Powerful Community, Fresh Ideas

Astrid Scherer is the VP, Global Head of Clinical Data & Performance Excellence (CD&PE) at Bayer AG, leading the transformation of clinical development through innovative concepts, processes, and technologies. With extensive experience across strategy, pharmacovigilance, medical affairs, and commercial operations, she has spearheaded numerous cross-functional initiatives, including PV transformation and the implementation of the Medical Customer Powerhouse in collaboration with Veeva. Astrid is based in Basel, Switzerland, and holds degrees in Pharmacy and Translation/Interpretation from the Universities of Bonn and Cologne.

Jeroen is a pharmacovigilance expert with nearly 20 years of experience in different roles across the PV space. He is a leader on MSD’s business system management and innovation team, acting as business owner for the Veeva Safety platform following implementation in early 2025.

Ibrahim Kamstrup-Akkaoui is a senior leader in clinical data management at Novo Nordisk and has 20 years of experience working with data and clinical studies. Ibrahim has also led multiple projects that evolve the way data management is conducted at Novo Nordisk and the broader industry. He is currently leading the DataNow Program to renew the digital infrastructure for clinical studies, with end users and patients as the focus.

Javier has over 25 years of experience in the pharmaceutical industry, having held positions in quality, regulatory affairs (CMC/development), and regulatory operations. He is currently the head of regulatory operations at Teva, where he is responsible for implementing all regulatory systems and processes, focusing on bringing global digital solutions and innovations, specifically in the AI and Automation space, to improve working processes and regulatory outcomes. He is a subject matter expert for xEVMPD, IDMP, and eCTD and is involved in several ICH, EMA, and industry association working groups.

Hugo leads clinical strategy in Europe at Veeva. Hugo has over 20 years experience working in technology and consulting, focused on helping clinical and R&D organizations innovate and improve performance.

As Sr. Director of Development Cloud Strategy, Jared drives the vision and execution to deliver connected and streamlined processes across clinical, regulatory, safety and quality businesses. With over 15 years of experience in life sciences and healthcare technology, including his prior work at Epic in the electronic medical records space, Jared brings deep expertise in leveraging technology to improve operational efficiency and patient outcomes.

John Lawrie is Vice President of Veeva Safety Strategy and is responsible for growing Veeva’s safety market adoption while ensuring the success of its customers. Before joining Veeva, John led the consulting practice at Octagon Research Solutions (now Accenture), which specialized in helping customers develop CDISC-based data and regulatory submission capabilities to achieve global regulatory compliance while maximizing operating efficiencies. He has 25 years of experience in the pharmaceutical industry and extensive experience with implementing globally-deployed systems.

As the VP of Product Management for the Vault Platform at Veeva Systems, Larry builds the industry cloud for life sciences to deliver innovative and scalable solutions that empower our customers to streamline their processes, enhance their compliance, and improve their outcomes.

Paul is a technologist and business development professional whose experience spans 40 years – 8 years as a software engineer and 32 dedicated in life sciences. He currently leads Veeva’s regulatory strategy activities in Europe, helping customers maximize the value of Veeva RIM. He also has experience in business development, product management, product architecture, software development, and professional services at DxC, CSC and FCG.

Dominique joined Accumulus Synergy in 2022 as the senior vice president of regulatory innovation. Before joining Accumulus, Dominique worked in various leadership roles in regulatory operations for the past 25 years, most recently leading Amgen’s global regulatory operations function. In his role at Accumulus, Dominique engages with global health authorities and industry partners to drive regulatory innovation leveraging cloud technologies. Dominique has also been a Board member of the IRISS Forum since 2021. Dominique holds a Pharm D and a Master’s in International Regulatory Affairs from the University of Paris.

Joyce brings 25 years of industry expertise spanning multiple disciplines and a diverse range of therapeutic areas. For the past 18 years, Joyce has focused on patient engagement, she is passionate about widening participation in clinical research and developing and deploying technology approaches to engage with both sites and patients. In her current position as global head of patient engagement at Allucent, she is part of the clinical trial organizations leadership team. She is responsible for leading, managing, and overseeing patient recruitment activities and Allucent’s eCOA and DCT offering.

Regulatory operations publishing, data system, and processes expert with 25 years of experience encompassing medicinal, biologic, devices, food supplements, and cosmetics. Isabelle is a subject matter expert in eCTD publishing, managing a performing publishing team and RIM suite with the implementation of Veeva RIM within first GSK (Haleon) and now in Alvotech.

Lovisa is a senior project lead at Alvotech, specializing in organizational and operational excellence. With over six years of experience in the biotechnology industry, Lovisa has successfully led high-impact initiatives, including the Veeva LIMS implementation. She prioritizes ensuring compliance and efficiency. Passionate about fostering a culture of continuous improvement, Lovisa plays a key role in optimizing processes and supporting Alvotech’s mission to expand global access to high-quality biologics.

