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
See how Veeva and Redica are teaming up to bring regulatory intelligence to the Veeva RIM Platform with a live demo.
8:45 — 9:30
CT
Opening Keynote
9:45 — 10:45
CT
Terumo: Unifying the Clinical Platform and Simplifying Image Management with Veeva EDC
Learn how Terumo improved operational efficiency 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 prioritize amid shifting needs and standardize 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
Terumo: 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
Thermo Fisher Scientific: Enabling a Culture of Quality
Creating a culture of quality requires aligning leadership vision with employee engagement. Learn how Thermo Fisher Scientific is 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
Thermo Fisher Scientific: Enabling a Culture of Quality
Tuesday, 29 April
9:45 CT
Peter Shearstone
Vice President, Global Quality & Regulatory Affairs
Thermo Fisher Scientific
BD, Exact Sciences, & Teleflex: Future of Commercial & Medical Affairs
Discover how BD, Exact Sciences, and Teleflex 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 strengthen cross-functional teamwork.
Enrique Carlos
Digital Delivery Director
BD
Enrique has 15+ years of experience building digital customer experiences across consumer goods, technology, electronics, and real estate. At BD, Enrique drives digital standards, capabilities, and campaigns at scale. His AI initiative streamlines content creation, enabling marketers to generate high-quality content in minutes.
Sessions
BD, Exact Sciences, & Teleflex: Future of Commercial & Medical Affairs
Tuesday, 29 April
9:45 CT
BD: Maximizing the Potential of Claims
Tuesday, 29 April
2:45 CT
Enrique Carlos
Digital Delivery Director
BD
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
BD, Exact Sciences, & Teleflex: Future of Commercial & Medical Affairs
Tuesday, 29 April
9:45 CT
Billy Stinnette
Associate Director, Material Review
Exact Sciences
Michelle Fox
Corporate Vice President and Chief Medical Officer
Teleflex Inc
Michelle Fox and her leadership team set the clinical vision and strategy for Teleflex. She helps guide both medical affairs to assure compliance with global regulatory, legislative, and medical requirements and clinical affairs to implement multidisciplinary clinical development programs covering a broad range of products and therapeutic areas. Michelle also leads the scientific, clinical research and market access, reimbursement, and health policy arm of the organization. She is particularly passionate about sustainable healthcare, health equity, diversity equity, and inclusion and holds a position on the respective global councils.
Sessions
BD, Exact Sciences, & Teleflex: Future of Commercial & Medical Affairs
Tuesday, 29 April
9:45 CT
Sequel & Teleflex CMOs Talk Mapping the Medical Affairs Landscape
Tuesday, 29 April
11:30 CT
Closing Keynote: Unifying for Safety - How Clinical, Quality, and Medical Affairs Drive Patient Protection
Wednesday, 30 April
11:30 CT
Michelle Fox
Corporate Vice President and Chief Medical Officer
Teleflex Inc
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
See how Veeva QMS enables proactive risk management across your quality operations.
11:30 — 12:15
CT
Boston Scientific: Navigating Clinical Operations in Medtech Mergers and Acquisitions
Acquiring a new business brings significant challenges for clinical operations teams, from unifying processes to ensuring compliance—all while maintaining trial continuity. Harmonizing clinical systems is critical to enable seamless data integration, operational efficiency, and cross-team collaboration.
Niharika Brahmbhatt
Sr. Director, Global Clinical Technology Strategy & Enablement
Boston Scientific
Niharika is an experienced leader in the medical devices industry, specializing in clinical operations and system implementation, including Veeva eTMF and CTMS. She serves on the global clinical operations team at BSC, where she leads the development and management of global clinical systems and applications. Her responsibilities include implementing cutting-edge technologies and establishing robust clinical infrastructure through global SOPs/WIs, clinical L&D, acquisition integration, and vendor partnership management.
