Join us for a Welcome Reception 6-7pm on the sixth floor foyer followed by dinner 7-9pm in the Grand Ballroom at the Hilton Austin.
Tuesday, April 30
7:30a.m. — 8:30a.m.
CT
Networking Breakfast
8:45a.m. — 9:30a.m.
CT
Opening Keynote
Hear the latest innovations and new product announcements, including how to streamline the total product lifecycle.
9:45a.m. — 10:30a.m.
CT
Better Clinical Data to Decrease Site and Sponsor Burden and Increase Compliance
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
Christy leads BDs data management team responsible for producing high-quality databases that meet customer requirements and regulatory compliance standards. She has over 23 years experience managing clinical data for global trials across various therapeutic areas and phases, using advanced tools and techniques such as master protocol and electronic data capture. Her core competencies include data integrity, innovative study design, data analysis, information delivery, and strategic planning.
Sessions
Better Clinical Data to Decrease Site and Sponsor Burden and Increase Compliance
Tuesday, 30 April
9:45 CT
Christy Zeigler
Director, Clinical Data Management
BD
Kelley Crist
Director, Clinical Data Management
BD
Kelley has more than 25 years experience in clinical data management in pharma and biotech for both Sponsors and CROs. As Director of Clinical Data Management at BD, she is responsible for leading a team of clinical data managers and manages Veeva CDMS and CDB applications. Currently her team is focused on migrating BDs multiple CDMS platforms into a single source - Veeva CDMS/CDB - to enhance efficiency and reduce waste.
Sessions
Better Clinical Data to Decrease Site and Sponsor Burden and Increase Compliance
Tuesday, 30 April
9:45 CT
Kelley Crist
Director, Clinical Data Management
BD
Vanessa Fulginiti
Sr. Clinical Systems Architecture Specialist
BD
A key member of Global Medical Affairs at BD, Vanessa is responsible for executing innovative and interoperable clinical system initiatives, including architecting object-focused clinical systems to simplify and transform clinical operations and clinical data management. In 2023 she led the strategy and rollout for the successful implementation of Vault Payments in partnership with Veeva. She is motivated by delivering technical solutions to improve operational efficiency and empower users.
Sessions
Better Clinical Data to Decrease Site and Sponsor Burden and Increase Compliance
Tuesday, 30 April
9:45 CT
Vanessa Fulginiti
Sr. Clinical Systems Architecture Specialist
BD
Best Practices for Vault RIM Migration and Implementation
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 Evolving Role of Quality
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
Steve has more than 30 years of quality and regulatory affairs experience including executive leadership roles in global companies across the medical device and invitro diagnostics industries. Prior to joining Philips as Chief Patient Safety and Quality Officer, he served as EVP of QA/RA for Cardinal Health, as well as holding executive leader roles with Zimmer Biomet, Danaher Diagnostic, and Boston Scientific.
Additionally, Steve served as an industry board member and instructor for six years for the regulatory affairs master’s degree program at St. Cloud State University. He earned a bachelor’s degree in engineering and industrial technology and MBA, both at California State University Long Beach.
Sessions
The Evolving Role of Quality
Tuesday, 30 April
9:45 CT
Steve C de Baca
Chief Patient Safety and Quality Officer
Philips
Nidia Acevedo
Sr. Vice President, Global Quality Compliance
Eli Lilly and Company
Nidia began her career as a consumer safety officer with the US Food & Drug Administration. She went on to hold positions with increasing responsibilities at various multi-national pharmaceutical companies, including quality leadership roles for manufacturing operations. Nidia has a broad range of quality experiences across bulk drug substance, parenteral drug products, and packaging operations, as well as research and development, quality, and regulatory affairs.
In her most recent experience before joining Lilly in 2022, Nidia was a quality executive at a biotech company where she previously served as in-house counsel and dotted line reported to the chief ethics and compliance officer.
Nidia holds a bachelor’s degree in industrial microbiology and a juris doctor from the University of Puerto Rico. She also holds master’s and doctorate degrees that from the Complutense University School of Law.
