Powerful Community, Fresh Ideas

Torkil trained as a pharmacist in Denmark, where he gained his MSC from the Royal Danish School of Pharmacy. He is now part of the faculty at the University of Copenhagen. Torkil has over 25 years of experience in regulatory, spanning clinical regulatory strategy, EU and international regulatory affairs, labelling, regulatory operations and information management. Currently, he is head of global regulatory delivery and excellence. His team is responsible for delivering all global submissions and overseeing regulatory processes, systems, data management and digital transformation across GRA.

Elizabeth is senior director and head of global pharmacovigilance and reporting operations at UCB, where she brings more than 20 years of progressive PV experience spanning global safety data management, PV operations, quality, literature surveillance, clinical research and oncology nursing. Most recently, she led UCB’s enterprise-wide ICSR transition to Veeva Safety. She is accountable for the end-to-end oversight of individual ICSR delivery and vendor management across UCB’s full product portfolio ensuring compliance with global regulations and driving large-scale PV modernization and centralization initiatives. Elizabeth’s professional interests are centered on automation and PV benchmarking to manage emerging PV challenges and ecosystem evolution.

Jonas is a global digital leader transforming how pharmaceutical organizations operate across R&D and patient safety through technology, data, and AI. He recently spearheaded one of the pharmaceutical industry’s first large-scale, big bang implementations of Veeva Vault Safety, modernizing global pharmacovigilance overnight and laying the foundation for AI-powered safety operations. Combining strategic vision with execution excellence, he builds high-performing teams and drives change at enterprise scale to accelerate innovation and improve outcomes for patients worldwide.

Marc is responsible for the growth and execution of the Veeva Regulatory product line. Prior to joining Veeva, he served as client partner and RIM consulting lead at Kinapse, now Syneos Health. Additionally, he spent 14 years in Accenture’s Pharmaceutical R&D practice where he led the regulatory advisory, business development, and alliance efforts.

Peter Gassner is the visionary behind Veeva where he pioneered the industry cloud category when he founded the company in 2007 with the belief that vertical cloud software would be the next wave of cloud innovation. With more than 30 years experience at leading technology companies, Peter has been at the forefront of every major transition in enterprise software, from the mainframe at IBM Silicon Valley Lab, to client-server at PeopleSoft, the cloud at Salesforce, and industry cloud software and AI at Veeva. He was a key visionary force behind three of the industry’s most successful enterprise application platforms: Veeva Vault, the Salesforce Platform, and PeopleTools.

Melody is the director of product management at Accumulus Technologies, where she leads product strategy and delivery for cloud-based solutions that enable more connected and efficient collaboration across the life sciences regulatory ecosystem. She brings more than a decade of experience across life sciences technology, healthcare technology, product management, UX, and enterprise SaaS, translating complex user and business needs into practical, scalable products. Melody’s work spans product strategy, platform delivery, cross-functional execution, and the responsible application of AI to modernize regulatory workflows. Notably, she led the product strategy and delivery of technology supporting one of the largest regulatory reliance reviews to date. She explores how emerging capabilities can complement sponsors’ existing technology ecosystems, simplify global regulatory collaboration, and help organizations identify and scale the regulatory activities where digital collaboration can deliver the greatest value.

Wolfgang is the executive director of technology at Amgen, serving as the organization’s Veeva platform and enterprise lead. Bringing more than three decades of experience in digital transformation, regulatory and quality systems, and large-scale business modernization, he drives enterprise strategy and the enterprise-wide adoption of Veeva capabilities.

Petra is a director of clinical applications at Amgen, bringing more than 20 years of experience across EDC operations, product management, programming, and clinical data management. She has contributed to several enterprise technology implementations and actively advocates for innovative technologies and approaches to advance clinical trial execution.

Tine brings nearly 20 years of experience in development operations, beginning her career in site management and project management before transitioning into line management and vendor oversight. Over the past five years, she has focused on innovation and process improvement, leading major transformation initiatives at Amgen.

Randhir is a technology delivery and governance leader at Amgen, leading platform and vendor governance for the enterprise Veeva Platform. With 14 years of experience, he specializes in enterprise operating models, technology platform and product operations, digital transformation, and vendor management. He holds a B.E., an MBA from IIT Kanpur, and an M.S. in Business Analytics from USF.

Pete has been a practicing pediatrician in Utah since 1998 and brings 27 years of experience conducting clinical research. He was previously the co-owner of an independent clinical research company until its acquisition by AMR Clinical in 2021, and subsequently sold his medical practice in 2022.

Dawn began her career in pharmacovigilance in 2010 with United BioSource, where she spent 13 years developing extensive expertise across a broad range of drug safety functions. In January 2023, she joined Amylyx Pharmaceuticals, bringing with her a strong foundation in pharmacovigilance gained from both contract research organization (CRO) and pharmaceutical industry perspectives. Her experience includes, but not limited to, supporting audits and regulatory inspections, leading database migration initiatives, and providing effective vendor oversight and management.

Joe has over 15 years of experience in pharmacovigilance, focusing on patient safety from clinical trials to commercial launch. As the head of safety and PV at Amylyx Pharmaceuticals, his team successfully transitioned from a vendor-hosted Argus database to Veeva Vault Safety in 2023. They are currently working on assessing AI efficiencies, Workbench, and Vault connectors.

Sadia has over 13 years of experience in medical writing, with a primary focus on regulatory documentation and global submissions. She plays a key role in cross-functional collaboration, supporting IND, NDA, and MAA submissions across clinical, medical, CMC, and regulatory teams. Her professional interests include optimizing regulatory processes, advancing submission technologies, and enhancing document quality and consistency. She has worked with Veeva RIM for four years, successfully leading the implementation of Submissions and Submissions Archive and currently advancing publishing capabilities.

Debbie is a senior director of regulatory systems at AstraZeneca, bringing over 40 years of drug development experience to her role. Throughout her extensive career primarily within regulatory, she has focused on leveraging systems and modern technology to automate workflows and establish industry best practices. Ultimately, her work centers on streamlining regulatory operations to deliver life-saving medicines to patients faster.