Hanna is a senior manager within Quality System & Compliance at Ascendis Pharma A/S in Copenhagen. She is responsible for driving improvements and developing quality processes. Hanna has more than 28 years of experience in the pharmaceutical industry, working with QMS processes, including quality risk management. She holds a chemical engineering degree from the Technical University of Denmark.

Balaji is a global delivery leader with 20+ years of experience in IT for Pharmaceutical R&D. He specializes in regulatory and quality functions and has led major transformations. Currently, he leads the regulatory and quality IT platform in AstraZeneca. He is passionate about building high-performance teams and setting up operating models, processes, and ways of working.

Jenny has 20+ years of experience working with regulatory information management systems in Arizona. When AstraZeneca implemented Veeva RIM, Jenny led the data governance workstream, defining data standards and principles. In 2022, she moved to a new role as the AZ Veeva RIM product manager to focus on setting up and leading the continuous improvement of AZ Veeva RIM. She works to establish priorities and develop the AZ Veeva RIM roadmap.

Head of Global Clinical Solutions Services, Marta oversees teams focused on eTMF, CTMS, SLD, eCOA and RTSM. She is a team oriented leader with almost 14 years of experience in clinical trials, leading cross-functional and multicultural teams, and working across global and local organizations.

Debbie is a senior director at AstraZeneca. She has worked in pharma for nearly 40 years across multiple domains and implemented content management solutions, most recently Veeva RIM.

Andrea Barz is an experienced leader with a distinguished background in quality assurance and management within the pharmaceutical industry. Currently serving as the lead digital quality at Bayer AG, she plays a pivotal role in advancing digital quality initiatives, focusing on the integration of innovative technologies to enhance quality assurance processes.

With over a decade of experience in various quality-related roles, Andrea has demonstrated exceptional leadership in managing cross-functional teams and driving transformative initiatives. Her responsibilities include overseeing digital transformation projects that streamline quality management systems and improve operational efficiency. Andrea’s commitment to excellence and strategic guidance has significantly contributed to the success of numerous high-impact projects. She holds a degree in Biopharmaceutical Technologies and is dedicated to fostering collaboration and continuous improvement within her teams, leveraging her analytical skills to navigate challenges and drive effective solutions in the dynamic landscape of the life sciences industry.

Dr. Aniela Heidebrecht is an accomplished IT professional with a strong track record in leading transformative initiatives within the healthcare and life sciences. Currently serving as the IT program lead for IQMS at Bayer AG, Aniela is at the forefront of a pivotal shift towards integrated quality management solutions. With a background as an IT product manager and a Ph.D. in Molecular Biosciences, she brings a unique blend of scientific expertise and strategic IT leadership. Aniela has been instrumental in driving digital cloud-native products, such as an Advanced Analytics Platform for the clinical environment, and has demonstrated exceptional leadership in fostering collaboration and driving strategic initiatives across the organization.

Olaf Ehses is a seasoned professional with over 25 years of experience in the life sciences, specializing in quality assurance for medical devices and pharmaceuticals. Currently serving as the business program lead in Corporate and Pharmaceutical Quality at Bayer AG, Olaf has demonstrated his expertise in various quality assurance roles throughout his career.

His leadership has spearheaded numerous projects, from new product development to technology transfer and IT system implementation. Olaf is a dedicated team player who strongly emphasizes collaboration, leveraging his analytical skills to drive effective team problem-solving and decision-making.

Sheila is a US American living in Germany. Her primary focus in her job as Master Data Manager at Bayer Pharmaceuticals is on cross-functional and global master and reference data management. Additionally, she is co-leading ISO teams of experts on the systematic review of the IDMP standard ISO11615 and guidance on IDMP Ontology. Sheila co-initiated the IDMP Ontology together with multiple pharma colleagues and service providers under the umbrella of the Pistoia Alliance.

Elisabeth is Senior Director Global Systems Quality at BioNTech SE being responsible for the implementation of the GxP One QMS and Supplier & Material Qualification amongst other things. During her diverse career journey, Elisabeth held different roles in Quality Systems, Supply Chain, Operations, Quality Operations and Operational Excellence (Novartis Vaccines, GSK Vaccines). The roles often went alongside change, transformation and organisational change becoming an important area of interest as well as her drive for continuous improvement.

Carina is a motivational leader with 20+ years of in-depth clinical development experience through all stages and multiple therapeutic areas. Her business acumen, international leadership, and organizational development expertise complement her system lifecycle competencies. She focuses on establishing empowered, high-performing teams with a strong capability-based operating model. She has successfully delivered huge organizational and digital transformations while driving a holistic digital and data strategy for ClinDev execution.

Marco is the head of global regulatory operations and RA digital innovation and system owner for Vault RIM at Boehringer Ingelheim.