Sessions
The Evolving Role of Quality
Tuesday, 30 April
9:45 CT
Nidia Acevedo
Sr. Vice President, Global Quality Compliance
Eli Lilly and Company
Building an Effective Promotional Claims Management Approach
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
Christina has more than 25 years of experience overseeing clinical, health economics and outcomes research, and preclinical research conducted by industry, contract research organizations, academia, and non-governmental organizations. She is also an agile process expert in clinical, medical, quality and audit functions. Christina has led clinical, data management and biostatistics, clinical compliance and audit teams ensuring a flexible model to achieve agility while ensuring compliance. By partnering with international regulatory authorities, she's helped develop and implement training initiatives in multiple areas.
Sessions
Building an Effective Promotional Claims Management Approach
Tuesday, 30 April
9:45 CT
Transforming Claims, Evidence, and Substantiation
Wednesday, 1 May
9:00 CT
Christina Villar
Head Clinical Affairs
Philips
Valeria Bogomolnaya
Marketing Claims Specialist
Philips
Valeria is a marketing claims specialist with Philips Hospital Patient Monitoring organization and currently leads implementation of Vault PromoMats across HPM. She has over 15 years experience in operations, international relations, and marketing and is adept at working with cross-functional teams.
Sessions
Building an Effective Promotional Claims Management Approach
Tuesday, 30 April
9:45 CT
Valeria Bogomolnaya
Marketing Claims Specialist
Philips
Proactively Managing Your Vault
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
Todd is an IT professional with 29 years of experience, 20 of those with Alcon, the world leader in eye care. His focus has been implementation and support of enterprise applications spanning ERP, manufacturing, distribution and R&D.
Sessions
Proactively Managing Your Vault
Tuesday, 30 April
9:45 CT
Todd Steppick
Director, DevOps, Integrations and AMS
Alcon
Justin Janda
Director, R&D IT, Clinical Systems
Alcon
Justin has 20 years of experience across various business and IT roles at Alcon, the world leader in eye care. In his current role, he focuses on partnering with Alcon's Clinical Research & Development organization supporting all IT needs.
Sessions
Proactively Managing Your Vault
Tuesday, 30 April
9:45 CT
Justin Janda
Director, R&D IT, Clinical Systems
Alcon
One Avita: A Single Source of Truth for HCP Intelligence
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
Brad Wiggins brings over 35 years of dedicated experience in burn care to his current role as Director of Professional Relations at AVITA Medical. He is an advocate for patients and recognized leader in the field, having dedicated three decades of his career to the University of Utah Hospital's Burn Center. He leverages this knowledge to develop impactful professional education events at AVITA Medical, fostering strong relationships with key opinion leaders and advancing quality burn care.
Sessions
One Avita: A Single Source of Truth for HCP Intelligence
Tuesday, 30 April
9:45 CT
Brad Wiggins
Director of Professional Relations
AVITA Medical
10:30a.m. — 11:00a.m.
CT
Connect Break
11:00a.m. — 11:45a.m.
CT
Building a Collaborative Ecosystem for Sponsors and Clinical Trial Sites
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
Shannon specializes in Clinical Operations Systems and has 15 years’ experience in managing and supporting CTMS and eTMF. She currently manages 4 teams providing operations support for Medtronic Sponsored clinical trials, which includes CTMS, eTMF, Vendor Management and Forecasting. In February 2023 she led a successful implementation of eTMF- eISF framework in partnership with Veeva.
Sessions
Building a Collaborative Ecosystem for Sponsors and Clinical Trial Sites
Tuesday, 30 April
11:00 CT
Shannon Amore
Sr. Systems Enablement Manager
Medtronic
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
Building a Collaborative Ecosystem for Sponsors and Clinical Trial Sites
Tuesday, 30 April
11:00 CT
Matt Christensen
SVP Global Clinical & Medical Affairs
Smith+Nephew
Medtech Regulatory Roundup
Don't miss out on the latest updates in the MedTech regulatory landscape. Industry experts from Solventum and Veeva will share key insights on the complex regulatory environment including EU MDR, eSTAR, UDI, global harmonization, and real world evidence.
Aligning Quality Transformation with Business Priorities
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
Elizabeth is a clinical laboratory scientist with more than 30 years of experience at Bio-Rad Laboratories in global regulatory submissions and clinical study management. As vice president of global regulatory & clinical affairs, Elizabeth leads a global team of professionals based in 16 countries that support a large portfolio of IVD products. Bio-Rad is currently undergoing eQMS transformation to implement Vault QualityDocs, QMS, and eTMF clinical operations modules.