Robert is a seasoned clinical development specialist with extensive experience across biometry, data management, data standards, and clinical systems. Since the 1990s, he has defined global procedural and system-based ways of working, helping transform Bayer’s clinical development digital environment into an integrated platform landscape. In his leadership roles, Robert has driven key initiatives, including global standardization, Bayer’s TransCelerate membership, and the deployment of a global operations landscape on Veeva Vault. Today, he focuses on advancing clinical digital capabilities, reducing participant and site burden, and exploring responsible AI use within a GxP environment. Robert holds a degree in computer science from Technische Universität Berlin and leverages a systems analyst’s perspective to bridge business and IT needs.

Emma has over 20 years of experience in the pharmaceutical industry. She started as a monitor and has held various positions in clinical development operations. During that time, Emma worked on multiple systems and process implementation projects. She works with a team of business solution managers responsible for implementing, maintaining, and supporting key systems utilized by clinical development operations, including Veeva Clinical and Veeva Study Training. In 2021, Emma received the Veeva Hero Award for her work to eliminate system siloes at Bayer.

Swathi is a strategic leader with extensive experience guiding global clinical data management and programming teams. She is recognized for defining and executing transformational strategies that unify cross-functional capabilities, strengthen operational excellence, and harness emerging industry trends to drive innovation and business impact.

Christopher is the associate director of global regulatory solutions enablement at BeOne Medicines. With over a decade of expertise in global regulatory operations, he specializes in optimizing eCTD publishing, as well as configuring and enabling Veeva RIM Vaults. Christopher is passionate about bridging the gap between complex health authority requirements and efficient technology to accelerate patient access to life-saving therapies. He recently served as a key member in the historic Accumulus pilot with Chile’s Public Health Institute (ISP). This trailblazing initiative pioneered Chile’s first-ever fully digital, cloud-based review of a novel oncology dossier, establishing a new model for faster global patient access.

Sharon is a drug safety leader with expertise in pharmacovigilance operational excellence and the implementation of technology systems that support global patient safety processes. She has led complex, cross-functional initiatives using technology-enabled solutions to ensure organizational compliance and readiness with global regulations. Her focus centers on harmonizing global pharmacovigilance activities into streamlined, integrated processes that leverage technology, data, and stakeholder collaboration.

Shane is a quality leader with more than 20 years of experience in the pharmaceutical industry, specializing in global quality systems, compliance, operational excellence, and quality integration across multi-site manufacturing networks. At Bora Pharmaceuticals, he leads efforts to harmonize quality processes, strengthen compliance, and advance global quality management practices.

Throughout his career, Shane has supported global quality system standardization, inspection readiness, enterprise system implementation, regulatory commitments, and continuous improvement initiatives across multiple pharmaceutical manufacturing organizations.

Angie is the executive director of global project management and strategic solutions at Celerion, bringing nearly two decades of early clinical research experience across clinical operations, project management, and strategic technology enablement. She has played a key role in advancing Celerion’s digital transformation by implementing enterprise solutions that improve project visibility, automate workflows, and strengthen operational execution. As system owner for Celerion’s Veeva environment, she provides strategic oversight of the platform while driving technology, governance, and process improvements to simplify clinical operations. She is dedicated to building scalable solutions and high-performing teams that elevate the client experience and support world-class project delivery.

Dylan began his career in clinical research before transitioning into healthcare consulting and life sciences technology, including over four years at Veeva within site solutions. He currently serves as a Veeva Vault administrator at Celerion, where he leads the adoption strategy across ClinOps, SiteVault, and Quality Vault. Additionally, Dylan directs Celerion’s internal Veeva administration team to support end users and optimize system execution.

Megan is the director of clinical data management – EDC at Celerion, bringing over 10 years of experience across clinical data management, EDC database development, and software testing. She leads teams overseeing clinical data management and EDC development while guiding enterprise technology initiatives focused on system evaluation, implementation, adoption, and process transformation. Her work centers on clinical data technology, automation, process optimization, and building scalable solutions that enhance data quality and operational efficiency.

Staci is the vice president of global scientific clinical operations at Celerion, where she leads global clinical operations supporting complex early-phase clinical research. Her focus areas include operational excellence, digital transformation, participant recruitment, and using technology to improve study execution and team effectiveness. Throughout her career, she has driven scalable processes and global collaboration to enhance experiences for sponsors, study teams, and trial participants. She is particularly focused on leveraging platforms like Veeva to enable consistency, transparency, and efficiency across clinical operations.

Dan serves as chief editor of Clinical Leader, where he oversees editorial content focused on clinical trial operations. He also hosts the Clinical Leader Live webinar series, covering critical industry topics such as AI integration, regulatory shifts, and patient recruitment diversity. Previously, he spent 14 years as editorial director for Life Science Leader magazine. His background also includes work as a technology writer and ten years in hospital business development and communications.

Michael has more than 20 years of experience in the regulatory affairs space, spanning regulatory publishing, systems, project management, strategy, and writing in addition to clinical trials transparency. He has worked for small, medium, and large biopharmaceutical companies including Baxter, Allergan, Medimmune, Acadia, and most recently Cytokinetics where he oversees regulatory operations, medical writing, and clinical trials transparency. He holds a bachelor’s degree from Susquehanna University and a master’s degree in regulatory science from the University of Southern California.

Shailesh has over 12 years of experience in biologics and small molecules across major pharma and biotech. He is recognized for leading high‑performing QC organizations, strengthening regulatory compliance, and managing global CDMO networks. His achievements include successful regulatory inspections, implementation of global data‑integrity frameworks, and major operational‑efficiency improvements. He currently focuses on scaling commercial analytical QC capabilities to support long‑term business growth and continuous improvement.

Charles has spent 28 years leading biopharmaceutical stability programs, quality laboratories, and enterprise quality systems. Drawing on his mature operational background at companies like Pfizer and Bristol Myers Squibb, he’s helping scaling virtual biopharma balance strict compliance with risk-based decision-making. Charles believes that modernizing digital capabilities elevates the entire quality system while positioning both internal teams and external partners as a strategic advantage.