Sessions
Boston Scientific: Navigating Clinical Operations in Medtech Mergers and Acquisitions
Tuesday, 29 April
11:30 CT
Niharika Brahmbhatt
Sr. Director, Global Clinical Technology Strategy & Enablement
Boston Scientific
Disha Mittal
Associate Director, Clinical Technology Strategy
Boston Scientific
Disha Mittal is an experienced IT leader driving digital transformation across clinical platforms and data ecosystems. She has proven expertise in enabling evidence-based insights and outcomes through strategic technology leadership and cross-functional collaboration. Disha's deep domain knowledge spans core clinical systems and processes, including EDC, CTMS, eTMF, safety, and reporting, and she's known for aligning technology with clinical objectives to enhance efficiency, compliance, and decision-making.
Sessions
Boston Scientific: Navigating Clinical Operations in Medtech Mergers and Acquisitions
Tuesday, 29 April
11:30 CT
Disha Mittal
Associate Director, Clinical Technology Strategy
Boston Scientific
Agilent, DCN Dx, Illumina: Driving Excellence in Diagnostics
Agilent, Illumina, and DCN Dx share how they improve efficiency in study execution to speed time to market and improve patient outcomes with crucial in vitro diagnostics.
Gregory Cherryholmes
Senior Clinical Development Scientist - Strategy
Agilent Technologies
Greg currently works as a Senior Clinical Development Scientist-Strategy for the global clinical affairs group at Agilent Technologies, where he has been for the past 9.5 years. During his tenure, he led the implementation and provides ongoing support for eTMF, CTMS, CDB, and EDC systems to support analytical validation studies and clinical trials in the development of Agilent’s companion diagnostic assays.
Sessions
Agilent, DCN Dx, Illumina: Driving Excellence in Diagnostics
Tuesday, 29 April
11:30 CT
Gregory Cherryholmes
Senior Clinical Development Scientist - Strategy
Agilent Technologies
Matthew Purner
Sr. Director, Regulatory & Clinical Affairs
Illumina, Inc.
Matt has 20+ year of leadership experience across academic research, biopharmaceutical, and IVD industries. As Sr. Director, Clinical Affairs at Illumina he is focused on the success and growth of their Next Generation Sequencing division. He has extensive experience working with the Veeva Clinical Platform, having supported the implementation of both clinical operations and clinical data management solutions at Illumina.
Sessions
Agilent, DCN Dx, Illumina: Driving Excellence in Diagnostics
Tuesday, 29 April
11:30 CT
Matthew Purner
Sr. Director, Regulatory & Clinical Affairs
Illumina, Inc.
Thomas Martinache
Associate Director of Data Management
DCN Dx
Thomas has worked in Data Management for the last 15 years. He has worked at various CROs and sponsors, mostly on Cardiology and Oncology studies. DCN, specializes in IVD studies, helping clients run studies and manage the challenges those can present. DCN works with them from protocol creation, through sites and system selection, all the way to the statistical reports and submissions.
Sessions
Agilent, DCN Dx, Illumina: Driving Excellence in Diagnostics
Tuesday, 29 April
11:30 CT
Thomas Martinache
Associate Director of Data Management
DCN Dx
Global Medtech Regulations Roundup
Don't miss the latest updates on the increasingly complex medtech regulatory landscape, including key insights on EU MDR, eSTAR, UDI, global harmonization, and real world evidence.
Erik Vollebregt
Partner
Axon Lawyers
Erik specialises in EU and national legal and regulatory issues relating to medical devices, IVDs, medicines and biotechnology, with a focus on legal and regulatory advice, contracts, regulatory litigation against competent authorities and M&A. Erik is the author of the acclaimed Medicadeviceslegal.com blog and The Enriched MDR and IVDR handbook.