Sessions
Aligning Quality Transformation with Business Priorities
Tuesday, 30 April
11:00 CT
Navigating Regulatory Landscapes: QA/RA Global Harmonization Strategies
Wednesday, 1 May
9:00 CT
Elizabeth Platt
Vice President, Regulatory & Clinical Affairs
Bio-Rad Laboratories
Kerry Lovejoy
Director, QA/RA/CA PMO & Quality Integrations
Bio-Rad Laboratories
Kerry is a quality & regulatory professional with over 20 years of experience leading compliance, operational, and business transformation initiatives. She has led implementation of QMS processes and tools in the biotech, pharmaceutical, and medical device industries. Currently, Kerry is heading up the QARA Project Management Organization at Bio-Rad and actively driving global QMS transformation efforts.
Sessions
Aligning Quality Transformation with Business Priorities
Tuesday, 30 April
11:00 CT
Kerry Lovejoy
Director, QA/RA/CA PMO & Quality Integrations
Bio-Rad Laboratories
Evolving Medical Affairs: A Modern Approach to Medical Content and Inquiry Management
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
As the Director of Medical Information at BD, Cassie manages the team responsible for addressing customer inquiries regarding BD products and the procedures in which they are used. Her team utilizes Vault Medical globally to provide consistent, approved responses to customers while providing valuable insights back to the business.
Sessions
Evolving Medical Affairs: A Modern Approach to Medical Content and Inquiry Management
Tuesday, 30 April
11:00 CT
Cassie Singleton
Director, Medical Information
BD
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.
12:00p.m. — 12:45p.m.
CT
Real-world Data Standardization to Drive Interoperability
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, Standards Development
CDISC
Jon has extensive experience with both developing and implementing CDISC standards and has led, co-led, or participated in many CDISC standards development projects spanning more than a dozen therapeutic areas. He has a particular interest in data standards for genetics and imaging biomarkers, including data modeling around the relationship between findings on imaging and the imaging device. He also serves on the CDISC Global Governance Group and provides oversight on multiple volunteer-led CDISC teams.
Sessions
Real-world Data Standardization to Drive Interoperability
Tuesday, 30 April
12:00 CT
Jon Neville
Senior Director, Standards Development
CDISC
Pipper White
Senior Program Manager
MDIC
Pipper is responsible for the overall management of projects under MDIC's Clinical Diagnostics program and is leading the IVD Data Standardization initiative. As a public-private partnership, MDIC is working with manufacturers, standards organizations, and regulators to develop clinical study data standards for regulatory submission. She is also a certified clinical engineer with over 20 years experience managing medical equipment technology and has earned a MSc in Medical Electronics and a BS in Biomedical Engineering.
Sessions
Real-world Data Standardization to Drive Interoperability
Tuesday, 30 April
12:00 CT
Pipper White
Senior Program Manager
MDIC
Holistic Data Management: The Key to UDI Compliance and Beyond
With a constantly evolving landscape, medtech companies are starting to take a holistic data management approach to stay ahead of the latest regulations. In this session, you'll learn how to drive success beyond regulatory requirements with practical insights and strategies for effective UDI compliance.
Jay Crowley
VP, Medical Devices
USDM Life Sciences
Jay is currently VP of Medical Device Solutions and Services at USDM Life Sciences. Prior to joining the firm in 2014, he was Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health. He held a variety of positions over his nearly 27 years at FDA. Jay had primary responsibility for the development and implementation of FDA’s Unique Device Identification System and the development of the GHTF and IMDRF UDI guidance documents.
Sessions
Holistic Data Management: The Key to UDI Compliance and Beyond
Tuesday, 30 April
12:00 CT
Jay Crowley
VP, Medical Devices
USDM Life Sciences
Launching a Quality Transformation Program
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.
Meagan is a quality systems professional with 12 years of experience working in regulated medical device and pharmaceutical manufacturing with companies such as Thermo Fisher Scientific, Baxter and CSL (previously Novartis). During that time she has worked to establish and maintain quality system compliance to written processes and procedures and applicable standards and regulations. She previously held positions as a senior quality systems manager, quality systems auditor, and quality engineer.
Sessions
Launching a Quality Transformation Program
Tuesday, 30 April
12:00 CT
Meagan Zack
Program Manager
Teleflex Inc.
Adapting Global Marketing Assets for Local Market Success
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
Stephanie is Senior Manager Global Marketing Innovation at Johnson & Johnson where she manages the copy approval process for J&J MedTech Vision across all regions. She is also the Vault PromoMats owner. Stephanie has 15 years experience in the Pharmaceutical and MedTech sectors.