Todd has spent the last 25 years at Eli Lilly, beginning his career supporting custom software solutions for authoring and publishing. In 2006 he was instrumental in the vendor selection and implementation of Lilly’s first eCTD solution, and he has remained active in the regulatory space ever since. Today he serves as product owner for RIM Publishing, supporting the business through process design and optimization, configuration updates, and new release adoption. Over the past year and a half, his primary focus has been advancing the use of the global content plan within RIM.

Ashik is a regulatory affairs professional serving as a manager within the GRA regulatory delivery and excellence organization, where he supports regulatory operations and submission delivery activities. His professional interests include regulatory information management, electronic regulatory submissions, health authority correspondence processes, and the application of standards to improve regulatory data quality and efficiency. He had over eight years of experience in regulatory biopharma field and is passionate about bringing new innovative ideas to the regulatory space.

Nancy is a business director in Clinical Result Systems at Lilly, with a 28-year tenure spanning both pre-clinical and clinical roles across the organization. She has developed deep expertise in toxicology pathology, biospecimen banking, and clinical data management within Veeva CDMS. In her current role, Nancy focuses on Veeva CDB, DQS, and integrations to optimize data workflows and system connectivity across the clinical trial ecosystem.

Nihar is a strategic healthcare leader with over 20 years of experience in the R&D space, focused especially on directing regulatory operations and global product launches across pharmaceutical, vaccine, and medical device sectors. His professional areas of interest center on driving enterprise-wide data transformation, establishing end-to-end dossier management frameworks, and converting strategies into tactical plans and executing. A pioneer in operational excellence, Nihar’s achievements to date include securing critical regulatory approvals ahead of schedule, contributing to successful product launches, and implementing enterprise-wide asset management infrastructure. He currently serves as senior director of regulatory affairs at Emergent BioSolutions, overseeing regulatory operations, intelligence, project and change management.

Praveen is an IT leader with over 25 years experience working for large (Merck, Baxter and Gilead) as well as small/medium (Ascendis and Exelixis) pharma and biotech companies. Currently at Exelixis as an IT leader supporting drug development, supply chain and quality business functions.

Robert is a senior quality metrics and data analyst at Fortrea, where he leads initiatives focused on quality analytics, regulatory compliance, audit readiness, and continuous process improvement across the Vault Quality environment. He has a strong professional interest in quality management systems, risk-based quality management, data-driven decision making, and the application of emerging technologies such as AI to improve operational effectiveness. Throughout his career, he has played a key role in advancing enterprise quality programs, overseeing audit and CAPA metrics, supporting system governance initiatives, and driving cross-functional process enhancements that strengthen quality and compliance outcomes. He is recognized for translating complex data and quality insights into actionable strategies and executive-level communications that support organizational decision making and continuous improvement.

Jennifer is a strategic quality leader with over 20 years of experience leading global teams and enterprise-wide quality initiatives. Proven record of modernizing QMS programs, aligning global business process ownership, and delivering large-scale technology transformations. Recognized for building cross-functional alignment across quality, regulatory affairs, manufacturing, global supply chain, IT, and R&D to deliver scalable, compliant, and business-focused quality solutions.

Michael has over 25 years of experience in healthcare, medical diagnostics and devices, and pharmaceutical industries where he has held senior quality and compliance leadership positions. Michael has led three successful enterprise-level quality system transformations in the last 15 years at major biotechnology companies.

Kathy is a drug safety operations executive with broad international pharmaceutical experience across clinical research, medical affairs, and pharmacovigilance. She specializes in systems thinking and the design and execution of high-quality global pharmacovigilance systems and processes. Throughout her career, Kathy has led drug safety teams and provided strategic oversight for complex global and regional business partner collaborations.

Éric is a senior biometrics leader with extensive experience across clinical data management, biostatistics, and clinical trial operations. Throughout his career, he has led high-performing teams, driven process improvements, and supported the successful delivery of global clinical research programs. Éric is passionate about advancing clinical technology, risk-based quality management, and operational excellence to optimize trial execution.

Vanessa is an assistant director of GxP quality systems with a focus in vendor management at Ionis Pharmaceuticals and a leader in GMP quality and compliance. She brings more than 15 years of experience across GxP quality systems, GMP vendor management oversight, and inspection management. She has a strong track record of applying risk-based approaches to vendor qualification, performance oversight, and inspection readiness. Her professional interests include GMP quality systems governance, vendor oversight, and advancing practical, scalable quality processes that strengthen compliance, operational execution, and business impact.

JT is an assistant director in development IT at Ionis Pharmaceuticals and a leader in quality and regulatory business systems. Over the course of his career, he has led complex GxP system deployments and served as system owner for critical platforms across biotech and pharmaceutical organizations, delivering compliant, scalable solutions that support operational excellence. His professional interests include Veeva platforms, pharmaceutical quality and regulatory operations, and the use of AI and automation to strengthen processes, improve information access, and drive meaningful business impact.

Sabrina is the head of clinical data management and data sciences innovation, bringing more than 21 years of experience across clinical research, data management, and strategic transformation. Over her career, she has built deep expertise in risk-based approaches, operational improvement, and large-scale transformation initiatives that bridge strategy and execution. In her current role, Sabrina drives the evolution of data management within the broader clinical data ecosystem, focusing on technology-enabled and AI-powered approaches to optimize data flow, strengthen governance, and increase operational efficiency throughout the clinical trial lifecycle.

Tara is the manager of clinical trial learning and training at Johnson & Johnson, where she helps advance training strategies and learning solutions to support study teams and operational excellence. Her extensive background as a clinical research professional spans research nursing, institutional review board (IRB) oversight, clinical trial management, and learning development. Tara brings a strong understanding of study conduct, regulatory expectations, and cross-functional collaboration to high-quality clinical trial execution, reflecting a career-long commitment to patient-centered research, compliance, and continuous improvement.

Stephen is a clinical research professional with 10 years of experience spanning quality and clinical functions. In his current role at Kailera Therapeutics, he focuses on implementing and leveraging clinical technology to help the clinical operations team manage trials more efficiently and compliantly. Stephen thrives in start-up environments, where he enjoys wearing multiple hats and gaining hands-on exposure to all facets of clinical research.

