See you in Madrid next year!
See you in Madrid next year!
Gerd Schlueter
Bayer
VP RA Strategic & Technical Operations
Gerd Schlueter
Bayer
VP RA Strategic & Technical Operations
Gerd has broad experience in different functions in regulatory affairs, including regulatory strategies with managing several global approvals for NCEs in various therapeutic areas. Since 2017, he has overseen global operations covering IT systems, submissions, quality management, labeling, and strategic outsourcing activities.
Hugo Cervantes
Veeva Systems
VP, Vault Clinical
Hugo Cervantes
Veeva Systems
VP, Vault Clinical
Hugo is responsible for Vault Clinical strategy in Europe and the successful adoption of Vault Clinical solutions by Veeva’s larger European headquartered customers.
Over the last 20 years Hugo has focused on increasing Clinical Development productivity through technology adoption and operating model improvements. Hugo’s career has spanned technology implementation at Phase Forward, management consulting at Accenture and Deloitte and corporate strategy at Quintiles, prior to joining Veeva in 2016.
Robert Gaertner
Veeva Systems
VP, Quality Strategy, EU
Robert Gaertner
Veeva Systems
VP, Quality Strategy, EU
Robert is the VP of Quality Strategy, EU at Veeva Systems. With more than 20 years of experience in the life sciences industry, he is a recognised expert in quality processes and systems. Starting his career in the industry, Robert moved to consulting and led large quality implementation programs, including eDMS, eQMS and LIMS for a number of top pharma companies. As a subject matter expert and industry consultant, Robert has worked for leading companies including PwC Consulting, IBM, Lodestone, and Infosys. In his current role at Veeva, Robert is responsible for a small but growing team of highly engaged Quality Strategists. Our team is defining the strategy and supporting the growth of Vault Quality in our region.
Rik Van Mol
Veeva Systems
SVP Development Cloud
Rik Van Mol
Veeva Systems
SVP Development Cloud
Rik is responsible for the vision, direction and European market of the Veeva Development Cloud across R&D and Quality. He is a senior executive with over 20 years of experience in management consulting and cloud software in the life sciences/pharmaceutical sector. He is known for assisting clients through complex transformation programs across the life sciences value chain. Rik is a recognised thought leader with deep expertise in architecting, launching, and implementing innovative and industry-leading strategies and solutions.
Richard Young
Veeva Systems
VP, Strategy, Vault CDMS
Richard Young
Veeva Systems
VP, Strategy, Vault CDMS
Richard is VP of strategy for Vault CDMS and a 25-year veteran in life sciences. Richard is responsible for defining the strategy and direction for Vault CDMS, especially concerning clinical data management. Richard brings Veeva customers a keen executive vision and proven operational experience in data management, eClinical solutions, and advanced clinical strategies.
GSK, Recordati, Syneos Health: Building Better Trials for All
Tuesday 11:00 CEST
End-to-End Digital Trials with Veeva
Tuesday 17:00 CEST
Paul Attridge
Veeva Systems
VP Vault RIM, Enterprise
Paul Attridge
Veeva Systems
VP Vault RIM, Enterprise
A technologist and business development professional whose experience spans 37 years, eight years initially as a Software Engineer and most recently 29 years dedicated to the Life Sciences industry. In his current role, he leads Veeva System’s strategy activities in Europe for their Enterprise Regulatory customers to help them leverage their innovative Vault RIM product suite. Previous roles have also included Business Development, Product Management, Product Architecture, Software Development and Professional Services at DxC, CSC and FCG.
Michael Jovanis
Veeva Systems
VP, Vault Quality & Manufacturing
Michael Jovanis
Veeva Systems
VP, Vault Quality & Manufacturing
As Vice President of the Vault Quality product suite, Mike is responsible for product strategy, customer engagement, and business development. Previously, he served as Vice President of Product Management and Strategy for Sparta Systems, where he was instrumental in the company’s rapid growth, driving product development, vertical market strategy, and strategic partner alliances. He is educated at Rutgers and holds a bachelor’s degree in marketing and an MBA in strategy and global business.
Jared Katz
Veeva Systems
Development Cloud Architect, Strategy
Jared Katz
Veeva Systems
Development Cloud Architect, Strategy
Jared is a Director of Strategy at Veeva, working across the Development Cloud applications. In his role, Jared brings together cross-functional application teams to ensure a holistic approach is delivered in strategy, product, and services. Before moving to the strategy team at Veeva, Jared ran a team responsible for scoping and planning application implementations. In addition to his years in life sciences, Jared brings experience from prior consulting roles at Epic delivering electronic medical records systems to hospitals.
Boehringer Ingelheim: The Evolution of Operations with Veeva
Tuesday 11:00 CEST
Driving Enterprise Efficiency with Vault Connections
Tuesday 17:00 CEST
James Reilly
Veeva Systems
VP, Development Cloud Strategy
James Reilly
Veeva Systems
VP, Development Cloud Strategy
As Vice President of Vault Development Cloud at Veeva, Jim leads a global team responsible for customer engagement, market adoption, and strategic alliances. For the last 20 years, Jim has held a variety of senior positions in life sciences technology and consulting, where he has led software delivery and sales efforts in clinical operations, regulatory, clinical data standards, and content management.