Sessions
Adapting Global Marketing Assets for Local Market Success
Tuesday, 30 April
12:00 CT
Stephanie Carter
Promotional Integrity Manager
Johnson & Johnson MedTech - Vision
Medical Affairs Transformation: It's a Journey
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
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
Medical Affairs Transformation: It's a Journey
Tuesday, 30 April
12:00 CT
Dr. Dustin M. Dunham
Head of Medical Affairs, Americas
GE HealthCare | Pharmaceutical Diagnostics
Christine Brand
Medical Director - Oncology, Care Area Lead
GE HealthCare
Christine, MPA graduated in Nuclear Medicine Technology from University of Iowa and then earned a Master of Public Administration from Drake University. She is a Medical Director and Care Area Lead for Oncology at GE HealthCare Pharmaceutical Diagnostics where she also chairs a global Medical Affairs digital transformation team. As a medical affairs professional, she leads this global team as well as a regional field team to focus on efficiently & effectively informing GE HealthCare through bidirectional scientific engagement and clinical mindshare with healthcare providers, institutions and medical societies.
Sessions
Medical Affairs Transformation: It's a Journey
Tuesday, 30 April
12:00 CT
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
Strategic Clinical Research Considerations from MedTech CROs
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
Jodi Mullin has worked in the medical device industry for over 13 years, with experience
spanning a diverse array of therapeutic areas including cardiology, oncology, and urology. She has worked with startups to Fortune 500 companies, partnered with clinical technology
providers, and spearheaded cross-functional process improvement initiatives.
Jodi has extensive experience with Site management from selection to close-out, including
onsite, remote and risk-based monitoring. She is a Certified Clinical Research Associate and
member of the Association of Clinical Research Professionals.
In addition to managing NAMSA’s Global Clinical Trial Administrator team, Jodi is part of
NAMSA’s electronic Trial Master File (eTMF) technical team and recently led the
reimplementation of Veeva eTMF.
Sessions
Strategic Clinical Research Considerations from MedTech CROs
Tuesday, 30 April
13:45 CT
Jodi Mullin
Manager, Clinical Operations
NAMSA
Robin Solinsky
Director of Clinical Data Systems
Bright Research
Robin Solinsky is the Director of Clinical Data Systems at Bright Research, a small and mighty CRO based in, downtown Minneapolis. She has lead study designs, trial execution, and all data management at Bright since 2015. Prior to Bright Research, Robin independently consulted for nearly a decade at a variety of medical device companies. She started as a quality engineer after graduating with a BS in biomedical engineering from the University of Minnesota.
Sessions
Strategic Clinical Research Considerations from MedTech CROs
Tuesday, 30 April
13:45 CT
Robin Solinsky
Director of Clinical Data Systems
Bright Research
Emily Friedland
VP of Clinical Research
DCN Dx
Emily has 25 year experience in IVD clinical research at sponsor organizations including Roche Molecular Systems, Cepheid, Novartis Vaccines & Diagnostics, Singulex, and Teleflex. In 2021, she joined DCN Dx as VP of Clinical Research to add and lead full clinical research services for IVD to their existing offerings, which include R&D, manufacturing, and engineering services for Lateral Flow Assays. DCN Dx offers clinical research services to IVD manufacturers including point-of-care, over-the-counter, CLIA-waived and moderate to high complexity CLIA laboratory devices.
Sessions
Strategic Clinical Research Considerations from MedTech CROs
Tuesday, 30 April
13:45 CT
Emily Friedland
VP of Clinical Research
DCN Dx
Recognizing Excellence with the Full Vault RIM Platform
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
Greg has 30+ years of experience and has been with Alcon for 14 years, the world leader in eye care. His focus has been business partnering and support of enterprise applications supporting commercial, quality and R&D.
Sessions
Recognizing Excellence with the Full Vault RIM Platform
Tuesday, 30 April
13:45 CT
Greg White
IT Director Regulatory, Medical & Veeva Quality
Alcon
Vault Quality Product Roadmap
See the latest Vault Quality innovations to bring speed and simplicity to critical quality processes, including complaint handling, audits, learning management, and more.
Commercial Content Product Roadmap
See the latest Vault PromoMats content innovations to simplify the user experience, increase speed, and enable reuse with modular content.