Dee is senior director of regulatory operations at Kailera Therapeutics, where she leads global regulatory submission operations and oversees regulatory technology strategy. With 25 years of experience and RAC certification, she has built and scaled regulatory operations functions at Synageva, Cerevel, and Kailera, supporting submissions across the U.S., Europe, Canada, and Australia. Dee has led multiple Veeva RIM implementations, including launches at Cerevel and Kailera, and is passionate about leveraging technology and process innovation to drive regulatory excellence and accelerate patient access to therapies.

Sandi is the director of eTMF and inspection readiness at Keenova, where she leads the eTMF team responsible for the oversight and governance of the Veeva Vault Clinical platform and procedures. She brings 25 years of pharmaceutical industry experience, specializing entirely within the document management space. Throughout her career, Sandi has driven operational efficiencies, process improvements, and inspection-readiness initiatives across organizations ranging from small biotechs to global enterprises. She focuses on navigating the evolution of the Trial Master File (TMF) to help organizations maximize resource and technology utilization while maintaining strict quality, procedural, and regulatory compliance.

Kailash is an accomplished quality and validation professional with over 16 years of experience across the pharmaceutical, biologics, and medical device industries. His professional interests include quality systems, computer system validation, equipment and facility qualification, data integrity, and global quality system implementation. Throughout his career, he has successfully led major quality and validation initiatives, supported global system implementations, and served as a subject matter expert for audits and regulatory inspections. He has also demonstrated strong leadership in building cross-functional teams, driving global harmonization, and implementing continuous improvement initiatives. He holds a Master’s degree in Pharmaceutical Manufacturing Engineering along with a Bachelor of Pharmacy.

Joe has worked in regulatory operations for more than 30 years. His experience spans planning, authoring, publishing and registration management. He drives the implementation of Veeva RIM within Merck while fostering strong collaboration.

Jody is the senior application business owner at NMDP, administering Veeva QMS and Veeva Safety. She has a passion for analyzing and presenting data to a variety of audiences and is eager to leverage new features and enhancements, including Process Monitor.

Jared Lantzy is the executive director of global regulatory affairs operations at Novavax, where he leads strategy, technology, and process transformation within the regulatory operations function. He focuses on the human side of operational change, helping teams navigate process and organizational transformation. A certified project management professional (PMP), Jared builds scalable, technology-enabled operating models for regulatory teams in small- to medium-sized biopharma organizations.

Evelyn is a clinical research professional with more than 20 years of experience leading global Phase I–III clinical trials across a broad range of therapeutic areas, including infectious diseases, immunology, pain management, dermatology, and nephrology. Her core expertise centers on clinical data management, operational excellence, process optimization, and leveraging technology to improve trial quality and efficiency. Throughout her career, Evelyn has successfully established and led a Data Management department, building high-performing teams and implementing scalable processes to support complex global development programs. She is recognized for her collaborative leadership, strategic mindset, and commitment to delivering high-quality data that drives successful clinical outcomes.

Catherine is a biopharmaceutical leader with over 30 years of experience across both large and small organizations. Prior to joining Oruka, she led the Biometrics department at Cara Therapeutics, where she built a high-performing, cross-functional team that supported the clinical development and FDA approval of IV KORSUVA™ for chronic itch in end-stage renal disease patients. Throughout her career, Catherine has overseen biometrics deliverables across numerous development programs, driving regulatory approvals across anti-infective, chronic pain, and dermatological indications.

Jennifer is a seasoned Clinical Data Management professional with more than 25 years of industry experience. She began her career in document management, supporting the processing and organization of paper Case Report Forms (CRFs) for data entry, and steadily advanced through roles of increasing responsibility. Throughout her career, she has gained extensive experience working within both small and large pharmaceutical organizations, developing a broad and well-rounded understanding of clinical data management operations.
Jennifer is a Certified Clinical Data Manager (CCDM) and has been recognized for her leadership potential through selection for an internal leadership development program. Her combination of technical expertise, industry knowledge, and leadership experience has enabled her to make significant contributions across a wide range of clinical development initiatives.

Christie is a seasoned clinical research professional with a 37-year career across the industry, including 28 years at Parexel. Her foundation in clinical research was built as a research site director and clinical research associate. For the past 15 years, she has served as a solution enablement lead, implementing systems, advancing business solutions, and driving innovation for the benefit of sponsors, study sites, and patients.

Dr. Emma A. Meagher is a professor of medicine and pharmacology at the Perelman School of Medicine (PSOM) at the University of Pennsylvania. In her dual roles as senior vice dean for clinical and translational research and senior associate vice provost for human research, she sets the overarching strategy and oversees the university’s clinical and translational research portfolio. Additionally, as vice president for clinical research within the University of Pennsylvania Health System (UPHS), Dr. Meagher leads the integration and alignment of clinical practice and research across seven hospitals and an extensive network of ambulatory care practices.

Gisele is a global life sciences executive with more than 25 years of experience leading quality, manufacturing, and digital transformation initiatives across the pharmaceutical industry. She has led large-scale enterprise programs, including global QC and quality systems implementations across multinational manufacturing networks, driving innovation, data integrity, and operational excellence. Her professional interests include advancing digital quality, AI-enabled transformation, and developing future leaders through coaching and mentorship. She is passionate about improving patient outcomes by building connected, data-driven organizations that deliver meaningful and sustainable change.

Amha is the regulatory operations user engagement lead at Regeneron Pharmaceuticals. With over a decade of experience in change management, he has navigated major regulatory operations evolutions across paper, electronic, and cloud-based systems. His work focuses on helping teams adapt to continuous industry shifts, driven by the perspective that proactive preparation is key to successfully managing change.

Amy is a senior regulatory submission manager with over eight years of experience specializing in global regulatory operations. As the product owner for the publishing capability during Roche’s Veeva RIM implementation, she led the adoption and integration of RIM’s publishing features. Amy focuses on streamlining submission workflows and optimizing capability performance to drive regulatory submission efficiency across the region.