Chris Moore
Veeva Systems
President, Veeva Europe
Chris Moore
Veeva Systems
President, Veeva Europe
As president of Veeva Europe, Chris is responsible for growing the business in the region. A 32-year veteran of the life sciences industry, Chris started his career at ICI Pharmaceuticals (now AstraZeneca). Chris then joined a start-up called Kinesis, building a team delivering document management solutions for pharmaceutical companies. Through a series of mergers and acquisitions, Kinesis ultimately became PwC; Chris made a partner with PwC in 2001. Chris went on to run both European and US (West Coast) life sciences businesses for IBM before leading the IBM global life sciences consulting Business Analytics and Optimization unit. Most recently, Chris was the lead partner for life sciences for Europe, the Middle East, and Africa at EY. Chris holds a bachelor of science degree in information technology from the University of Salford.
Opening Keynote:
Delivering for Patients: Innovation in R&D and Quality
Tuesday 9:30 CEST
Closing Keynote
Heart to Heart: The Voice of the Patient for Better Outcomes
Wednesday 14:15 CEST
Martin Helling
Boehringer Ingelheim
Executive Director – Program Manager One Medicine Platform
Martin Helling
Boehringer Ingelheim
Executive Director – Program Manager One Medicine Platform
After 12 years in consulting, Martin joined Boehringer Ingelheim in 2013. He headed several different areas of IT including data integration, migration, and content management. In 2022 Martin took over the program management of BI’s One Medicine Platform. As part of this project, he is implementing Veeva Vault across multiple areas including clinical, quality, and regulatory affairs.
Avril England
Veeva Systems
General Manager, Vault
Avril England
Veeva Systems
General Manager, Vault
Avril England is the general manager of Veeva Vault, a fast-growing cloud software platform and suite of applications to manage content, data, and business processes for life sciences and other regulated industries. Under Avril’s leadership, Veeva Vault has grown to represent 40% of Veeva revenues. Avril has more than 20 years of experience building and scaling product teams, including 15 years at innovative software-as-a-service companies. She was a key contributor in two successful IPOs and played leadership roles at world-class organizations including Oracle’s PeopleSoft, Cisco’s WebEx, and IBM’s DemandTec. Avril holds a bachelor of commerce honors degree from Queen’s University in Ontario, Canada, and has received numerous professional and academic awards.
Trevor Griffiths
Syneos Health
Snr Director, Clinical Data Management
Trevor Griffiths
Syneos Health
Snr Director, Clinical Data Management
Trevor is a senior leader at Syneos Health and oversees biometrics partnerships with strategic partners. Trevor has been with the company for over 24 years serving in many leadership positions within data management, programming, biostatistics, and medical writing. Trevor led the implementation of Veeva Vault CDMS at Syneos Health and has supported multiple pharma companies in their adoption of Veeva CDMS.
Emma Forrest
Recordati
Head of Clinical Operations and Project Management
Emma Forrest
Recordati
Head of Clinical Operations and Project Management
As head of clinical operations and project management at Recordati, Emma leads global cross-functional R&D teams responsible for project execution in cooperation with project leaders and affiliates. She is also responsible for implementing the project management office (PMO) and strategic program management processes. Emma is passionate about creating a safe working environment and leading teams to share knowledge and leverage technology to bring medicines to patients faster.
GSK, Recordati, Syneos Health: Building Better Trials for All
Tuesday 11:00 CEST
Recordati: Preparing for the Digital Future with Vault Clinical Suite
Tuesday 15:30 CEST
Nick Hartshorne-Evans
Pumping Marvellous Foundation
Founder/CEO
Nick Hartshorne-Evans
Pumping Marvellous Foundation
Founder/CEO
Nick was diagnosed with heart failure in January 2010 at 39. His patient experience led him to develop the Pumping Marvellous Foundation, a globally significant third-sector heart failure charity in the UK. Nick regularly engages in patient advocacy globally and delivers patient-led collaborative solutions nationally. He is known as a key opinion leader in heart failure patient advocacy.
Closing Keynote
Heart to Heart: The Voice of the Patient for Better Outcomes
Wednesday 14:15 CEST
Pilar Carrero
LEO Pharma A/S
Vice President, Global Safety
Pilar Carrero
LEO Pharma A/S
Vice President, Global Safety
Pilar is a medical doctor with a Ph.D. in biochemistry and molecular biology and over 20 years of experience in the pharmaceutical industry. She has dedicated 15 years to research in both academia and industry, working in metabolic diseases and oncology, and 17 years in multiple roles in pharmacovigilance where she led the implementation of optimization activities in processes and systems. Pilar currently leads Global Safety at LEO Pharma, where the area has embarked on the implementation of a new safety platform. Pilar is passionate about new technologies and their application to transform the way we work.