In her current role as Principal Process Capability Manager, she is part of the “DCT Enablement” capability within Patient & Site Engagement. In this role she is focusing on MyVeeva eCOA capabilities to as well as leading the site advisory panel, a group of site staff that act as experts and provide feedback and input on any capability update that might have a site impact.

After 12 years in consulting, Martin joined Boehringer Ingelheim in 2013. He headed several IT areas, including data integration, migration, and content management. In 2022, Martin took over the program management of Boehringer Ingelheim’s One Medicine Platform. As part of this project, he led the implementation of Veeva applications across multiple areas, including clinical data management, clinical operations, quality, and regulatory affairs.

Oliver has worked in the pharmaceutical industry for over 20 years, focusing on process management and digitalization. He enables R&D employees to excel in their work using cutting-edge technology and methods.

Martin leads the clinical data collection capability area at Boehringer Ingelheim and has over 20 years of experience in biometrics and data science across academia and pharma. His team oversees the systems and processes for clinical data acquisition in clinical trials. Martin is passionate about organizational development and agile methodologies, Martin focuses on fostering user-centricity and end-to-end thinking in clinical development.

Vada is vice president, global head of regulatory intelligence & policy for Boehringer Ingelheim. He is a former FDA senior advisor for Regulatory Science with global regulatory policy & intelligence expertise in applying international standards to regulatory science and policy initiatives. His continued collaboration with national and international stakeholders promotes convergence in policy and strategy in the assessment of medicinal products worldwide. He received his degrees from Johns Hopkins University, the University of Southern California, and the University of Maryland.

Annalisa is the head of global regulatory affairs digital and publishing at Chiesi. With over 17 years of experience in the pharmaceutical industry, she has led numerous strategic projects, such as implementing Veeva RIMS and IDMP. She also plays a crucial role in advancing digital and data-driven initiatives across the R&D value chain. Her areas of interest include cutting-edge regulatory solutions and enhancing cross-functional collaboration to drive impactful changes and operational excellence.

Johanna is a pharmacist by training and has a PhD in clinical pharmacology. She has extensive experience in pharmacovigilance/drug safety, working in academia at the Uppsala Monitoring Centre, industry through a CRO company, and several global MAHs.

Kasia is an accomplished IT Product Manager in Roche’s regulatory science and portfolio delivery product line. She specializes in leveraging technology and digitalization to drive business value. Within Roche’s RIM program, she played a pivotal role in delivering active dossiers and ensuring seamless systems integrations.

Matthew currently serves as the Senior Product Owner and is responsible for shaping and executing the technology roadmap in harmony with GSK’s global clinical operations objectives, with a specific focus on study start up. His concentration lies in consistently refining user experiences and business outcomes for solutions and systems catering to study start up.

Thomas has 20 years of experience in the pharmaceutical industry, specializing in Document Management Systems. Since 2013, he has been the Product Owner of GSK eTMF, delivering Veeva eTMF implementation project and eTMF migrations. Currently, he serves as the Tech Lead for the GSK Site Connect Implementation project.

Krisztián brings extensive experience in structural biochemistry, regulatory assessment, and strategic leadership. As a former assessor, he contributed to various EMA committees and working groups, playing a key role in shaping regulatory frameworks. He has been instrumental in modernizing regulatory operations and leveraging digital transformation to enhance efficiency and compliance. His expertise spans data management, operations, and content production, driving innovation across global subsidiaries. Through strategic foresight and innovation, Krisztián continues to shape the future of pharmaceutical regulation, ensuring excellence in a rapidly evolving landscape.

Sofie Morville Schrøder is a seasoned leader in IT systems and quality management, with a strong background in Veeva Vault and GxP-regulated environments. She currently leads maintenance and innovation of Veeva Quality at Genmab, driving strategic system development, process optimization, and cross-functional collaboration. With a passion for bridging business and technology, Sofie has successfully led key projects and supported global digital transformation in the life sciences industry.

Andrzej has a robust career spanning various roles in IT and system engineering. He has demonstrated expertise in managing and enhancing business-critical applications such as Veeva Vault and Documentum. He has a keen interest in improving processes, ensuring system integrity, driving continuous improvement, and consistently contributing to the design and architecture of IT solutions. Andrzej joined the safety team at Haleon over a year ago.

Karol is an experienced system technology manager with a robust IT infrastructure, technology management, and product engineering background. Currently driving architectural consistency and maturity across quality and laboratory products and services at Haleon while managing organizational vulnerabilities and ensuring alignment with Haleon Digital & Tech quality standards. Proficient in Veeva platform, architecture, Azure, ITIL, service management, release processes, FinOps, CloudHealth, and databases. Outside of professional pursuits, Karol is a dedicated athletics enthusiast (marathoner), physiotherapy advocate, and automotive aficionado.

Mateusz is a senior system engineer with extensive experience in designing and building IT solutions for R&D applications. He has a strong background in agile methodologies, Microsoft Azure, and DevOps practices. Mateusz has achieved significant milestones, including building CI/CD pipelines using GitHub Actions and Azure DevOps. He is also skilled in Veeva systems and holds the Vault Platform Associate Administrator certification from Veeva Training Services.