Erin is the director of site engagement and innovation strategy at Sanofi. She previously served as the US innovation lead for Sanofi’s clinical study unit.

Jamison brings two decades of experience to the biopharmaceutical industry, with a career spanning data management, on-site monitoring, study management, and organizational leadership. This diverse background provides him with a comprehensive perspective on the clinical trial lifecycle and enables him to effectively bridge operational, quality, and technology functions. In his current role, Jamison collaborates across teams to lead strategic initiatives focused on optimizing clinical systems, streamlining processes, and driving the successful execution of clinical trials.

Kelsey is a regulatory information management leader with expertise in regulatory operations, digital transformation, and Veeva RIM. As Director of Regulatory Information Management at Takeda, she leads initiatives that improve data quality, streamline processes, and support global regulatory operations. Her interests include regulatory data strategy, automation, and user enablement. Throughout her career, she has successfully led complex system implementations and global initiatives that enhance regulatory efficiency and compliance.

Ryan is a seasoned regulatory operations leader with more than 20 years of experience in the pharmaceutical industry. At Teva, he is responsible for advancing global regulatory operations strategy, capabilities, and execution across the organization. Throughout his career, Ryan has worked within small, mid-sized, and large pharmaceutical companies, overseeing the compilation and submission of hundreds of regulatory applications worldwide. He is passionate about developing regulatory operations professionals and designing efficient, scalable processes that enable organizations to successfully navigate an evolving global
regulatory landscape.

Matthew is a seasoned biopharmaceutical industry professional with more than 20 years of experience in quality, validation, and compliance. He currently serves as principal of The Sentinel Consulting Group. Throughout his career, he has held a variety of leadership positions, including validation global process owner, head of computer compliance, and global validation director, process validation at GSK.

Mr. McMenamin holds a Bachelor of Science in Chemical Engineering from North Carolina State University.

Brook brings 10 years of experience leading GxP training initiatives including implementing a learning management system and learning experience platform. She is passionate about guiding learning ecosystem evolution to balance compliance, inspection readiness and learner experience.

Arash, MD, PhD, is a professor of medicine and bioengineering at UCLA, where he serves as senior associate dean for clinical research at the David Geffen School of Medicine and chief medical officer for clinical research for UCLA Health. He also serves as a director of the UCLA Clinical and Translational Science Institute and associate director of the Jonsson Comprehensive Cancer Center. In these roles, he leads the Office of Clinical Research, which provides infrastructure for clinical research across the UCLA campus. His personal research focuses on the intersection of medicine and technology, with a particular emphasis on assessing older and frail patient populations.

Michelle has worked in a myriad of industries, including pharmaceuticals, IT, pulp and paper, and food with companies such as GSK, Novartis, Veloxis, Global Knowledge and ConAgra. Through her winding career, the people are always her motivation: the employees, the leaders, the patients so training has always been at the forefront of her mind. Having achieved her PMP, multiple leadership, facilitation, and operational excellence certifications throughout her 30+ year career, she is well-equipped to help people and companies develop strategies and achieve their goals through passion, dedication, and diligence.

Ilona brings 20 years of regulatory operations experience spanning large pharma and early-stage biotech, where she has led teams, transformed organizations, and built outsourcing models. She has been involved in more than 30 Veeva RIM implementations, helping companies adopt and scale their systems to work more efficiently. Known for her strategic, problem-solving mindset and her passion for developing people, she is a vision-driven leader who pairs long-term thinking with practical execution. She co-founded Votum Consulting to change the way traditional RegOps vendors work — with the goal of making the space genuinely transformational, particularly as AI reshapes what’s possible.

Anthony provides strategic and operational support to life sciences companies implementing and managing regulatory systems, processes, and submissions. He has over 15 years of experience in the field, working with global regulatory teams and cross-functional teams. Previously, Anthony held roles at Genentech and Myovant Sciences, where he contributed to the development and execution of regulatory information management (RIM) systems, eCTD publishing and submissions, and SOP and process creation. He managed a team of regulatory operations professionals and was a business owner of the Veeva RIM platform. Anthony is passionate about applying innovative and efficient solutions to complex regulatory challenges and ensuring compliance and quality standards.

Eric is the president of Zubee Consulting Inc., where he advises life sciences organizations on quality control laboratory operations, digital transformation, and regulated technology implementations. His professional interests include laboratory informatics, data integrity, computer system validation, and the practical use of emerging technologies to improve compliance, efficiency, and decision-making. Throughout his career, he has led and supported complex laboratory modernization initiatives involving LIMS, LES, SDMS, environmental monitoring, and quality management systems. His achievements include serving in senior quality control leadership roles, delivering cross-functional transformation programs, and building a consulting practice that translates scientific, business, and regulatory requirements into sustainable solutions.

Peter has dedicated over a decade to the GxP training sector and currently leads a team of strategic GxP training advisors at Veeva supporting training solutions. Peter’s work also focuses on global regulatory intelligence and product innovation for the LearnGxP library.

Crystal leads Veeva’s government strategy initiatives to modernize data submission standards and platforms. She engages with regulators and customers to shape the future of the submissions ecosystem. As an expert in FDA electronic submissions and health data standards, Crystal contributes to Veeva’s product direction and works with the public policy team to position Veeva as a voice in the industry.

Brad leads product management for Veeva’s Agentic Authoring solution, Falcon Writer. He was a founding member of the Veeva Safety team, then went on to lead product for Submissions, Submissions Archive, and Publishing. He is a co-inventor on a U.S. patent for AI-based document interpretation.

As the Director of Product Management for the Vault Platform, Mark is responsible for enriching the developer experience for Veeva Vault. He works with customers, partners, services, and world-class product team to ensure all Vault Developers have a seamless and productive experience.

Nicole has over 10 years of experience in the pharmaceutical industry. She has held every position you can think of in a training organization. She loves dogs and hates the smell of fresh cut grass.

Stephen leads product management for Veeva QualityDocs, Station Manager, and Training products within the Veeva Quality Cloud. Alongside his team of product managers, he drives the product roadmap and execution of high-impact features designed to solve complex industry compliance and operational challenges. Stephen brings 15 years of healthcare technology expertise to his role developing electronic health record (EHR) systems prior to joining Veeva about five years ago.