Nicolas Maldonado
Gilead Sciences
Executive Director, Global Quality Systems and Compliance
Nicolas Maldonado
Gilead Sciences
Executive Director, Global Quality Systems and Compliance
Nicolas is an experienced quality and compliance strategic leader and change agent with over 30 years of global, well-rounded experience in immunodiagnostics, biopharma, biotech, and medical devices and with an outstanding record for business acumen, driving compliance, and operational success. He leads large-scale transformational changes to grow business and organizational capacity.
Tony Lewis
GSK
Director, Trial Operations Product Owner
Tony Lewis
GSK
Director, Trial Operations Product Owner
Tony has worked in biopharma technology for over 25 years. He spent nine years implementing lab, screening, and chemistry solutions at Merck & Co., followed by 17 years delivering and managing clinical operations systems at GSK. He is passionate about building solutions and capabilities to optimize clinical operations processes.
Sharmila Sabaratnam
Veeva Systems
Senior Director, Vault Safety Strategy EU
Sharmila Sabaratnam
Veeva Systems
Senior Director, Vault Safety Strategy EU
Sharmila Sabaratnam is a Senior Director at Veeva Systems responsible for EU SMB Vault Safety Strategy helping customers to transform their business through unified safety platform adoption. Physiologist by training with research experience within oncology and arthritis. She has 15+ years’ experience within safety, previously leading safety and regulatory advisory services for Top-25 and Top-100 companies within Ernst & Young and Navitas. Her experience includes operating model design and safety strategy, PV automation, benefit-risk management and performance benchmarking. As a senior leader within the NHS, led R&D clinical operations with a large oncology clinical trials portfolio, including the Biomedical Centre for Translational Research.
Helen Ball
ADVANZ PHARMA
Senior Specialist: Systems and Data Management
Helen Ball
ADVANZ PHARMA
Senior Specialist: Systems and Data Management
Helen has over 20 years of experience in the UK pharmaceutical industry, having previously worked in quality roles at Teva and Novartis before joining Advanz Pharma in 2011. After holding various QMS roles over the past 11 years, she is now responsible for the ongoing development and continuous improvement projects for the Veeva Quality and RIM Vaults.
Peter Brandstetter
Accenture AG
EU Quality Lead
Peter Brandstetter
Accenture AG
EU Quality Lead
Peter has over two decades of experience solving complex IT challenges for pharmaceutical companies globally. He has held many senior life sciences consulting and IT roles, including life science central region lead at CSC, senior managing consultant for GBS Life Sciences at IBM, and senior manager at PwC. Peter specializes in quality management and quality assurance in manufacturing and R&D, enterprise content management, and R&D, as well as computer validation.
Accenture and Veeva: Optimizing End-to-End Quality with Unified QA and QC
Wednesday 11:00 CEST
Mitesh Vora
Accenture
EU Veeva Delivery Lead
Mitesh Vora
Accenture
EU Veeva Delivery Lead
Mitesh supports clients with implementation plans, strategic road mapping, and working methods designed around Veeva and GxP. He has worked with Veeva for over six years and has developed experience around risk mitigation and core considerations before starting an implementation. Mitesh is interested in SAFe methodology and technology, combining those two to design a hybrid delivery methodology that caters to the Vault technology and adheres to GxP compliance.
Connect: Accelerating Validation through Agile Ways of Working with Accenture
Tuesday 16:30 CEST
Chus Castillo
Alira Health
Partner, Iberia
Chus Castillo
Alira Health
Partner, Iberia
Chus is a professional in the pharmaceutical and life sciences sector. He has expertise in market access solutions, pricing solutions, public relations, and public affairs. Chus has also worked on commercial management focused on both marketing and sales.
Giovanni Firenze
Alira Health
Partner, Italy
Giovanni Firenze
Alira Health
Partner, Italy
Giovanni has 25 years of experience in pharmaceutical and management consulting in the life sciences. He started his career at Eli Lilly and later moved to Bristol Myers Squibb. Since 2002 he has worked in management consulting roles at Accenture, Arthur D. Little International, IMS Health Consulting Group, Executive Insight, HBI Consulting, Vintura, and Alira Health.
Cherith Wallace
Almac Clinical Services
Global Quality Systems Manager
Cherith Wallace
Almac Clinical Services
Global Quality Systems Manager
Cherith manages a portfolio of systems that support the pharmaceutical quality system, such as document management, master documentation generation, true copy, and product classification. Cherith has 25 years of experience designing, implementing, and maintaining these systems and has recently led the implementation of Vault QMS. Having supported multiple regulatory inspections, Cherith has a wealth of experience in how to meet regulatory expectations. She is passionate about delivering simplistic, compliant solutions that achieve results.
Isabelle De Montazet
Alvotech
Director Regulatory Information Management
Isabelle De Montazet
Alvotech
Director Regulatory Information Management
Isabelle has over 23 years of experience in regulatory operations. She is responsible for the Veeva Vault implementation at Alvotech and played an integral role in the eSubmission strategy. Isabelle has proven experience managing projects related to regulatory affairs systems and data, new system implementations, upgrades, data migration, and preparation for new legislation.