Mateusz Michalak is a seasoned Veeva product and platform architect with extensive experience in the pharmaceutical and healthcare industries. He specializes in designing and implementing innovative Veeva solutions to enhance operational efficiency and compliance. Mateusz has a strong background in IT architecture and project management and is passionate about leveraging technology to drive business transformation. His notable achievements include leading successful Veeva implementations across multiple regions and contributing to developing industry best practices. Mateusz is dedicated to continuous learning and participates in industry conferences and forums.

With over 16 years of experience in IT, Prasidda serves as a senior system engineer specializing in R&D clinical. She is dedicated to spearheading the development, implementation, and support of cutting-edge IT solutions for clinical applications. Her role encompasses the comprehensive management of cloud infrastructure supporting products, intricate systems architecture, and connectivity design. Prasidda has successfully led the implementation of several high-impact projects, including the deployment of a robust cloud infrastructure that significantly enhanced system performance and reliability. She also played a key role in designing and executing a comprehensive disaster recovery plan, ensuring business continuity and data integrity.

A clinical research professional, covering 39 years of working in the area of clinical research, both CRO and Pharma, from data management, coding, clinical trial design, trial management and oversight from phase I to Phase IV. Extensive experience in setting up clinical operational department structure, personnel, and processes. Multiple territories and indications covered over the many years.

Marie-Line joined Ipsen in 2018, specializing in eTMF management. She was key in implementing a quality control and oversight process, collaborating with multiple CROs to enhance trial documentation compliance and efficiency. She’s interested in clinical trial management, quality assurance, and regulatory compliance, focusing on optimizing processes and ensuring high standards in clinical research.

Since 2018, Morgane has developed a strong expertise in clinical systems, focusing on quality control (QC) and oversight processes in eTMF. With a keen eye for detail and a commitment to maintaining high standards, Morgane has successfully ensured the accuracy and integrity of clinical trial documentation through rigorous QC practices. Her work has contributed to streamlined operations, compliance, and the overall success of clinical trials in eTMF management and process optimization.

A strategic and results-driven transformation leader with a strong background in corporate quality, project/program management, digitalization and adult education. Experienced in leading global business transformation initiatives and optimizing electronic quality management systems (eQMS) solutions. Passionate about driving change, fostering collaboration, and leveraging data-driven insights to enhance operational excellence.

Results-driven and forward-thinking leader with over 20 years of experience in the chemical and biopharma industries, specializing in continuous improvement strategies, eQMS, innovation, and new technology on a corporate level. Proven track record in business process ownership, project management, and organizational leadership. Active contributor to industry advisory boards and mentorship programs.

Anand is an enterprise data leader with over 20 years of experience designing and executing strategic and large-scale data initiatives. He has experience in life science, investment banking, insurance, and telecom. He is a certified chief digital officer, data professional, and black belt.

Denise is a regulatory professional with over 11 years of experience and a background in legal. She began her career at Roche, where she specialized in regulatory records and data management, serving as the product owner for the Documentum regulatory archive. She later joined Novartis as a CMC senior data and digital manager, where she partners across functions to drive digital innovation, implement governance standards, and shape the digital roadmap for regulatory affairs. She is the data workstream lead for Vault RIM document management implementation, leading key initiatives for regulatory data governance, and the deployment of a master data management system. With a strong focus on enterprise data, she works to enhance data quality, streamline regulatory processes, and establish governance frameworks.

Carsten has over 20 years of experience in clinical data management, spanning programming, project management, and leadership. Passionate about process optimization, he is dedicated to simplifying workflows and driving efficiency in clinical research.

Srinivasan is a global leader in clinical data management and operations. He has built a multi-disciplinary data management function with a strategic focus on future success. As the head of data standards and integration at Novo Nordisk, he drives efforts to establish an efficient infrastructure for high-quality data.

Kamal is a regulatory operations team lead at OM Pharma with 17 years of experience in regulatory affairs and regulatory operations. He is in charge of electronic submissions, xevmpd/idmp, and regulatory systems management activities.

Andreas Särnberger has over 10 years of experience in the life sciences, in roles ranging from QA to validation. Andreas has a strong passion for IT compliance. At Recipharm, he has successfully merged the industry’s appetite for new technologies with the strict compliance requirements, enabling Recipharm’s journey into the cloud.

Laura Prada Alonso is a seasoned professional with a global perspective, specializing in strategic transformation projects within the digital quality domain. She has extensive experience managing multicultural teams and navigating complex organizational structures and has successfully led initiatives that drive operational excellence. Recently, Laura spearheaded the Veeva QualityDocs and Training implementation across Recipharm, enhancing and harmonizing processes across 17 sites. Laura is driven by her passion for creating meaningful change within organizations, ensuring every project has a solid business case, and its performance is continuously measured to guarantee alignment with strategic goals. Her ability to lead cross-functional teams in diverse, international environments is a key strength.

