establish a long-term change management strategy to standardize global clinical processes.
Veeva Clinical Data Product Roadmap
Hear about the latest releases, upcoming features, and new functionality across EDC, CDB, and eCOA, including data loader and imaging.
Industry Panel: Evaluating AI in Regulatory and Quality Affairs
There is increasing interest in AI use cases for medtech regulatory and quality affairs, but can AI really replace humans on core tasks? This panel will explore how medtechs are thinking about AI tools, governance, and potential benefits as part of broader digital transformation initiatives.
Veeva Best Practices: Content Metrics Blueprint
In this session, Veeva experts will explore the groundwork for better content performance and marketing ROI. They'll also review foundational concepts on metrics, measurement, and content optimization to improve utilization and user engagement.
Veeva Best Practices: Measuring the Impact of Medical Affairs
Veeva experts will share a comprehensive framework for measuring the impact of medtech medical affairs teams including key building blocks for assessing performance, demonstrating value, and guiding strategic decision-making.
10:00 — 10:45
CT
Industry Panel: Fostering Diversity in Clinical Trials
Diverse clinical trials are essential for developing safe and effective treatments for all populations. Learn how two leading medtechs are using the Veeva Clinical Platform to enable diversity in clinical trials.
Ali Massoud
VP, Clinical Affairs
Exact Sciences
Alexandra Massoud oversees the development, execution, and quality of clinical studies to support product development and post-market evidence generation at Exact Sciences. She has extensive experience in clinical operations, sponsor partnerships, risk-based monitoring in clinical trials, and site management. Alexandra is a member of the Healthcare Businesswomen’s Association, is actively involved with MDIC, and sits on the board of directors for Triage Cancer. She is passionate about patient advocacy and health equity.
Sessions
Industry Panel: Fostering Diversity in Clinical Trials
Wednesday, 30 April
10:00 CT
Ali Massoud
VP, Clinical Affairs
Exact Sciences
Maria Restrepo, Ph.D.
Program Director, Diversity in Clinical Trials
Medtronic
Maria Restrepo, Ph.D. leads the Medtronic's efforts to ensure diverse patient representation in clinical trials. Maria has over 10 years of experience in the MedTech industry, and she joined Medtronic in 2016 as a leader in the Corporate Clinical Operations team, where she oversaw the strategy and governance of the global organization. Maria has a strong passion for health equity and is committed to removing barriers to achieve this.
Sessions
Industry Panel: Fostering Diversity in Clinical Trials
Wednesday, 30 April
10:00 CT
Maria Restrepo, Ph.D.
Program Director, Diversity in Clinical Trials
Medtronic
Paul Swift
Head of RA/CA, Americas
Carl Zeiss Meditec
Paul is currently the Head of Regulatory and Clinical Affairs, Americas, at Carl Zeiss Meditec. He is responsible for leading the RA/CA teams in the region to ensure access for the company’s innovative product portfolio across several segments. He has held prior leadership positions at Alcon and BD, holds an MS in biotechnology and is regulatory affairs certified (RAC).
Sessions
Industry Panel: Fostering Diversity in Clinical Trials
Wednesday, 30 April
10:00 CT
Paul Swift
Head of RA/CA, Americas
Carl Zeiss Meditec
Regulatory Case Study: Sequencing Regulatory Data Migration
With regulatory information distributed across multiple siloed systems, this leading medtech took a phased approach for migrating data into Veeva Registrations. Learn how they built upon early wins, reports, and measurements to set up for future success.
Industry Panel: Enabling a Culture of Quality
Creating a culture of quality requires aligning leadership vision with employee engagement. Learn how leading medtechs are fostering collaboration, accountability, and innovation to drive excellence and inspire teams across the enterprise.
Peter Shearstone
Vice President, Global Quality & Regulatory Affairs
Thermo Fisher Scientific
Peter leads a team of over 8,000 quality and regulatory affairs (Q&RA) professionals at the enterprise level and in Thermo Fisher Scientific’s many businesses and
operations spanning more than 140 countries. Under Peter's leadership, the Q&RA organization introduced the company’s first enterprise-wide quality policy, launched a company-wide initiative challenging every employee to make quality personal, built a talented global team, supported the approval and launch of hundreds of new products, and improved performance across key Q&RA metrics. Prior to joining Thermo Fisher, Peter held executive quality and regulatory roles with companies in the health care and life sciences industries during the course of nearly 35 years.
Sessions
Industry Panel: Enabling a Culture of Quality
Wednesday, 30 April
10:00 CT
Peter Shearstone
Vice President, Global Quality & Regulatory Affairs
Thermo Fisher Scientific
Industry Panel: Aligning Teams for Global Product Launch Success
Expanding products into global markets requires a strategic, collaborative approach that enables cross-functional teams to navigate complex market challenges. Hear from industry leaders on strategies, lessons learned, and innovative approaches to delivering successful product launches in dynamic global markets.
Industry Panel: Ensuring Medical Safety
Two leading medtechs will discuss the role of safety within medical affairs, including tips for modernizing medical processes and operations to align with the latest requirements.
Getting the Most Out of Reports & Dashboards
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.
10:45 — 11:30
CT
Connect Break
11:00 — 11:20
CT
Innovation Theater - Study Startup Feasibility
11:30 — 12:15
CT
Closing Keynote
12:15 — 1:30
CT
Networking Lunch
1:00 — 1:20
CT
Innovation Theater - Scientific Communication Platform