Arturs Auzins
AstraZeneca
Release Management Lead – Operational Clinical Development
Arturs Auzins
AstraZeneca
Release Management Lead – Operational Clinical Development
Arturs is an IT professional with proven expertise in release management and engineering, IT quality, and GxP validation, with associated competencies in project and product management in pharmaceutical companies. As a release manager for the Veeva Vault clinical platform at AstraZeneca, he is responsible for delivery excellence and operational governance.
Rafal Czarnocki
AstraZeneca
VCV Business Platform Lead
Rafal Czarnocki
AstraZeneca
VCV Business Platform Lead
Rafal has almost 20 years of experience in various areas of clinical trials. He focuses mainly on site management, risk-based monitoring, and study systems, especially CTMS. Rafal earned a Ph.D. in Chemical Engineering from the Warsaw University of Technology.
Mark Davies Karvonen
Bayer Consumer Health
Global Product Manager
Mark Davies Karvonen
Bayer Consumer Health
Global Product Manager
Mark has over 20 years of experience in healthcare driving digital technology solutions for global companies. With a passion for digital transformation, Mark is currently the global product manager for Veeva Vault RIM for Bayer Consumer Care AG.
Bayer Consumer Health: Partnering with Veeva Business Consulting to Drive Value Realization
Wednesday 11:00 CEST
Ellen Vanderlinden
Bayer
Sub Head Training Change & Communication
Ellen Vanderlinden
Bayer
Sub Head Training Change & Communication
Ellen has several years of experience in local and global clinical trial management. During the last five years, she has established a team to support a study-specific training strategy which includes setting the vision and technology for a multi-method and customer-oriented approach to support the successful conduct of clinical trials. Ellen currently leads the implementation of Veeva Study Training at Bayer.
Bayer: Bringing Together Learning Management and Clinical Operations to Drive Inspection Readiness
Wednesday 11:00 CEST
Emma Earl
Bayer
Head of Systems Support
Emma Earl
Bayer
Head of Systems Support
Emma has over 20 years of experience in the biopharmaceutical 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. Emma heads a team of system managers and specialists responsible for implementing, maintaining, and supporting critical systems utilized by clinical development operations, including Veeva Vault Clinical and Vault Study Training.
Alexander Wolff
Boehringer Ingelheim
Senior Regulatory Information Manager
Alexander Wolff
Boehringer Ingelheim
Senior Regulatory Information Manager
Alexander is passionate about digitalization, people, and agility, which drove him to be part of Boehringer Ingelheim’s thriving One Medicine Platform. As product owner of Veeva Vault RIM, he embraces and advocates for an agile mindset and rethinking historic process approaches. Alexander has spent much of his career in regulatory affairs with experience in eCTD, product information management, xEVMPD, IDMP, and multiple rounds of EDMS replacements.
Boehringer Ingelheim: Weaving the Regulatory Fabric for Unified Medicine
Tuesday 13:30 CEST
Birgit Huwer
Boehringer Ingelheim
Release Train Lead – RIM Vault
Birgit Huwer
Boehringer Ingelheim
Release Train Lead – RIM Vault
Birgit’s 27-year career started in regulatory operations, where she has been responsible for implementing, supporting, and maintaining regulatory systems. She and a strong, motivated team are now responsible for implementing the Veeva regulatory suite at Boehringer Ingelheim.
Boehringer Ingelheim: Weaving the Regulatory Fabric for Unified Medicine
Tuesday 13:30 CEST
Idowu Amusu
Bristol Myers Squibb
Senior Manager PSMF Office
Idowu Amusu
Bristol Myers Squibb
Senior Manager PSMF Office
Idowu has 13 years of experience in the transformation of strategic pharmacovigilance. During his career, he specialized in risk management, case management, and safety operations and worked to ensure patient safety and streamline regulatory approval processes across the globe. In the past eight years at Bristol Myers Squibb, Idowu has developed and maintained the Global Pharmacovigilance System Masterfile (PSMF) and nine local PSMFs.
Bristol Myers Squibb: PSMF Management – Transformation Journey and Adoption Lessons
Tuesday 13:30 CEST
Rabiah Choudhary
CRISPR Therapeutics
Manager, Global Pharmacovigilance
Rabiah Choudhary
CRISPR Therapeutics
Manager, Global Pharmacovigilance
Rabiah has over eight years of experience across large biotechnologies and pharmaceutical companies. Rabiah has expertise in the industry ranging from pre-clinical pharmacology studies to pharmacovigilance, clinical trials, and post-marketing. Currently, she is leading several immuno-oncology and regenerative medicine programs and further developing the PV infrastructure at CRISPR Therapeutics.
Stefan Brügger
Ferring Pharmaceuticals
Senior Director, Global Regulatory Operations
Stefan Brügger
Ferring Pharmaceuticals
Senior Director, Global Regulatory Operations
Stefan joined Ferring in 2019 and heads up global regulatory operations. He has held different leadership roles in the life sciences throughout his career, mostly in mid-size to large pharmaceutical companies but also in consulting roles. Stefan’s expertise lies in navigating the challenges at the convergence of business processes and IT.