Luca Manfro is passionate about driving digital innovation in life sciences, with a strong focus on AI and data-driven technologies. With a career bridging IT and R&D, he brings both technical expertise and a strategic perspective. Currently, as group R&D digital solutions manager at Recordati, Luca leads the implementation and evolution of critical clinical systems (EDC, eTMF, CTMS, RTSM) and coordinates the AI & Innovation Lab to accelerate digital transformation within R&D.

In her 15 years of experience in quality assurance, Birte Müller has gained extensive knowledge of biotech products’ entire production life cycle. She has a strong interest in digitalization and has been involved in implementing various systems, such as Veeva QMS and a Laboratory Information Management System (LIMS). Most recently, in addition to her GMP compliance team leader role, she led the implementation of Veeva QualityDocs and Veeva Training.

Lynsey has nine years of experience in regulatory operations. She recently led the successful implementation of active dossier at Roche. Her focus lies in driving accessible, accurate, and reliable data to enhance cross-functional collaboration and promote operational excellence.

Solenn is a transformation catalyst in clinical operations, supporting strategic change and optimization. With a background in statistics and extensive experience in clinical trials, she transitioned into roles focused on enabling transformation. She supports business functions in defining their vision, executing strategy, and fostering adoption through strong stakeholder engagement. Currently, Solenn is contributing to the implementation of the Veeva Vault Clinical Operations platform, supporting its successful integration and adoption.

Geoff is currently CTO and co-founder of Scitara. He is an experienced executive with over twenty five years in the life science industry. He has deep scientific, technical and product development knowledge gained from leading R&D teams to produce innovative technologies and products. He has broad industry domain knowledge and market understanding in the major life science disciplines including biomedical research, large pharma and biotech, emerging therapeutics and synthetic biology. Geoff is creative and social at identifying business opportunities with an infectious passion that helps move the needle and implement.

Phoebe’s passion for system and process usability drives her work at Syneos Health consultancy, where she leads clinical data implementations for clients. After nearly a decade in clinical operations at a Top 20 Pharma, Phoebe leverages her dual perspective as a former client and current consultant to challenge SMEs and decision makers to think both innovatively and practically. Excelling as a ‘translator’ between business aspirations and system functionality, Phoebe brings a unique pragmatism to tackle even the most daunting implementation challenges.

Ediwin has led digital technology at UCB Biopharma for three years. His previous experience includes roles in FMCG (P&G and HEINEKEN) and other pharma companies (Teva and Sanofi). An experienced data and technology leader with a track record of delivering results across diverse companies and cultures. He creates business-aligned digital technology strategies. Having worked and lived in seven countries, Ediwin is a Dutch national based in Brussels, Belgium. In his free time, he enjoys sailing his Nacra F18 catamaran on the North Sea.

Ed Taylor has over 30 years of experience in investigational, clinical, and commercial manufacturing. He has worked in all aspects of the product chain, from drug substance through distribution for clinical and commercial products on the business’s operations and quality sides. In his current role, he is leading a project to modernize and automate the batch release quality system for Vertex Pharmaceuticals.

Ali works within the clinical operations team at Vitaflo International Ltd as global clinical data and biometrics manager. She is responsible for all aspects of data management and statistics for the Vitaflo clinical trial portfolio. Ali has a wealth of clinical research experience having begun her data management career in 1996 and has previously worked in various data management roles in the pharmaceutical industry, academia, NHS and CRO.

As vice president of service delivery at Zifo, Narasimhan leads a team of 450+ professionals that provide Scientific Informatics Services to 50+ global customers.
Narasimhan specializes in lab informatics, data engineering, cloud and high-performance computing for scientific applications, automation, and master data set up for LIMS.

Martin is an experienced IT and digital professional with a track record of various successful digital, IT, and business transformations. He enjoys building up IT and digital teams that can truly improve the business. Only with high-performing teams can sustainable success be achieved.

AJ has been at Veeva Systems 2.5 years, serving first as a Services Consultant and now as a Solution Engineer. His experience as a back end consultant has contributed to his success as a Solution Engineer, allowing him to speak about Veeva products at a deep level.

Andrea Grau is a solution consultant specializing in R&D clinical operations across Europe. With over five and a half years of experience in life sciences R&D, Andrea brings a deep understanding of the industry’s complexities. Prior to joining Veeva, she worked at a leading CRO, where she managed global phase I-II clinical trials in oncology and rare diseases. Andrea holds a BSc in Biomedical Engineering from Pompeu Fabra University and an MSc in Industrial Management and Innovation from Uppsala University, equipping her with a strong foundation in both technical and strategic aspects of R&D operations.