Ryan is a 15 year Veeva veteran, having spent the first 11 years on the professional services team and later bringing his technical knowledge and customer experience with him to the sales organization. Ryan completed well over 100 implementations across all R&D and Quality Cloud applications both for Pharma and MedTech customers.

Rylan leads R&D business consulting globally- a team of over 200 subject matter expert consultants from various backgrounds. His expertise lies in clinical operations and clinical data. Before Veeva, Rylan was a leader at the Boston Consulting Group and an officer in the US Navy.

Erin has worked as a product manager in highly regulated spaces, including government tech, K12 education, and life sciences, for the past 10 years. Her product mantra is “Can the product be simpler? Then make it simpler.”

Anthony Corso leads Veeva’s global policy strategy focused on modernizing clinical research. He works with global regulators, legislative bodies, and industry coalitions to advance practical approaches that reduce operational burden, improve patient access to clinical trials, and support a more efficient research ecosystem. Prior to Veeva, Anthony led healthcare IT and regulatory initiatives at Epic Systems, including a collaboration with the U.S. Department of Veterans Affairs. Anthony is a U.S. Army Special Operations veteran who remains an active advocate for the veteran community.

As Vice President of Product Management for Veeva Safety, Eldar leads the product teams for Safety, SafetyDocs, Safety Workbench, Safety Signal, and Vault AI for Safety focusing on transforming the pharmacovigilance landscape through innovation and developing world-class applications. A seasoned product leader with over 20 years of experience, Eldar has a proven track record of delivering high-impact technology solutions and driving measurable value for enterprise customers globally. Before joining Veeva, his career was focused on enterprise software, where he tackled complex challenges using advanced technologies across diverse industries.

Paola leads product strategy for QualityDocs and Station Manager, leveraging over 25 years of diverse Quality and IT experience. Her deep expertise covers enterprise document management, training, QMS, lab, and pharmacovigilance systems. Paola’s unique career journey through industry, consulting, and software provides a comprehensive understanding of the challenges and opportunities in this space. She is passionate about empowering the industry to achieve greater quality compliance and efficiency through evolving document management systems with refined best practices and innovation.

Mike is the strategy lead for Veeva Batch Release, specializing in innovative solutions that automate and streamline batch release processes. He collaborates closely with customers to transform traditional paper-based systems into efficient digital workflows, significantly enhancing operational visibility and ensuring robust market shipment decisions. Mike joined Veeva with over 15 years of extensive experience in the life sciences quality domain.

As a product expert for Vault Platform, Mike focuses on providing education on platform functionality through Veeva Connect Communities and ensuring customers have the best possible information to adopt and leverage Vault Platform functionality. His focus areas within Vault Platform are docs (including document viewer, renditions and core doc functionality), Vault Mobile, expected document lists, reports and dashboards, and security.

Kelly brings two decades of experience to her role where she is responsible for Registrations and structured data reporting like XEVMPD, IDMP and UPD.

Alice Foltyn is a senior solution consultant at Veeva Systems specializing in clinical data management. Drawing on her eight-year background across professional services and solution consulting, she serves as a core subject matter expert in study design, RBQM, and automated adverse event intake.

Tom joined Veeva in 2011 as one of the original Vault solution consultants and is now responsible for supporting the Veeva clinical suite of applications. Tom has been working in the SaaS multi-tenant content management space for over 25 years in a variety of pre and post sales roles, and is always excited to demonstrate Veeva’s product offerings to new and existing customers.

Nick leads the Site Solutions business at Veeva, as well as serving as the executive sponsor for public policy. Nick previously was a senior leader at Epic, after a career in the US Marines and finance.

Drew Garty has spent over 25 years in pharmaceutical technology, earning multiple patents and the 2015 “Clinical Innovator of the Year” award for his work in risk-based approaches. He joined Veeva in 2016 to build Veeva’s clinical data management systems from the ground up. Now serving as Chief Technology Officer for Clinical Data, Drew works with customers and industry partners to drive the vision for Veeva’s product family.

Graham Gelwicks leads product management for Vault Platform analytics, workflows, objects, common components and the Vault AI tab. Drawing on a diverse background in enterprise software, analytics, and strategy consulting, Graham is passionate about driving continuous innovation across the Vault ecosystem. Graham holds undergraduate degrees in business and economics from UC Berkeley, and a masters in computer science from University of Illinois, Urbana-Champaign.

Joby leads the product management team for Veeva LIMS. Joby has over ten years of experience designing and delivering enterprise quality and training solutions for the life sciences market.

Nader drives market growth and product direction for Veeva RIM across North America. He has extensive experience leading R&D implementations and business process changes for global biopharmas. Today, he aligns sales operations with product development to help life science organizations optimize their regulatory workflows.

Ruben Gottardi is a senior solution consultant at Veeva Systems with years of experience architecting and implementing mission-critical enterprise cloud solutions for global life sciences organizations. He specializes in digital transformation and validation management, focusing on translating complex GxP and FDA regulatory requirements into scalable platform strategies that maximize quality and compliance.

Lisa Thompson-Greene is a principal product manager on the Veeva QMS team, where she owns Complaints, Quality Language Translations, and Record Check applications. Over the past three releases she has been working on the next generation of the Complaints application. Prior to joining the QMS team, Lisa owned the eForms product. Lisa is a UC Berkeley graduate with a B.A. and an MBA, who began her career in management consulting before moving into product management at Model N, where she experienced the company’s journey through IPO. Lisa has spent much of her career at the intersection of product management and life sciences. She is passionate about building software that helps quality teams work smarter and more efficiently.

Andy Han is responsible for Vault Platform and Veeva AI products. His team is focused on delivering integrated application AI agents and a robust platform for rapid development of Agentic AI Applications. Andy has over 25 years of enterprise software experience and has held product positions at NextLabs, Siebel Systems, and Accenture.