Jerry Yarem
Fortrea
Vice President, Data Management
Jerry Yarem
Fortrea
Vice President, Data Management
Jerry has more than two decades of experience in clinical data management, including more than 10 years in leadership roles for global organizations. During his time in life sciences, he has focused on transforming cross-functional collaboration and leveraging technology to drive high-performing teams.
Jarek Tanski
GSK
Director, Country & SIte Activation
Jarek Tanski
GSK
Director, Country & SIte Activation
Jarek has led various facets of regulatory affairs and study start-up throughout his career. Currently, he is the director of country and site activation at GSK. There has had a critical role in designing agile site activation processes and leading a global team to achieve upper-quartile study start performance.
John Reilly
GSK
Head Veeva CoE
John Reilly
GSK
Head Veeva CoE
John is an established transformational change leader. He has led enterprise-level programs in several global support functions (procurement, IT, HR/learning, corporate strategy office, global ethics, and compliance) and, most recently, R&D clinical operations.
Fiona Glenny
Genmab
Associate Director, Process and Training Management
Fiona Glenny
Genmab
Associate Director, Process and Training Management
Over Fiona’s 25-year career in the pharmaceutical industry, she worked across R&D processes, e-system implementation, and marketing while developing as a training expert. During the last five years, Fiona led the company’s implementation of Veeva Quality and RIM suites, concluding with Vault Training in 2021. Now, as part of a small team of dedicated training professionals, her mission is to build a training framework supporting role-based qualification and leading the strategic development of Genmab’s Learning Management System.
Jennifer Trundle
Gilead Sciences
Director, Quality Information Systems
Jennifer Trundle
Gilead Sciences
Director, Quality Information Systems
Jennifer is the director of quality information systems at Gilead Sciences, where her team provides business ownership of QualityDocs, Vault QMS, and the GxP Learning Management System. Jennifer is driving Gilead’s strategy of transforming and integrating their enterprise-wide quality systems. After modernizing document management and QMS, Jennifer led an evaluation of Vault Training in pursuit of Gilead’s next objective: revamping GxP Training and completing the “trifecta” of interconnected quality systems. Jennifer was recognized as a Veeva Hero in 2019.
Aine Drohan
Haleon
Veeva Quality Vault Specialist
Aine Drohan
Haleon
Veeva Quality Vault Specialist
Aine manages user requirements, sprint and release planning, incident reviews, and test execution at Haleon. She supports the Veeva Vault Quality communication and engagement plan and is accountable for procedural and training content development and maintenance.
Laura Sinden
Haleon
Quality Vault Lead
Laura Sinden
Haleon
Quality Vault Lead
Laura leads the Quality Vault team at Haleon, having spent most of her career in consumer health. She started her Veeva journey as the implementation lead for the VQMS application in 2021, closely followed by taking on the role of the product owner and managing the lifecycle of the Quality Vault – both VQMS & QualityDocs. Most recently, she led the successful implementation of the RIMS-VQMS integration and SAP-VQMS interface.
Haleon: Increasing Operational Efficiency through Vault Connections and End-to-End Integrations
Tuesday 17:00 CEST
Anna Weill
Idorsia Pharmaceuticals Ltd
Business Systems Analyst
Anna Weill
Idorsia Pharmaceuticals Ltd
Business Systems Analyst
Anna holds a master’s in library and information science and has over a decade of experience in data and information management in global organizations and pharmaceutical companies, especially in R&D and regulatory affairs. At Idorsia, Anna is responsible for maintaining, supporting, and enhancing Vault Submissions and implementing Vault Registrations.
Pavol Lím
Idorsia Pharmaceuticals Ltd
Senior Business Systems Analyst
Pavol Lím
Idorsia Pharmaceuticals Ltd
Senior Business Systems Analyst
Pavol joined Idorsia in 2019 and holds degrees in information systems management, big data systems, and strategic management. At Idorsia, he leads a team of business analysts working with Veeva Vault Quality. The team is responsible for running configuration, optimization, and integration projects.
Simone Mechler
Idorsia Pharmaceuticals Ltd
Senior Director, Team Leader Clinical & Quality Systems
Simone Mechler
Idorsia Pharmaceuticals Ltd
Senior Director, Team Leader Clinical & Quality Systems
Simone holds a degree in biology from the University of Freiburg, Germany. She has over ten years of consulting experience in pharmaceutical R&D, strategy development, process optimization and restructuring programs, and system implementations. In 2011, Simone joined Actelion Pharmaceuticals as eClinical program and change manager. She transferred to Idorsia Pharmaceuticals when the company was founded as a spin-off during the acquisition of Actelion by Johnson & Johnson in June 2017. Simone is responsible for the implementation and support of Idorsia’s clinical & quality systems landscape and is the system owner of the Veeva Vault R&D Platform.
Vincent Rolland
Idorsia Pharmaceuticals Ltd
Director, Data Management and Programming
Vincent Rolland
Idorsia Pharmaceuticals Ltd
Director, Data Management and Programming
Vincent is the director of data management at Idorsia. He graduated with a master’s degree in biology and statistics and, early in his career, worked as a clinical database programmer. He is passionate about innovation and was a key contributor to the implementation of the data systems used at Idorsia, such as the metadata repository, the statistical programming environment, and Veeva CDMS.