Sessions
Global Medtech Regulations Roundup
Tuesday, 29 April
11:30 CT
Erik Vollebregt
Partner
Axon Lawyers
BD and Smith+Nephew: Driving Quality Through Integrated Risk Management
Proactive risk management is key to a quality-driven culture. Discover how BD and Smith+Nephew 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
11:30 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
11:30 CT
Closing Keynote: Unifying for Safety - How Clinical, Quality, and Medical Affairs Drive Patient Protection
Wednesday, 30 April
11:30 CT
Michael Jacene
VP of Quality
Smith+Nephew
Fresenius Medical Care: Creating Personal Marketing Experiences
Hear how Fresenius Medical Care 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 Medical Care: Creating Personal Marketing Experiences
Tuesday, 29 April
11:30 CT
Derrick Greene
Director, Marketing Content and Operations
Fresenius Medical Care
Sequel & Teleflex CMOs Talk Mapping the Medical Affairs Landscape
Join chief medical officers from Sequel and Teleflex 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
Sequel & Teleflex CMOs Talk Mapping the Medical Affairs Landscape
Tuesday, 29 April
11:30 CT
Joanna Mitri, MD, MS
Chief Medical Officer
Sequel Med Tech
Michelle Fox
Corporate Vice President and Chief Medical Officer
Teleflex Inc
Michelle Fox and her leadership team set the clinical vision and strategy for Teleflex. She helps guide both medical affairs to assure compliance with global regulatory, legislative, and medical requirements and clinical affairs to implement multidisciplinary clinical development programs covering a broad range of products and therapeutic areas. Michelle also leads the scientific, clinical research and market access, reimbursement, and health policy arm of the organization. She is particularly passionate about sustainable healthcare, health equity, diversity equity, and inclusion and holds a position on the respective global councils.
Sessions
BD, Exact Sciences, & Teleflex: Future of Commercial & Medical Affairs
Tuesday, 29 April
9:45 CT
Sequel & Teleflex CMOs Talk Mapping the Medical Affairs Landscape
Tuesday, 29 April
11:30 CT
Closing Keynote: Unifying for Safety - How Clinical, Quality, and Medical Affairs Drive Patient Protection
Wednesday, 30 April
11:30 CT
Michelle Fox
Corporate Vice President and Chief Medical Officer
Teleflex Inc
12:30 — 1:15
CT
Veranex: Driving Clinical Innovation with a Digital-centric Approach
Reduced budgets, resource constraints, and accelerated timelines are challenging innovation in the medtech industry. Learn how Veranex is modernizing systems and taking a digital-centric approach to maintain efficiency and drive innovation.
Lisa Boyle
Chief Innovation Officer
Veranex
Lisa Boyle serves as chief innovation officer, leveraging over 15 years of medical technology and clinical experience. Prior to her current role, she held senior leadership positions including senior director of clinical operations at Medtronic, vice president of global clinical affairs and medical affairs strategy at BD, and vice president of clinical and medical affairs at JenaValve. Lisa brings comprehensive expertise across business unit, corporate, and small business operations, with particular focus on real-world evidence, data analytics, and operational excellence.
Sessions
Veranex: Driving Clinical Innovation with a Digital-centric Approach
Tuesday, 29 April
12:30 CT
Lisa Boyle
Chief Innovation Officer
Veranex
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
12:30 CT
Brandy Bridges
Group Head, Systems and Standards
Alcon
Medtronic and Smith+Nephew: Putting Regulatory Intelligence into Practice
Industry leaders from Medtronic, Smith+Nephew, and Redica will discuss how regulatory intelligence programs can streamline key information. Discover use cases for optimizing these programs and tips to drive greater business value.
Darren Thain
RA Director, Global Regulatory Intelligence and Policy
Smith+Nephew
With 10+ years experience in various regulatory and quality roles, Darren is currently responsible for regulatory affairs for global policy and intelligence across all franchises at Smith+Nephew. He previously held roles with small and large organizations in medical device, pharmaceutical, and animal materials covering various product technologies. Darren also served as Director of European Regulatory Affairs and Commercial Quality and was EU MDR Regulatory lead for the Wound franchise within Smith+Nephew.
Sessions
Medtronic and Smith+Nephew: Putting Regulatory Intelligence into Practice
Tuesday, 29 April
12:30 CT
Darren Thain
RA Director, Global Regulatory Intelligence and Policy
Smith+Nephew
Alison Sathe
SVP Data Strategy & Analytics
Redica Systems
At Redica Systems, as Senior Vice President of Data Strategy & Analytics, Alison leverages extensive data sources and artificial intelligence with real-time compliance monitoring to enhance regulatory intelligence in the life sciences industries. Alison brings her executive experience in Regulatory Affairs, including expertise in global regulatory compliance, quality system implementation, and market-entry strategies, to Redica Systems to enable powerful data and analytics for pharmaceutical and medical device firms to excel in dynamic regulatory environments.