Jason is a product manager passionate about helping customers meet their educational goals through technology. He focuses on helping customers while defining and executing the product roadmap for Veeva Training. Prior to coming to Veeva, he worked for 18 years in the education industry as a developer, administrator, and product manager of learning management systems.

Jim has spent his career working on document management solutions for the life sciences industry with the last 14 years focused on eTMF applications. Jim is driven by finding ways to make processes more efficient and to improve user experiences to ultimately make managing TMF documentation easier and to increase the quality of the TMF. Additionally, Jim is interested in how new technologies and insights into data can be leveraged to innovate and drive the industry forward.

Manaphan joined Veeva in October 2016 and has held product leadership roles in commercial content and Asia. He is currently the Senior Director of Product Management for Veeva QMS. Manaphan is passionate about making products that customers love to use and building software solutions that simplify the complex. Before joining Veeva, he spent more than 15 years supporting, implementing, and building sales and marketing automation software across multiple verticals and geographies. Manaphan received an Master of Science in Computer Science from Boston University and a Bachelor of Business Association in Management Information Systems from the University of Texas at Austin.

Crystal supports Veeva’s largest customers in North America. She has 20 years’ experience with biopharmas and CROs. She is passionate about building processes that keep people at the heart of digital transformation, ensuring technology is an indispensable, fully utilized asset.

Eric has over 25 years of pharmaceutical and medical device industry experience. Most of that time has been focused on data management and technology adoption. Eric leads Veeva’s team of solution consultants for clinical data applications.

Ancy Johnson is a seasoned consultant with 11 years of experience in the life sciences industry. Her quality experience led her to focus on the safety and pharmacovigilance space.

Ryan joined Veeva in September 2019 and is responsible for the design, development, and leads the delivery of Vault Payments capabilities and other Vault CTMS components. He is passionate about clinical technology and the opportunities to streamline the process of getting medical advancements delivered to patients quicker. Prior to Veeva, he spent over 10 years leading clinical and financial software development activities. Additionally, he has supported the full SDLC for numerous clinical technology projects as a project manager and worked to develop clinical diagnostic testing capabilities as a research scientist. He received a Bachelor of Science in Molecular Biology and Philosophy at Beloit College.

Nick Klatt is a senior solutions consultant on the clinical data team with a background spanning pharmaceuticals, CRO, and vendors. He works closely with the larger clinical team to help realize platform value for customers while also serving as a source of AI expertise within the clinical data domain. He is interested in effective and responsible technology advancements, ensuring value for customers and the patients they treat.

Justin is a laboratory informatics professional, with a career dedicated to advancing digital transformation within life sciences. With over 20 years of experience, he has worked alongside global pharmaceutical and biotech leaders to navigate the complexities of modernizing laboratory operations through leading technology solutions.

Ray leads product for Veeva’s EDC and DQS Clinical Data applications. He has been in this role with Veeva for over nine years and has been in enterprise software for almost three decades.

Cindy defines the strategic roadmap for assistive agents and drives the delivery of Vault AI features for RIM. Drawing from her implementation and RIM product expertise, Cindy partners with biopharmas to transform their regulatory operations through practical, user-centric AI solutions.

Fernando leads Veeva’s global Quality Business Consulting team. His team of dedicated life sciences quality consultants support all business aspects of an agentic quality transformation, including value case, operating model and business process design, and change management. Before joining Veeva, Fernando was a partner at the Boston Consulting Group focusing on life sciences quality.

Radha has a strong interest in optimizing solutions to drive accuracy and efficiency for users. She has worked on impactful features, including the RIM-PromoMats Document Transfer Integration, and Auto-Append STF features. Ask her about the upcoming Pseudo-Replace feature for Japan eCTD 4.0!

Alex Margolis has over 15 years of experience across the life sciences and healthcare sectors. His primary focus areas include quality and QMS transformations, process optimization, and driving change for both scaling biotechs and multinational pharmaceutical companies. Throughout his career, he has supported Quality leaders with navigating complex regulatory environments, modernizing quality systems, and embedding operational excellence across global operations.

Alison’s 20-year career includes regulatory submissions leadership, consulting, and process optimization. She’s spent six years on Veeva’s RIM team, now leading strategy for the Veeva Labeling application.

Jim Markley has over a decade of experience managing TMFs spanning across sites, CROs, and consulting. Jim is interested in how customers are applying risk-based approaches to their TMF operations.

Eric has been a developer support engineer at Veeva for over four years, where he carries a passion to make integrating and developing with Vault a smooth and enjoyable endeavor. He carries a deep expertise of Vault developer features and has contributed to various open-source tools produced by the developer experience team.

Lucy is a clinical data solution consultant who partners with sales to demonstrate the value of Veeva’s connected platform. She leverages nearly six years of clinical data management experience across two CROs to understand complex customer objectives and propose tailored solutions that improve workflows and operational processes.

Rich leads the product management team responsible for Veeva RIM. Throughout his career, he has been instrumental in developing software solutions that help life sciences organizations accelerate time-to-market while ensuring compliance.

Jason has the great opportunity to do many different things at Veeva. For the last four years, he has led the Clinical Operationss strategy group and our 400+ person Clinical Operationss business within Veeva. Over that period, the team doubled the Clinical Operations revenue and launched three new products.

Kaitlyn Moore leads the product development of Veeva Disclosures, drawing on her extensive experience in healthcare and clinical trials software to create innovative user experiences. She has spent 15 years leading software development teams.

Kayla is a senior product manager at Veeva, focused on supporting CTMS. Kayla has worked in regulated industries for 10+ years, supporting medical devices and pharmaceutical development.

Angela focuses on features and capabilities that span Veeva RIM, such as active dossier, health authority interactions, and email to RIM. Prior to this, she managed the RIM-Clinical Operations connection and the RIM-PromoMats connection.

Carl Ning leads product strategy for Veeva QMS application. With over 25 years of experience delivering transformative solutions in life sciences, consumer products, discrete manufacturing, and financial services industries, Carl has dedicated over 20 of those years to quality management/quality systems. With experience in over 200 quality and regulatory system design and implementation projects, he is dedicated to driving innovation in quality solutions. His work focuses on helping organizations meet regulatory requirements, addressing business challenges, and enhancing efficiency and value for both customers and the industry – with his primary objective to support the life sciences sector in achieving optimal product quality and ensuring patient safety.