Basvaraj Pinna
Jeev Lifeworks LLP
Head – Engineering
Basvaraj Pinna
Jeev Lifeworks LLP
Head – Engineering
Basvaraj is a senior technology leader with over 20 years of experience in different technologies, industries, and geographies. At Jeev Lifeworks, he is responsible for building scalable, high-speed, distributed technology solutions for the life sciences.
Doug Bain
KCR
Chief Technology Officer
Doug Bain
KCR
Chief Technology Officer
Doug is the chief technology officer of KCR, responsible for the technology strategy for all KCR group entities. He comes to KCR with over 30 years of experience in developing and implementing clinical trial technology solutions. Before joining KCR, he worked for IBM, Clario (eRT), Medidata, and eClinicalHealth, specializing in next-generation clinical trial/patient and site engagement technology.
Mette Mackeprang Bartlett
LEO Pharma
Principal Data Manager
Mette Mackeprang Bartlett
LEO Pharma
Principal Data Manager
Mette was instrumental in the first use of EDC and eSource at Lundbeck. She has driven implementations, validations, and use of EDC in data management for almost 20 years in roles at Lundbeck, Novo Nordisk, LEO Pharma, and HERAX. She is an active member of various data management networks and associations, including the eClinical Forum and DIA Advisory Board.
Manfred Eis
Merck Healthcare KGaA
Head, Veeva Office
Manfred Eis
Merck Healthcare KGaA
Head, Veeva Office
Manfred leads a team of experts from business and IT at Merck KGaA. The team is part of the healthcare digital & data transformation group. They drive and implement the healthcare informatics strategy by establishing Veeva Vault as a common platform for most development activities. Manfred’s career spans over 30 years in pharma IT (regulatory operations and consulting) and basic biomedical/pharmaceutical research.
Charlotte Øbakke
NNIT
Head of Quality Europe
Charlotte Øbakke
NNIT
Head of Quality Europe
Charlotte heads up Quality Europe at NNIT and is responsible for the delivery and business development within the quality domain. Charlotte has a strong quality foundation from her 30 years in the life sciences. Charlotte aspires to bring her experience to help life science companies transform their quality management systems into best-in-class digital solutions.
Innovation Theater: Transforming 21st Century Training with Mixed Reality (Repeats)
Tuesday 12:00 CEST
Innovation Theater: Transforming 21st Century Training with Mixed Reality
Tuesday 13:00 CEST
Kasper Kronmann Nielsen
NNIT
Advisory Director – International Life Science & Digital Innovation Mixed Reality
Kasper Kronmann Nielsen
NNIT
Advisory Director – International Life Science & Digital Innovation Mixed Reality
Kasper is a seasoned management and life sciences consultant, specializing in digital transformation and innovation. Since 2018, Kasper has developed Mixed Reality services that offer innovative solutions such as 21st-century training, Digital Audit, and Lab of the Future. Most recently, Kasper contributed to the GxP recommendations from Microsoft on implementing digital learning and guidance, released in April 2023.
Innovation Theater: Transforming 21st Century Training with Mixed Reality (Repeats)
Tuesday 12:00 CEST
Innovation Theater: Transforming 21st Century Training with Mixed Reality
Tuesday 13:00 CEST
Aysegul Ozkose
Nordic Pharma
Senior Regulatory Affairs Database Manager
Aysegul Ozkose
Nordic Pharma
Senior Regulatory Affairs Database Manager
Aysegul is a pharmacist with 12 years of expertise in regulatory affairs. Currently, she is managing the RA Database Management department at Nordic Pharma. Previously she was the business owner for the Veeva RIM Registration implementation and is now responsible for the Veeva Submission Publishing and Archive implementation.
Nordic Pharma: Importance of Building a Trusted Connection Between Safety and Regulatory
Tuesday 15:30 CEST
Nilay Gupta
Nordic Pharma B.V.
IS Systems Manager
Nilay Gupta
Nordic Pharma B.V.
IS Systems Manager
Nilay is a Veeva Vault certified professional with over five years of experience in data migration, implementation, and configuration across different Vault applications. He works as a system manager at Nordic Pharma, providing IT support to Vault Safety and RIM applications.
Cecile Kaiser
Nordic Pharma
PV Senior Manager
Cecile Kaiser
Nordic Pharma
PV Senior Manager
Cecile has nearly 20 years of experience in biopharma in various pharmacovigilance roles at affiliate and corporate levels.
Nordic Pharma: Importance of Building a Trusted Connection Between Safety and Regulatory
Tuesday 15:30 CEST
Josef Jackson
Novo Nordisk
Senior Competency Development Professional
Josef Jackson
Novo Nordisk
Senior Competency Development Professional
Josef joined Novo Nordisk in 2020, and has played a key role in bridging clinical operation processes and end-user needs. His expertise centers on developing enhancements and new functionalities for Novo Nordisk’s clinical digital systems. Josef’s prior experiece includes document migration, implementation of a new CTMS, and collaboration across clinical and regulatory to support submissions.