Sessions
Medtronic and Smith+Nephew: Putting Regulatory Intelligence into Practice
Tuesday, 29 April
12:30 CT
Alison Sathe
SVP Data Strategy & Analytics
Redica Systems
Syed Sumran Mohiuddin
Regulatory Affairs Director
Medtronic
Syed has been with Medtronic for 17 years. He started as a regulatory affairs (RA) specialist in 2008 where he served as the regulatory subject matter expert for CRM’s portfolio of cardiovascular implantable device programmers. In 2021, Syed joined the CRM RA leadership staff and in 2024, he joined the RA department within Medtronic's surgical operating unit (SOU), where he serves as leader of the digital technologies RA team.
Sessions
Medtronic and Smith+Nephew: Putting Regulatory Intelligence into Practice
Tuesday, 29 April
12:30 CT
Syed Sumran Mohiuddin
Regulatory Affairs Director
Medtronic
Cardinal Health: 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
Cardinal Health: Modernizing Recall Management for Safer Patient Outcomes
Tuesday, 29 April
12:30 CT
Janna Parks
VP, Quality Compliance & Governance
Cardinal Health
Paul Sumner
Former Head of Manufacturing, Innovation and Quality
MDIC
Paul Sumner brings senior executive leadership and international consulting experience in regulatory affairs, quality assurance, and compliance across Fortune 5 medical technology firms. He has published and taught on FDA, DOJ, and medical device regulations, healthcare compliance, and quality systems, along with drafting regulatory policy and legislative language. As an accomplished presenter and trainer, he covers medical device regulations, laws, and key topics shaping the industry.
Sessions
Cardinal Health: Modernizing Recall Management for Safer Patient Outcomes
Tuesday, 29 April
12:30 CT
Paul Sumner
Former Head of Manufacturing, Innovation and Quality
MDIC
Baxter: Considerations for AI in Marketing Execution
Baxter 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
GE HealthCare: Aligning Medical Strategy with Organizational Goals
Learn how GE Healthcare's medical strategy aligns with their organizational goals and how customer engagement is a key component. Discover tactics to growing a medical affairs organization, key initiatives and selling value to the broader organization.
Dr. Dustin M. Dunham
Head of Medical Affairs, Americas
GE HealthCare | Pharmaceutical Diagnostics
Dustin Dunham is a board-certified clinician, executive MBA, and Medical Affairs strategist with 20+ years of combined pharmaceutical, medical device, and clinical experience. Dustin serves as Head of Medical Affairs for GE HealthCare’s Pharmaceutical Diagnostics organization, providing leadership to the Medical Information function, Americas’ regional field medical teams, and diagnostic care pathways. Dustin is a Board Certified Medical Science Liaison, Board Certified Medical Affairs Specialist, Board Certified Biologics & Biosimilars Specialist, Board Certified Patient Advocate, Fellow of the Accreditation Council for Medical Affairs, Fellow of the Royal Society for Public Health, and Fellow of the American College of Health Data Management.
Sessions
GE HealthCare: Aligning Medical Strategy with Organizational Goals
Tuesday, 29 April
12:30 CT
Dr. Dustin M. Dunham
Head of Medical Affairs, Americas
GE HealthCare | Pharmaceutical Diagnostics
Melissa Napier
Associate Medical Director of Radiology
GE HealthCare
Melissa Napier supports global R&D in MRI pipeline product development at GE HealthCare. She started her career as a cardiothoracic ICU nurse, shifted to the pharma side with the AstraZeneca CV and metabolic team, and then moved into medical affairs as a medical science liaison. She is passionate about investigator initiated studies, real world evidence, radiology congress support, KOL relationship and collaborations, and driving lean, innovative solutions.