Bridging the Gap between Business and IT
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
Dave leads the global technology solution transformations team at Glaukos. He works to align business and technology needs to meet growing organizational requirements, focusing on nimble and effective solutions
Sessions
Bridging the Gap between Business and IT
Tuesday, 30 April
13:45 CT
David Hohler
Sr. Director, Global Technology Solutions
Glaukos
Transforming KOL Engagement with Data and Software
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
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
Transforming KOL Engagement with Data and Software
Tuesday, 30 April
13:45 CT
Carlos Paret
Medical Affairs Director - Operations
Edwards Lifesciences
2:45p.m. — 3:30p.m.
CT
Link Key People Product Roadmap
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.
Vault Clinical Data Product Roadmap
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 Vault RIM product team will highlight key features from the past year along with exciting new functionality across Registrations, Submissions, Publishing, and Archive. They'll also provide a detailed roadmap for optimizing the overall Vault RIM experience.
A Risk-based Approach: Best Practices from FDA on Case for Quality & Computer Software Assurance
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
Daniel is a member of the Case for Quality team in CDRH’s compliance and quality Staff. He has been with FDA for 15 years in a variety of roles, most notably as a branch chief for cardiovascular devices in the Office of Compliance, and as an assistant director for obesity and hepatobiliary devices in OHT3. Prior to FDA, Daniel was a validation specialist for eight years in the pharmaceutical industry.
Sessions
A Risk-based Approach: Best Practices from FDA on Case for Quality & Computer Software Assurance
Tuesday, 30 April
14:45 CT
Daniel Walter
Policy Analyst
FDA
Unpacking Periodic Content Review
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
As group marketing manager, Natalya champions Abbott’s high-powered brand across the vascular portfolio, driving creative consistency and clear communication across the globe. Through her passion to bring digital capabilities to life, Natalya has pioneered patient education tools to support cath lab discharge processes. She also spearheaded a virtual events platform adoption across the regions and currently leads the worldwide integration of Vault PromoMats to reach a new level of marketing compliance. Natalya leads high achieving cross-functional teams, identifying and developing top talent in the organization.
Sessions
Unpacking Periodic Content Review
Tuesday, 30 April
14:45 CT
Natalya Shpolyansky
Manager, Global Branding and Channel Marketing
Abbott
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.
3:30p.m. — 4:00p.m.
CT
Connect Break
4:15p.m. — 5:00p.m.
CT
Plenary - Advancing Health Equity: Role of Technology in the Future of Healthcare
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
Paige Bingham leads the Boston Scientific Close the Gap initiative to address health disparities and collaborate with healthcare providers to advance equity in their communities. In 2022, Close
the Gap identified over 121,000 women and people of color missing equitable specialty care and equipped 70 hospitals to take action. With a passion for innovative transformation, Paige has held leadership positions at Allina Health, Medtronic, General Mills, and Deloitte. She has also served on the boards of YWCA Minneapolis, Twin Cities RISE and WomenHeart. Paige holds an MBA from The Wharton School at the University of Pennsylvania and a BA fromClaremont McKenna College.
Sessions
Plenary - Advancing Health Equity: Role of Technology in the Future of Healthcare
Tuesday, 30 April
16:15 CT
Paige Bingham
Director, Close the Gap
Boston Scientific
Austin L Chiang, MD MPH
Chief Medical Officer, Medtronic Endoscopy
Medtronic
Dr. Chiang is the first Chief Medical Officer for the Endoscopy business of Medtronic, the global leader in health technology. He is also currently an Assistant Professor of Medicine at an academic teaching hospital in Philadelphia, PA, and serves as the Director of the Endoscopic Weight Loss Program. He completed his undergraduate studies at Duke University before earning his MD at Columbia University. He stayed for Internal Medicine residency at New York Presbyterian Hospital and completed his GI and bariatric endoscopy fellowships at Brigham and Women's Hospital. He obtained his MPH from the Harvard TH Chan School of Public Health before completing an advanced endoscopy fellowship at Jefferson.