Andy leads AI Solutions and the Common Data Architecture (CDA) for Veeva. Andy’s team is focused on defining and delivering AI-enabled products and solutions. He has more than 25 years of enterprise software experience and has held product positions at NextLabs, Siebel Systems, and Accenture.

Annie is a product manager on the Clinical Operations team. She is responsible for designing and delivering capabilities for Veeva CTMS. Before joining this team, Annie spent a several years as a professional services consultant where she implemented clinical operations for a variety of life sciences companies.

Ardit is a Regulatory Engagement Manager within Veeva’s R&D Business Consulting team and leads global RIM implementations and complex business transformation programs.

He has 10+ years of management consulting experience, working with leading pharmaceutical & biotech companies. He has previously led global MDM implementations outside of Veeva.

Ashley has nearly fifteen years of experience in life sciences technology, including over nine years at Veeva. As Senior Director of Veeva LIMS Strategy, Ashley is responsible for go-to-market strategy, customer engagement, and business development for the Veeva LIMS application. During her time at Veeva she has led growth strategy for the quality space across several different products and markets. Before Veeva, she served as industry solution manager for the pharmaceutical industry at Sparta Systems.

Brian heads up 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 foundered Propel Software, a PLM and QMS solutions provider and held Product Management roles at Apeel Sciences, Equilar, and Oracle.

Carl leads product strategy for Veeva QMS, bringing over 25 years of experience delivering transformative solutions across life sciences, consumer products, discrete manufacturing, and financial services. With over 20 years dedicated to quality management systems, he’s experienced over 200 quality and regulatory system design and implementation projects. Carl focuses on helping organizations meet regulatory requirements, address business challenges, and enhance 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.

Chris joined Veeva in March of 2024 and has been focused on Validation Management within the Veeva Quality Cloud. Before joining Veeva, Chris spent the last 20 years focused on validation, environmental, health and quality enterprise SAAS applications as both a product manager and solution architect. Chris is passionate about solving industry problems through solutions that customers love to use and helping move the life science industry forward.

Crystal is a Government Strategist at Veeva Systems, leading efforts to modernize data and submission standards. With leadership experience at the FDA and Booz Allen Hamilton, she specializes in regulatory submissions, data modernization, decision support, and interoperability. Passionate about leveraging technology for better healthcare outcomes, Crystal focuses on optimizing health IT solutions and improving decision-making through data.

Dorian is a product expert on the clinical operations team. His main goals are product communication and education for the clinical operations suite. With 10+ years of clinical experience, he joined Veeva as a clinical services consultant. He has extensive experience in European clinical operations and is ICH—GCP certified.

As Vice President of Product Management for Veeva Safety, Eldar leads the product teams for Safety, SafetyDocs, Safety Workbench, and Safety Signal, focusing on transforming the safety landscape through innovation and developing world-class applications. A seasoned software 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, he dedicated his career to solving complex challenges using cutting-edge technologies across a range of industries.

Elisha is a solution consultant with specialized expertise in LIMS. Throughout her career, Elisha has served as an end-user, a system administrator, and a technical consultant for LIMS in diagnostic laboratory settings. She focuses on deeply understanding customers’ pain points and discrete business challenges and ensuring the solution is well understood by showcasing Veeva LIMS. She has delivered tailored solutions designed to address customers’ individual needs, optimize laboratory processes, and enhance operational efficiency.

Eric is the product lead for Veeva SafetyDocs. Eric was previously a product manager on the Veeva Safety team, working on features across Veeva Safety Management. The main areas he worked on in core Safety are follow-up, SDK, narratives, medical review timeline, distributions, and correspondence.

Erin has worked on educational technology products for the past 12 years in the government, enterprise, and university sectors. Her product mantra is, “Can this be simpler? Then make it simpler.”

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

Florent Lusardi is a product expert supporting the clinical product suite in Europe. With over 20 years of experience in the life sciences industry, he has worked with both CROs and clinical trials technology providers. His background spans engineering, technology services and consulting, and product management. His experience gives him a broad and deep understanding of the industry’s technology landscape and business processes, particularly in CTMS and clinical operations.

Florian Letourneux is a Senior Product Expert at Veeva, supporting early adopters of Veeva Safety Signal and Safety Workbench in Europe. With 8 years of experience designing and delivering SaaS solutions for the life sciences industry across North America and Europe, he previously led the case intake product for Veeva Safety.

Francesca is a senior solution consultant for Veeva clinical operations in Europe. Over the last 10 years, Francesca has focused on increasing clinical development productivity through technology adoption and operating model improvements.
She has more than a decade of experience working in the life sciences industry from a technology vendor perspective and brings extensive experience in pre-sales and sales for cloud-based solutions. Before Veeva, Francesca held sales roles at Teckro, a technology company in the clinical space, where she was responsible for business development and product adoption.

With over 20 years of experience in clinical operations, specializing in study start-up and TMF management, he has worked closely with customers to optimize trial delivery. Passionate about supporting clinical trial sites, he focuses on developing innovative solutions to address their challenges and enhance efficiency in trial execution. His expertise lies in streamlining processes and leveraging technology to improve site engagement and trial success.