Sarah O’Hora is an AVP in business consulting at Veeva Systems, where she leads Clinical AI initiatives that help life sciences organizations adopt AI in practical, scalable ways. With more than 20 years of experience in clinical operations, including the past 12 years at Veeva, she has helped life sciences organizations transform clinical operations through process optimization, operating model redesign, and organizational change. Her current focus is helping organizations realize the full potential of AI by combining technology with new ways of working.

Graham O’Keeffe is a leader in GxP compliance and digital learning for the life sciences industry. Graham has been a vocal advocate for moving beyond “check-the-box” compliance. As the General Manager of Veeva LearnGxP, Graham leads the strategic direction for one of the industry’s most comprehensive libraries of accredited GxP training content.

Pratyusha leads strategy for Veeva Falcon and Agentic Authoring. She is accountable for long-term product direction, market growth, and long-term customer success with Veeva’s agentic labor offerings for Regulatory. She has more than 20 years’ experience in product strategy, enterprise customer engagements, and engineering in the life sciences and healthcare industries.

Kristie brings over 10 years of diverse life sciences experience, spanning hands-on laboratory research, quality engineering, and enterprise solution consulting. In her role at Veeva, she specializes in aligning complex platform capabilities with the rigorous compliance and operational standards of global pharmaceutical enterprises. Kristie is at the forefront of laboratory innovation, leading cross-functional efforts to build out advanced laboratory procedures and integrate configurable AI agent capabilities.

Chris Pontisso is the director of product management for Veeva Validation Management. Chris has worked in the Enterprise SaaS software space for nearly two decades, focusing on validation over the last five years.

Alexis is a senior solution consultant for eCOA at Veeva Systems, where she partners with life sciences and medical technology organizations to modernize clinical trial execution through patient-centric technology. She specializes in aligning business strategy with digital transformation initiatives, helping sponsors and CROs evaluate solutions, streamline operations, and improve patient experiences. Drawing on expertise across commercial strategy, product management, and clinical technology, Alexis serves as a trusted advisor to organizations navigating complex technology decisions across the clinical development lifecycle.

With over 15 years in life sciences, Nina has been a catalyst for change in digital validation for the past eight years. As a senior strategy lead at Veeva, she is a leading advocate for data-centric methodologies and risk-based approaches, championing digital transformation by driving standardization and unification to modernize validation practices.

Taylor manages Veeva RIM Submissions, where he owns content planning, dossier assembly, and submission setup. Based in Ottawa, he also leads applied AI research at Durham College, where he has worked with industry partners since 2018.

Luke offers 18 years of experience in the biopharma and global health sectors. His experience has spanned the biopharma value chain, with a focus on organizational transformation. He is passionate about helping customers realize their AI vision.

Erita started her career conducting research at a pharmaceutical company. She first joined Veeva as a professional services consultant and implemented the Clinical Application Suite for global enterprise customers. Today, Erita is a senior product Mmanager on the Vault Clinical Operations team and is responsible for designing and delivering capabilities for Site Connect.

Lena has more than 25 years’ experience working with life science customers leading software and business process initiatives. She holds an MD in Pediatrics from the Medical School of Belarusian State University. She is passionate about helping the life sciences industry advance through technological innovation to improve patient outcomes.

Brian leads product management for Veeva Batch Release. In this role, he is responsible for building a solution that will help pharmaceutical companies qualify their products with improved time to market and increased confidence. Prior to Veeva, Brian founded Propel Software, a PLM and QMS solutions provider and held product management roles at Apeel Sciences, Equilar, and Oracle.

Caríosa Switzer defines the product roadmap for Veeva Registrations. Her background is rooted in pharmaceutical regulatory affairs and data management. Prior to product management, she managed R&D Services teams focusing on RIM implementations.

John specializes in connecting Veeva RIM to other Veeva applications including Quality, Safety, Medical, and PromoMats. His current focus areas are enhanced change management between QMS and Regulatory, ad promo submissions between RIM and PromoMats, the new RIM to Medical Connection, and connecting product data across the Veeva ecosystem. John has 25 years’ experience in IT implementations, systems integration, and development.

Nick brings over 20 years of experience to his role as Product Manager for Veeva Labeling. Prior to Labeling, Nick has led the Registrations product management team and owned MedTech features within RIM.

Nathan leads the Global Development Excellence (DevEx) practice within Veeva’s R&D Business Consulting team. He helps customers maximize the value of their Veeva Development Cloud investments through strategic roadmapping, connected operating models, and robust enterprise and AI governance. Nathan specializes in guiding AI pilots from concept to scale, standardizing cross-domain data, and accelerating platform ROI.

Joseph drives Veeva’s North America enterprise regulatory strategy. He specializes in aligning customer vision with product roadmaps and navigating the unique, regulatory challenges faced by mid-to-large organizations. Throughout his career, Joseph has successfully bridged sales, product management, services, and consulting to deliver high-value solutions to biopharmas.

Cooper VanLare currently leads product development for the Site Solutions team at Veeva, where he has spent the last five years building site-facing clinical software. Prior to Veeva, he spent eight years developing and deploying research site technology with a focus on CTMS, eSource, and eConsent.

Jordan has deep expertise across all areas of Veeva RIM. He works within the Veeva Falcon team to bring agentic workflows to Regulatory customers.

Jon Young is a North America strategy lead for Veeva Clinical Data with extensive experience in the data management realm with biotechs as well as CROs. He works with client teams to develop strategies for modernizing data management with Veeva. Jon uses his data management background to help study teams address their challenges with new solutions. He connects sales, services, and product teams to ensure Veeva is delivering exemplary service to customers. Before Veeva, Jon spent 12 years at Parexel, where he started as a project and account manager for a small EDC partner. From there, he moved into a data management lead/principal data management role focusing on data cleaning and managing data through to submission. Most recently, as a group manager in the biotech division, Jon was passionate about finding ways to streamline tasks without reducing quality.