Sessions
GE HealthCare: Aligning Medical Strategy with Organizational Goals
Tuesday, 29 April
12:30 CT
Melissa Napier
Associate Medical Director of Radiology
GE HealthCare
1:15 — 2:30
CT
Networking Lunch
2:10 — 2:30
CT
Innovation Theater - eCOA
Learn how Veeva eCOA simplifies design, management, and completion of clinical outcomes assessments for patients, sponsors and sites.
2:45 — 3:30
CT
Connecting Clinical Operations and Data to Accelerate Study Timelines - 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 BD 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.
Montoya Love
Director Regulatory Compliance
Becton Dickinson (BD)
With 15 years in the pharmaceutical industry, 5 years in advertising, and 5 years in clothing manufacturing, Montoya has dedicated most of her 20+ year career to IT. Early in her career, she worked on HR systems, benefits, and payroll on a global scale. At Becton Dickison, Montoya manages the operations of the Advertising and Promotion program, ensuring the system meets the needs of its 2,200 users worldwide. She is also spearheading an exciting new initiative that leverages AI to streamline the Ad Promo process in PromoMats, making the MLR process more efficient for approvers. Additionally, Montoya is focused on implementing the Veeva RIM Regulatory Submissions and integrating this application into BD's Regulatory landscape.
Sessions
BD: Maximizing the Potential of Claims
Tuesday, 29 April
2:45 CT
Montoya Love
Director Regulatory Compliance
Becton Dickinson (BD)
Enrique Carlos
Digital Delivery Director
BD
Enrique has 15+ years of experience building digital customer experiences across consumer goods, technology, electronics, and real estate. At BD, Enrique drives digital standards, capabilities, and campaigns at scale. His AI initiative streamlines content creation, enabling marketers to generate high-quality content in minutes.
Sessions
BD, Exact Sciences, & Teleflex: Future of Commercial & Medical Affairs
Tuesday, 29 April
9:45 CT
BD: Maximizing the Potential of Claims
Tuesday, 29 April
2:45 CT
Enrique Carlos
Digital Delivery Director
BD
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.
Edwards: Best Practices in Customer Engagement Strategies
In this session, Edwards share how they leverage their GTM strategy through KOL management and their role in partnering across the entire organization. Learn congress planning strategies and identifying new KOLs to meet business needs.
Carlos Paret
Medical Affairs Director - Operations
Edwards Lifesciences
As Director Medical Affairs, Carlos leads U.S. Operations for Transcatheter Heart Valves at Edwards Lifesciences. He is currently transforming the impact of Edwards' U.S. physician proctor program, physician training, and best-in-class tele-proctoring. His team led the digital evolution of physician training, including launching CathlabVR and next generation simulation-based training. His 2024 focus includes launching the Global HCP Engage Portal and flawless global introduction of Veeva Link Key People for MedTech and Link Workflow 2.0.
Sessions
Edwards: Best Practices in Customer Engagement Strategies
Tuesday, 29 April
2:45 CT
Carlos Paret
Medical Affairs Director - Operations
Edwards Lifesciences
Sandie Dela Cruz
Sr. Manager, Digital Solutions Medical Affairs
Edwards Lifesciences
Sandie Dela Cruz is a digital solutions leader at Edwards Lifesciences, driving operational excellence and enhancing efficiency by leading complex digital transformation projects and leveraging advanced technologies such as AI and learning management systems. Sandie has over a decade of experience in the healthcare sector, holding a doctor of science in audiology and an MBA. Sandie collaborates with stakeholders to align product strategies with market demands, championing the integration of "voice of customer" insights into product development.
Sessions
Edwards: Best Practices in Customer Engagement Strategies
Tuesday, 29 April
2:45 CT
Sandie Dela Cruz
Sr. Manager, Digital Solutions Medical Affairs
Edwards Lifesciences
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 accelerated study development and streamlined data collection for faster and more efficient product approvals with the support of Veeva EDC.
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.
Getting the Most Out of Reports and 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.
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
Learn more about Veeva's first LLM-developed solution that drives MLR efficiency with upstream quality checks and seamless marketing content review.
5:10 — 5:30
CT
Innovation Theater - Link
Learn how Veeva Link Key People can help teams ease the burden of congress planning, identify new and emerging experts, and stay up to date on expert trends.