Before joining Veeva in 2015, Graham was a consultant at L.E.K. Consulting and an investor at Upfront Ventures. He holds bachelor’s degrees in Economics and Business from the University of California, Berkeley, and a master’s degree in Computer Science from the University of Illinois, Urbana-Champaign.

Graham is the general manager of Veeva LearnGxP, where he leads product strategy, customer engagement, and business development. With over 20 years of experience in the life sciences industry, he has held key roles in quality and manufacturing at leading organizations, including Pfizer, Merck, and Johnson & Johnson. His expertise spans regulatory compliance, operational excellence, and digital transformation within the sector.

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.

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.

John Tanner is a Senior Product Manager at Veeva based in the UK working in the RIM Product Management Team, specializing in connecting RIM to other Veeva applications. He is focused on delivering an enhanced change management process between QMS and Regulatory, in addition to connecting product data across the Veeva ecosystem. John has a strong background in implementation, systems integration and development following over 25 years’ experience in IT working across a number of market sectors.

Jon joined Veeva in May 2014 and has worked on several parts of the Vault Platform including Search, Jobs, User Management, Audit Trail and more. He currently leads a product management team focused on documents, renditions, search and annotations. Prior to Veeva, he spent 6 years working on the Search Intelligence team at Ask.com which built Q&A services that could directly answer many of the questions asked by users on the site.

Jordan Williams is a Product Manager dedicated to helping pharmaceutical and biotech companies streamline their regulatory submissions. Recognizing the significant impact of ICH eCTD 4.0, Jordan has dedicated his time to understanding the nuances of this new standard and its implications for the industry. Attend this session to benefit from Jordan’s expertise and learn how to effectively prepare for and implement ICH eCTD 4.0, ultimately saving time and resources in your regulatory submissions process.

Joseph is an accomplished healthcare professional who has held leadership positions at major clinical research organizations, including IQVIA, Chiltern, PRA Health Sciences, and Biotrial, before joining Veeva as a solution consultant. Throughout his career, he has developed expertise in clinical operations, managing global teams, and driving strategic initiatives that improve clinical trial processes. His extensive background in the pharmaceutical industry has positioned him as a valuable resource for life sciences customers seeking to implement cloud-based solutions that enhance their clinical development workflows.

Katerina has been working in the Regulatory space since 2014, firstly as a Regulatory Affairs Project Manager, leading customer projects to register or maintain Marketing Authorisations, and now in the role of a Solution Consultant for Veeva RIM. With industry experience and a deep understanding of customer needs and pain points, Katerina enjoys showcasing solutions that add value to regulatory teams’ daily work.

As a Product Expert, Kris is responsible for continuously educating Customers, Partners, and Services on the features, best practices, and general knowledge for the Vault Platform. His areas of expertise include DevOps, Configuration and Data Migration, and Release Management.

Kyle started his career regularly using Veeva systems at a medical device company. He fell in love with the product and joined Veeva as an associate consultant. Now, after nine years with Veeva, Kyle is a director of product who leads a team responsible for the development of the core and emerging Clinical Operations applications; eTMF, Study Startup, Site Connect and Open Data Clinical.

Lucas worked at Veeva as a Consultant for the last 6 years, with heavy background in R&D solutions and Veeva Connections. Developed connection implementations across the DevCloud and Commercial Clouds. Now working in the EU DevCloud Strategy team to help Veeva develop the technology foundation for product development.

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 MS in computer science from Boston University and a BBA in MIS from the University of Texas at Austin.

As a trained biochemist Marcel brings a diverse background spanning scientific research, pharmaceutical start-up experience, and several years at the Boston Consulting Group advising global biopharma on R&D and digital strategy. As an Engagement Manager in EU R&D Business Consulting, his focus is on Development Excellence to help industry leaders work more efficiently (e..g, through best-fit operating models or solving for cross-domain challenges).

Marius is the product architect for Veeva Safety, focused on helping the life sciences industry innovate and solve complex problems. Since 2017, Marius has been on mission to modernize pharmacovigilance on one unified system, drawing upon his 20 years of experience in building world-class products and platforms towards this goal. Prior to joining Veeva in 2015, Marius worked at a leading FinTech, where he built their enterprise lending compliance platform and designed their next-generation products.

Mark is responsible for helping enrich the Developer Experience for Veeva Vault. He works with customers, partners, services, and product teams to ensure Vault Developers have a seamless and productive experience.

Mercedes is a biotechnologist with more than 10 years of experience in the pharmaceutical industry, specializing in regulatory affairs. She has been working at Veeva for the past two years, contributing to the digital transformation of the sector. Her career combines scientific and regulatory expertise to optimize processes in the healthcare industry.