Passionate about empowering patients with accurate medical information online, he is one of the most influential voices in the field of gastroenterology across multiple social media platforms. Dr. Chiang has conducted extensive research in social media and is champion of physician presence on social. He was formerly the Chief Medical Social Media Officer of Jefferson Health and Founding President of the Association for Healthcare Social Media (AHSM), the first 501(c)(3) professional society for health professional social media use. He has worked closely with all major national GI societies on social media efforts and was 2018’s Healio Gastroenterology Disruptive Innovator of the Year, The Philadelphia Inquirer’s 2019 Influencers of Healthcare Rookie of the Year, among 2019 Medscape Top 20 Social Media Physicians, and a 2021 GLAAD Media Award Nominee. He spoke at South by Southwest 2021, and his role in social media has been featured by The New York Times, CNBC, and BBC News. He sits on the inaugural YouTube Health Advisory Board and in 2022, joined the White House Healthcare Leaders in Social Media Roundtable.
Sessions
Plenary - Advancing Health Equity: Role of Technology in the Future of Healthcare
Tuesday, 30 April
16:15 CT
Austin L Chiang, MD MPH
Chief Medical Officer, Medtronic Endoscopy
Medtronic
6:00p.m. — 10:30p.m.
CT
Evening Event - Stubb's BBQ
Join us for a fun evening at Stubb's BBQ including cocktail hour, dinner, networking, and live entertainment. Stubbs is just two blocks from the Hilton Austin.
https://www.stubbsaustin.com/
Wednesday, May 1
8:00a.m. — 9:00a.m.
CT
Networking Breakfast
9:00a.m. — 9:45a.m.
CT
Vault Clinical Operations Product Roadmap
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.
Navigating Regulatory Landscapes: QA/RA Global Harmonization Strategies
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 Bio-Rad 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
Davina R. Marano has dedicated her legal career to improving public health. As Senior International Counsel in FDA’s Center for Devices and Radiological Health (CDRH), she shapes the landscape of medical device laws and policies globally. Before joining international affairs, Davina served as senior advisor to CDRH’s Chief of Staff and as regulatory counsel in FDA’s Center for Drug Evaluation and Research (CDER). Davina holds a law degree, a master’s degree in experimental psychology, and a certificate in business excellence.
Sessions
Navigating Regulatory Landscapes: QA/RA Global Harmonization Strategies
Wednesday, 1 May
9:00 CT
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
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
Navigating Regulatory Landscapes: QA/RA Global Harmonization Strategies
Wednesday, 1 May
9:00 CT
Peter Shearstone
Vice President, Global Quality & Regulatory Affairs
Thermo Fisher Scientific
Elizabeth Platt
Vice President, Regulatory & Clinical Affairs
Bio-Rad Laboratories
Elizabeth is a clinical laboratory scientist with more than 30 years of experience at Bio-Rad Laboratories in global regulatory submissions and clinical study management. As vice president of global regulatory & clinical affairs, Elizabeth leads a global team of professionals based in 16 countries that support a large portfolio of IVD products. Bio-Rad is currently undergoing eQMS transformation to implement Vault QualityDocs, QMS, and eTMF clinical operations modules.
Sessions
Aligning Quality Transformation with Business Priorities
Tuesday, 30 April
11:00 CT
Navigating Regulatory Landscapes: QA/RA Global Harmonization Strategies
Wednesday, 1 May
9:00 CT
Elizabeth Platt
Vice President, Regulatory & Clinical Affairs
Bio-Rad Laboratories
Veeva Medical Suite: Art of the Possible
Introduction to Veeva Medical Suite including understanding of Vault Medical, how the applications work together connecting software and data to scale medical affairs.
Transforming Claims, Evidence, and Substantiation
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
Christina has more than 25 years of experience overseeing clinical, health economics and outcomes research, and preclinical research conducted by industry, contract research organizations, academia, and non-governmental organizations. She is also an agile process expert in clinical, medical, quality and audit functions. Christina has led clinical, data management and biostatistics, clinical compliance and audit teams ensuring a flexible model to achieve agility while ensuring compliance. By partnering with international regulatory authorities, she's helped develop and implement training initiatives in multiple areas.
Sessions
Building an Effective Promotional Claims Management Approach
Tuesday, 30 April
9:45 CT
Transforming Claims, Evidence, and Substantiation
Wednesday, 1 May
9:00 CT
Christina Villar
Head Clinical Affairs
Philips
Vault MedComms and Vault MedInquiry Product Roadmap
Hear the latest and upcoming features for both Vault MedComms and Vault MedInquiry
10:00a.m. — 10:45a.m.