6:30 — 10:30
CT
Evening Event - Moontower Saloon
Wednesday, 30 April
8:00 — 9:00
CT
Networking Breakfast
8:30 — 8:50
CT
Driving Efficiency with Digital Validation
Discover how to reduce validation lifecycle times by up to 70% with Veeva Validation Management. Learn how a digital approach streamlines commissioning, qualification, and validation across computerized systems, facilities, utilities, equipment, and processes.
Innovation Theater - Image Management
See how the unification of image management with EDC simplifies data capture.
9:00 — 9:45
CT
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.
Alcon and Merit: Evaluating AI in Regulatory Affairs
There is increasing interest in AI use cases for medtech regulatory affairs, but can AI really replace humans on core tasks? This session will explore how Alcon and Merit Medical are thinking about AI tools, governance, and potential benefits as part of broader digital transformation initiatives.
Bryan Hunt
Senior Director, Digital Quality and Regulatory Affairs
Alcon
Bryan currently heads the global digital quality and regulatory affairs organization, overseeing QRA applications, data & analytics, and e-compliance across the Alcon enterprise. His experience spans both pharma and med device in the areas of AI-driven compliance, data governance, and cloud-based quality solutions. Prior to Alcon, he held positions with Hewlett-Packard, Agilent Technologies, and within the Novartis group of companies.
Sessions
Alcon and Merit: Evaluating AI in Regulatory Affairs
Wednesday, 30 April
9:00 CT
Alcon and PwC: Innovating Quality Management with Advanced Technologies and AI
Wednesday, 30 April
10:00 CT
Bryan Hunt
Senior Director, Digital Quality and Regulatory Affairs
Alcon
Cory Marsh
Director, Regulatory Affairs Operations
Merit Medical Systems, Inc.
An attorney by education, Cory has experience in regulatory compliance and submissions, strategic planning, continuous improvement, and business excellence. He began his regulatory affairs career 15 years ago in medical device submissions and has evolved into regulatory operations. Cory is currently leading the Merit RA operations group, supporting global regulatory business excellence across eight manufacturing sites, and hundreds of product lines.
Sessions
Alcon and Merit: Evaluating AI in Regulatory Affairs
Wednesday, 30 April
9:00 CT
Cory Marsh
Director, Regulatory Affairs Operations
Merit Medical Systems, Inc.
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.
Smith+Nephew: Strengthening Supplier Quality for Resilience and Innovation
Supply chain disruptions, material shortages, and evolving regulations challenge medtech companies to maintain quality while scaling supplier networks. Hear Smith+Nephew share best practices for supplier qualification, monitoring, and collaboration that drive supply chain resilience, product integrity, and innovation.
Scott Dauphinee
Sr. Director of Supplier Quality
Smith+Nephew
Scott brings over 25 years of experience in the medical device and automotive industries to his role as the head of supplier quality at Smith+Nephew. He leads a global team responsible for wound management, sports medicine, and orthopedics, overseeing supplier selection, onboarding, and performance management.
As a seasoned professional with a proven track record in both industries, Scott is uniquely positioned to drive strategic relationships, foster accountability, and promote a continuous improvement mindset among Smith+Nephew's suppliers. His expertise and leadership ensure the highest standards of quality and innovation in the company's supply chain."
Sessions
Smith+Nephew: Strengthening Supplier Quality for Resilience and Innovation
Wednesday, 30 April
9:00 CT
Scott Dauphinee
Sr. Director of Supplier Quality
Smith+Nephew
Smith+Nephew: Intersection of Clinical and Medical, a Data-driven Path Forward
Smith+Nephew will discuss the role of safety within clinical and medical affairs, including how to modernize collaboration, processes, and operations to ensure a data driven approach aligned to requirements.
Matt Christensen
SVP Global Clinical & Medical Affairs
Smith+Nephew
Matt brings more than 25 years in the medical device industry to his role as an executive leader at Smith+Nephew. He currently leads a global team and is responsible for generating, analyzing, and communicating evidence to expedite new product approval, expand market adoption and maintain product access in key markets.