Mike’s focus is on providing education on Platform functionality through our Veeva Connect Communities and helping ensure that Veeva customers have the best possible information to adopt and leverage Vault Platform functionality. Within the Platform team, Mike works closely with the PMs an‍d Product Experts, focusing specifically on Docs, Reporting, Email/Notifications, EDLs, and Security.

Michelle Marlborough is the SVP of Product Management for Sites and Patients at Veeva. She has over 25 years of experience in life sciences and software development, with a passion for transforming clinical trials through innovative technology and analytics. At Veeva, Michelle is globally responsible for the product design, development and success of eCOA.

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.

After having completed her Pharmacology BSc and PhD, Nicholl has spent the last 13 years focused on helping clients within R&D life sciences get drugs to patients faster by consulting in the CRO setting. Nicholl has collaborated with KOLs at Tufts University to develop methodologies to assess site, patient, and sponsor burden of clinical protocols. She has also supported clients with change management and end-user -training during their digital transformations.

Oliver comes from a background of Biomedical Sciences, and has been working with the Vault Platform for the last 8 years. He has a passion for understanding and improving patient outcomes in healthcare.

Pinar Bérénice Bénet is a senior director of EU strategy for clinical operations at Veeva Systems. She has 15+ years of experience in the life sciences industry in clinical, medical, and commercial operations. Before joining Veeva, she consulted on strategy design for life sciences product launches across EMEA. She also worked at various CROs focusing on patient-site solutions. These experiences helped her better understand the operational challenges sponsors face in executing their clinical trials.

Rachael Wax is a solution consultant in the clinical operations space with a strong background in the industry, having previously held roles as a clinical research coordinator, CRA, and CTA before joining Veeva. She is passionate about helping ClinOps teams optimize their processes, enhancing efficiency in study management, and driving impactful solutions for clinical trials.

Rachel is a member of the Regulatory Strategy team, looking after large customers in Europe and helping them to increase the value they get from Veeva RIM. She has been working in the Pharma industry for more than 30 years helping organisations to implement and enhance regulatory processes through efficient use of technology.

For the past 8 years, Ray has run Product for the EDC and CDB products at Veeva, helping Veeva to grow its Clinical Data business from scratch to where it is now. He has over 30 years of experience design and developing software for the enterprise and has been working in Clinical Data Management since 2012 when he was the COO and head of product at another EDC company. Prior to that, he worked in FinTech on low-latency and high-volume quantitative electronic equities trading.

Rich is a strategic thought leader in life sciences technology, specializing in regulatory information management. His extensive experience has been instrumental in developing innovative software solutions that empower organizations to accelerate time-to-market while ensuring compliance. At Veeva, he leads the product management team responsible for Veeva RIM, driving the future of regulatory solutions.

Stephen has product management responsibilities for the Veeva QualityDocs, Station Manager and Training products within the Quality Cloud. He along with his dedicated team of product managers are focused on building excellent features across these products that solve our customer’s needs. Prior to joining Veeva, he spent almost 15 years at a healthcare technology company working on electronic medical record products.

Thilo was born and raised in Germany and is a trained medical doctor and health economist. Before joining Veeva’s Development Cloud Strategy Team, he was a Business Consultant at McKinsey & Company.

Tristram leads the Safety Signal and Safety Workbench applications. He has worked in product management on data and analytics platforms for over 15 years across a number of industries.

Dedicated Team Leader with a demonstrated history of working in the Life Sciences Software industry. Passionate about fostering good ideas to innovate within the Life Science space, ultimately getting treatments to patients faster. Eager to apply technical and industry expertise to support sponsors in doing what they do best.

Valeria is a Regulatory Professional with nearly 20 years of experience in the Life Science industry across business, academia, and consulting. Outside of work, she is a TOPRA fellow and a proud mother of twins.

Vicki is the Strategy lead for Veeva RIM in Europe responsible for the success of Contract Services, Manufacturing and Generics organisations who utilise Veeva RIM. Vicki pulls on a 20+ year career in Regulatory working within industry, consulting and in the CRO landscape which enables her to be the successful bridge between technology and the business. At Veeva she is responsible for the strategy and direction in Regulatory, helping customers to transform their business through successful Veeva RIM adoption.

Waseem Awad is the EU Development Excellence (DevEx) Practice lead for Veeva Business Consulting. His mandate is centered around supporting the growth of our clients by harnessing the power of the Veeva platform through cross-functional governance/ operating models, development-wide value realization, cross-vault strategic efficiencies, data strategy and connections.

Werner is a senior director in clinical strategy with 20+ years of experience in the pharmaceutical and life sciences industry, including roles in early-stage development, post-approval life-cycle management, and in the healthcare environment. His career began as an investigator at the University Hospital Vienna and later transitioned into the pharmaceutical industry. After a role as an assessor for vaccines at the Austrian Regulatory Authority, he entered the CRO industry and spent the last 12 years in operational, sales, and account management roles.