CT
Transforming Clinical and the Importance of a Unified Global Approach
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
Disha is an IT leader with over 15 years of experience driving transformation across clinical digital platforms & data to deliver evidence driven insights and outcomes. She has expertise across clinical processes and systems encompassing key areas – Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), eTMF, Safety and Reporting.
Sessions
Transforming Clinical and the Importance of a Unified Global Approach
Wednesday, 1 May
10:00 CT
Disha Mittal
Associate Director, Clinical Technology Strategy
Boston Scientific
Niharika Brahmbhatt
Sr. Director, Global Clinical Technology Strategy & Enablement
Boston Scientific
Sessions
Transforming Clinical and the Importance of a Unified Global Approach
Wednesday, 1 May
10:00 CT
Niharika Brahmbhatt
Sr. Director, Global Clinical Technology Strategy & Enablement
Boston Scientific
Tracking the Evolution of Electronic Templates: eSTAR and Future Pathways
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
Mr. Syed is involved in eSTAR development and revisions including PMA content additions. He has also served as a lead reviewer in both CDRH and CBER, reviewing medical devices such as Oxygen Concentrators, Infusion Pumps, and Class III blood screening Analyzers. Prior to joining the FDA, Mr. Syed was a Systems Engineer at a Biomedical startup developing software/hardware solutions for medication compliance.
Sessions
Tracking the Evolution of Electronic Templates: eSTAR and Future Pathways
Wednesday, 1 May
10:00 CT
Sajjad Syed
Software Engineer
FDA
The Importance of Learning Management in Quality Transformation
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
Sr. Quality Manager
Corza Medical (Pearsalls)
Yvonne has been quality manager at Corza Medical for nine years and has worked in a number of industries over the last 40 years including automotive, defense and aerospace. Yvonne's team at Corza implemented Veeva Vault Quality Docs and Training approximately six months ago and is in the process of implementing additional modules.
Sessions
The Importance of Learning Management in Quality Transformation
Wednesday, 1 May
10:00 CT
Yvonne Yeo
Sr. Quality Manager
Corza Medical (Pearsalls)
Jonathan Fessler
Manager, Global Quality Training
Glaukos
With 23 years of service in the US Navy, Jonathan served as an instructor, course curriculum manager, master training specialist, and director of training. Transitioning to Glaukos, he is now manager of global quality training, overseeing GMP training requirements across all sites. His career reflects a deep commitment to excellence in training and development, ensuring adherence to the highest standards in every endeavor.
Sessions
The Importance of Learning Management in Quality Transformation
Wednesday, 1 May
10:00 CT
Jonathan Fessler
Manager, Global Quality Training
Glaukos
Accelerating Content Creation with DAM: How to Make It Happen
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
Amy Jo has more than 20 years of experience in the Medical Device field. She manages the global process and users for Vault PromoMats, which includes digital campaigns, as well as project and digital asset management (DAM) for internal Creative Services. She earned her degree in Information Systems while working for Zimmer Biomet.
Sessions
Accelerating Content Creation with DAM: How to Make It Happen
Wednesday, 1 May
10:00 CT
Amy Jo Brown
Marketing Operations Specialist
Zimmer Biomet
Vault CRM for MedTech: Field Medical Deep Dive
Vault Platform Technical 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.
10:45a.m. — 11:15a.m.
CT
Connect Break
11:20a.m. — 12:00p.m.
CT
Medtech Development: Leader Perspectives on Accelerating Innovation
Medtech leaders discuss how to optimize the development process for faster innovation, including strategies to bridge the gap between patient needs, regulatory compliance, and the critical infrastructure required across the organization to operate efficiently and scale for digitization.
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
Medtech Development: Leader Perspectives on Accelerating Innovation
Wednesday, 1 May
11:20 CT
Paul Swift
Head of RA/CA, Americas
Carl Zeiss Meditec
Joanna Mitri, MD, MS
Chief Medical Officer
Sequel Med Tech
Sessions
Medtech Development: Leader Perspectives on Accelerating Innovation
Wednesday, 1 May
11:20 CT
Joanna Mitri, MD, MS
Chief Medical Officer
Sequel Med Tech
12:00p.m. — 1:00p.m.
CT
Networking Lunch
1:00p.m. — 3:00p.m.
CT
Vault Clinical Data Community Meeting
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.
Vault Clinical Operations Community Meeting
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.
Vault RIM Community Meeting
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.
Vault Quality Community Meeting
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.
Vault Commercial Content Community Meeting
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.