Sessions
Smith+Nephew: Intersection of Clinical and Medical, a Data-driven Path Forward
Wednesday, 30 April
9:00 CT
Closing Keynote: Unifying for Safety - How Clinical, Quality, and Medical Affairs Drive Patient Protection
Wednesday, 30 April
11:30 CT
Matt Christensen
SVP Global Clinical & Medical Affairs
Smith+Nephew
10:00 — 10:45
CT
Exact Sciences, Medtronic, and Zeiss: Fostering Diversity in Clinical Trials
Diverse clinical trials are essential for developing safe and effective treatments for all populations. Learn how Exact Sciences, Medtronic, and Zeiss 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
Exact Sciences, Medtronic, and Zeiss: 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
Exact Sciences, Medtronic, and Zeiss: 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
Exact Sciences, Medtronic, and Zeiss: Fostering Diversity in Clinical Trials
Wednesday, 30 April
10:00 CT
Paul Swift
Head of RA/CA, Americas
Carl Zeiss Meditec
Cook Medical: 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 Cook Medical structured their RIM implementations, supported by change champions and a full change management program.
Ann Sturgill
Director, Regulatory Affairs Operations
Cook Medical
Ann Sturgill has lead the Veeva RIM implementation at Cook Medical since March 2020, including the identification, development, communication, and coordination of all regulatory affairs (RA) processes and systems. She is responsible for the continuous improvement and monitoring of RA processes to ensure they align with the objectives of the global regulatory function. Currently, Cook Medical is undergoing a digital transformation, which includes the global standardization of all RA processes and procedures.
Sessions
Cook Medical: Empowering Change Champions for a Global RIM Rollout
Wednesday, 30 April
10:00 CT
Ann Sturgill
Director, Regulatory Affairs Operations
Cook Medical
Alcon and PwC: Innovating Quality Management with Advanced Technologies and AI
Discover how Alcon's real-world innovations and PwC’s AI best practices are driving quality improvements. Learn how strategic alignment, technology adoption, and practical applications deliver greater efficiency and innovation.
Sam Venugopal
Partner
PwC - Pricewaterhouse Coopers
Sam brings over 30 years of experience delivering value-driven solutions in quality systems, regulatory compliance, supply chain, and IT across the biotechnology, pharmaceutical, and medical device industries. As a trusted advisor to the FDA, Sam has collaborated with CDER to help Industry improve compliance while leveraging quality as a driver of operational efficiency, contributing to case studies that illustrate quality by design principles.
Sessions
Alcon and PwC: Innovating Quality Management with Advanced Technologies and AI
Wednesday, 30 April
10:00 CT
Sam Venugopal
Partner
PwC - Pricewaterhouse Coopers
Bryan Hunt
Senior Director, Digital Quality and Regulatory Affairs
Alcon
Bryan currently heads the global digital quality and regulatory affairs organization, overseeing QRA applications, data & analytics, and e-compliance across the Alcon enterprise. His experience spans both pharma and med device in the areas of AI-driven compliance, data governance, and cloud-based quality solutions. Prior to Alcon, he held positions with Hewlett-Packard, Agilent Technologies, and within the Novartis group of companies.
Sessions
Alcon and Merit: Evaluating AI in Regulatory Affairs
Wednesday, 30 April
9:00 CT
Alcon and PwC: Innovating Quality Management with Advanced Technologies and AI
Wednesday, 30 April
10:00 CT
Bryan Hunt
Senior Director, Digital Quality and Regulatory Affairs
Alcon
Axogen and CooperSurgical: 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 Axogen and other industry leaders on strategies, lessons learned, and innovative approaches to delivering successful product launches in dynamic global markets.
Rosetta Mazzei
Promotional Advertising Review Committee Leader
CooperSurgical
Rosetta manages promotional advertising content through approval process and develops best practices for a streamlined approach to claims implementation and management. As a leader she oversees SOP development, management of cross-functional review teams and training for content approval and distribution.