Novo Nordisk: Implementing Process and Technology Changes to Comply with EU CTR
Tuesday 15:30 CEST
Majbritt Romme
Novo Nordisk
Senior Regulatory Professional / Process Expert
Majbritt Romme
Novo Nordisk
Senior Regulatory Professional / Process Expert
Majbritt has over 20 years of experience with various regulatory development projects working with regulatory submissions. At Novo Nordisk, she supports the digital transformation in global regulatory affairs for the submission and registration processes based on continuous optimization and development of Vault RIM and other digital solutions.
Novo Nordisk: Implementing Process and Technology Changes to Comply with EU CTR
Tuesday 15:30 CEST
Nelson Da Silva
OM Pharma
eTMF Specialist and Clinical Trial Associate Lead
Nelson Da Silva
OM Pharma
eTMF Specialist and Clinical Trial Associate Lead
Nelson has over 12 years of experience in clinical operations. He started his career and work with TMF activities at Merck Serono. Nelson gained expertise in TMF management at Quintiles while developing team management skills. He specializes in the electronic TMF process at the Drugs for Neglected Diseases initiative and has worked with Vault eTMF since 2018. Nelson currently leads the clinical trial associates team and the eTMF process at OM Pharma.
Pauline Pluviaud
OM Pharma
Drug Safety Operations Manager
Pauline Pluviaud
OM Pharma
Drug Safety Operations Manager
Pauline has over 12 years of experience in pharmacovigilance, clinical trials, post-marketing, project, and team management. A pharmacist by training, Pauline began her career in vaccines at Sanofi-Pasteur MSD. She then worked at pharmacovigilance service providers, such as UBC, where she gained expertise in case processing, safety database set-up and configurations, and data management. At OM Pharma, Pauline specializes in drug safety and was responsible for selecting and implementing a new global safety database and pharmacovigilance system.
Antonio Stassi
Recordati
R&D and Quality Application Manager
Antonio Stassi
Recordati
R&D and Quality Application Manager
Before joining Recordati in 2015, Antonio spent most of his career in service consulting and technology firms and has obtained ITIL v3 Expert and ITIL4 Managing Professional certifications. Currently, Antonio leads the R&D and Quality Application team, which is responsible for rolling out the Veeva Vault applications in regulatory, clinical, quality, and medcomms environments. As a team leader, he has experience in document data migration of more than 400,000 documents in production in all vault areas in scope.
Luca Manfro
Recordati
IT Project Manager, Global R&D Business Applications
Luca Manfro
Recordati
IT Project Manager, Global R&D Business Applications
Luca has over 20 years of experience in the IT industry and more than 10 years in the pharma industry. He has been involved in many IT implementation projects, especially in R&D, collaborating with different stakeholders to adopt new solutions which align with the company’s IT roadmap and business needs. Luca is enthusiastic about new technologies and digitalization and committed to bringing innovation by adopting new IT solutions.
Letizia Caccialupi
Sanofi CHC
Global Head of CHC Quality Systems & Excellence
Letizia Caccialupi
Sanofi CHC
Global Head of CHC Quality Systems & Excellence
Letizia is a chemist with wide-ranging experience in quality management and digitalization, with a strong production understanding and a process-oriented mindset. Some achievements of the past year include leading the implementation of Veeva Quality Docs in the CHC division within eight months from the project start and Veeva QMS (Change Control and Events, Investigations, and CAPA) within 11 months from the project start. In the past, Letizia played a key quality role in the implementation of Electronic Batch records in 2 API plants.
Sanofi CHC: Simplifying and Harmonizing Quality Processes Across the Enterprise
Tuesday 13:30 CEST
Innis Viviers
Sanofi
Head of Strategy and Operations, xEVMPD, IDMP and FMD
Innis Viviers
Sanofi
Head of Strategy and Operations, xEVMPD, IDMP and FMD
Innis has worked in the pharmaceutical industry for over 20 years, from data management and biostatistics to quality assurance, clinical research, and even agile development software. Since 2013 he has focused on structured data standards like xEVMPD and now mainly IDMP.
Yves Jacob
Sanofi
Country Regulatory Head France
Yves Jacob
Sanofi
Country Regulatory Head France
Yves is a pharmacist by training with more than 20 years of regulatory experience. In 2004 Yves joined Sanofi where he held various positions in the regulatory affairs department in cardiology and diabetes, including as leader of the regulatory team leader responsible for obtaining the first worldwide regulatory approvals of DuoPlavin, Lyxumia, and Zynquista. He also worked as R&D project director to initiate new Life Cycle Management (LCM) studies for Praluent. Three years ago, Yves was appointed as the country regulatory head for France.
Lewis Angell
Simbec-Orion
Associate Director, Clinical Operations
Lewis Angell
Simbec-Orion
Associate Director, Clinical Operations
Lewis is currently an associate director of clinical operations at Simbec-Orion, having worked through all levels of clinical operations. He is interested in how systems, when used effectively, can improve efficiency and reduce the burden of clinical trials for sites, sponsors, and patients.
Pavol Fucek
Sotio Biotech a.s.