Sessions
Axogen and CooperSurgical: Aligning Teams for Global Product Launch Success
Wednesday, 30 April
10:00 CT
Rosetta Mazzei
Promotional Advertising Review Committee Leader
CooperSurgical
Anna Lane
Senior Director, Marketing Communications
Axogen
With over 20 years of experience, Anna leads patient and HCP marketing, digital campaigns, brand experience, and public relations. She is also guiding Axogen’s transition from a medical device to a biologic, ensuring pharma-compliant messaging. Passionate about connecting patients and healthcare providers, Anna is dedicated to transforming healthcare marketing for those with nerve injuries.
Sessions
Axogen and CooperSurgical: Aligning Teams for Global Product Launch Success
Wednesday, 30 April
10:00 CT
Anna Lane
Senior Director, Marketing Communications
Axogen
Solventum: Optimizing Medical Communication and Inquiries
Solventum 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.
Ricardo Martinez
Medical Information and Publications Leader
Solventum
With over 34 years of experience in the medical device industry, Ricardo has served in several roles, including scientist, inventor, regulatory officer, and medical writer. Currently, he facilitates the creation of essential medical and scientific publications, ensuring that healthcare professionals (HCPs) and internal Solventum partners have access to high-quality medical information and presentations.
Sessions
Solventum: Optimizing Medical Communication and Inquiries
Wednesday, 30 April
10:00 CT
Ricardo Martinez
Medical Information and Publications Leader
Solventum
10:45 — 11:30
CT
Connect Break
11:00 — 11:20
CT
Innovation Theater - Quality Audit Room
Get a live look at Quality Audit Room, streamlining collaboration and efficiency in audit execution.
11:30 — 12:15
CT
Closing Keynote: Unifying for Safety - How Clinical, Quality, and Medical Affairs Drive Patient Protection
Leaders from Smith+Nephew and Teleflex will discuss the role of clinical, quality, and medical affairs in driving patient protection.
Matt Christensen
SVP Global Clinical & Medical Affairs
Smith+Nephew
Matt brings more than 25 years in the medical device industry to his role as an executive leader at Smith+Nephew. He currently leads a global team and is responsible for generating, analyzing, and communicating evidence to expedite new product approval, expand market adoption and maintain product access in key markets.
Sessions
Smith+Nephew: Intersection of Clinical and Medical, a Data-driven Path Forward
Wednesday, 30 April
9:00 CT
Closing Keynote: Unifying for Safety - How Clinical, Quality, and Medical Affairs Drive Patient Protection
Wednesday, 30 April
11:30 CT
Matt Christensen
SVP Global Clinical & Medical Affairs
Smith+Nephew
Michelle Fox
Corporate Vice President and Chief Medical Officer
Teleflex Inc
Michelle Fox and her leadership team set the clinical vision and strategy for Teleflex. She helps guide both medical affairs to assure compliance with global regulatory, legislative, and medical requirements and clinical affairs to implement multidisciplinary clinical development programs covering a broad range of products and therapeutic areas. Michelle also leads the scientific, clinical research and market access, reimbursement, and health policy arm of the organization. She is particularly passionate about sustainable healthcare, health equity, diversity equity, and inclusion and holds a position on the respective global councils.
Sessions
BD, Exact Sciences, & Teleflex: Future of Commercial & Medical Affairs
Tuesday, 29 April
9:45 CT
Sequel & Teleflex CMOs Talk Mapping the Medical Affairs Landscape
Tuesday, 29 April
11:30 CT
Closing Keynote: Unifying for Safety - How Clinical, Quality, and Medical Affairs Drive Patient Protection
Wednesday, 30 April
11:30 CT
Michelle Fox
Corporate Vice President and Chief Medical Officer
Teleflex Inc
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
11:30 CT
Closing Keynote: Unifying for Safety - How Clinical, Quality, and Medical Affairs Drive Patient Protection
Wednesday, 30 April
11:30 CT
Michael Jacene
VP of Quality
Smith+Nephew
12:15 — 1:30
CT
Networking Lunch
1:00 — 1:20
CT
Innovation Theater - Scientific Communication Management
Learn how Veeva MedComms drives approval speed and accuracy of scientific communications.