Head of QA & PV
Pavol Fucek
Sotio Biotech a.s.
Head of QA & PV
Pavol holds a degree in medicine and has more than 18 years of experience in clinical trial planning and conduct, with extensive expertise in drug development. In 2014 he assumed his current position as head of quality assurance and pharmacovigilance at Sotio, a biotechnology company with a pipeline of oncology programs. Pavol enjoys the challenges of streamlining processes through technology and development.
Hemant Gawande
Syneos Health
Principal Clinical Programmer
Hemant Gawande
Syneos Health
Principal Clinical Programmer
Throughout his career, Hemant has helped several sponsors move from traditional clinical system platforms to newer SaaS cloud platforms. With a keen interest in the clinical research domain, Hemant has been able to explore multiple aspects of clinical trials and solutions with sponsors. Hemant is a regular contributor to the SCDM community and enjoys sharing insights about the future of data management.
Leonie Christianson
Syneos Health
Director, R&D Advisory
Leonie Christianson
Syneos Health
Director, R&D Advisory
Leonie has over 20 years of experience in various leadership and business transformation leadership roles in clinical data management and clinical operations. She has led global projects to convert paper CRFs to EDC, has implemented a clinical trial management system, and more recently led the implementation of Veeva Vault CDMS in a top 20 biopharmaceutical company. She has also led experimental projects to explore AI/ML opportunities in clinical data management.
Morad Tahani
UCB
IT Lead Regulatory
Morad Tahani
UCB
IT Lead Regulatory
Morad is an IT regulatory lead at UCB with over 25 years of experience across large biotechnologies, vaccines, and pharmaceutical companies. Morad has expertise in regulatory operations and IT, and he has led complex global transformation programs for regulatory, safety, and clinical departments. Currently, he is leading the implementation of the Regulatory Source Submissions Vault and defining the regulatory landscape strategy with different stakeholders, looking at automation opportunities to improve efficiency, quality, and time to delivery.
UCB: Improving End-to-end Regulatory Operations with a Platform Approach
Tuesday 17:00 CEST
Daniel Henley
VCTC
Co-Founder and Managing Director
Daniel Henley
VCTC
Co-Founder and Managing Director
Dan is passionate about moving clinical trials forward and finding ways to make it easier for people to participate in research. In 2005 Dan started his life sciences career as a project coordinator at a boutique regulatory service company. In 2007 Dan transitioned into a medical education role before finding his home in the CRO world. Since then, Dan has worked across most functions before stepping into leadership and board positions at a UK-based global CRO, where he managed a team of 200 people.
VCTC: Unlocking Site Productivity: Sponsors Hold the Key to Faster, Smoother Clinical Operations
Tuesday 17:00 CEST
Heather Howarth
VCTC
Principal Study Coordinator
Heather Howarth
VCTC
Principal Study Coordinator
Heather started her career in phase one trials, gaining experience in volunteer recruitment and project management. She then moved to VCTC to focus on project management of patient trials. Heather is passionate about increasing access and efficiency in clinical trials.
VCTC: Unlocking Site Productivity: Sponsors Hold the Key to Faster, Smoother Clinical Operations
Tuesday 17:00 CEST
Francesco Fiorentini
argenx
BIS Development Lead
Francesco Fiorentini
argenx
BIS Development Lead
Francesco is an IT R&D consulting professional with over 20 years of experience. He is skilled in change control, GxP, databases, management, and regulations.
Hans Jacobs
argenx
DDQ Vault Development Cloud Analyst
Hans Jacobs
argenx
DDQ Vault Development Cloud Analyst
Hans has extensive experience implementing transformative content and data management platforms in the life sciences. In roles at PwC, IBM, and Veeva, Hans has participated in the journey from paper-based and disconnected tools and processes towards more connected and shared operating models. As a development cloud analyst, Hans continues to push the transformation agenda by applying the R&D platform vision across the argenx development and quality areas.
Birjo Backasch
medac GmbH
Director Quality Assurance Systems
Birjo Backasch
medac GmbH
Director Quality Assurance Systems
Birjo studied biotechnology and has more than 15 years of experience in the pharmaceutical and biotech industry. After holding various positions in the quality organization of national and international companies, he has been with medac GmbH for more than seven years. As the director of quality assurance systems, he is responsible for QA processes deviation/CAPA, change control, qualification/validation, and document management. Since 2021, Birjo’s team has acted as the business owner for the medac group multi-year global program to transform and harmonize quality management systems through implementing Vault QualityDocs (incl. StationManager), Training, and QMS.
Brian Bialkowski
Veeva
Director, Product Management
Brian Bialkowski
Veeva
Director, Product Management
Brian has been with Veeva since 2017 and currently leads the Product team in Vault Clinical, responsible for Vault eTMF, Study Startup (SSU), and certain functionality that crosses the product suite.
Before Veeva, Brian spent three and a half years at Bioclinica, where he led product design and delivery for enterprise data warehouse, reporting, and analytics using EDC, RTSM, and CTMS data. He also led their RBM product.
Before that, Brian led Informa’s Medtrack product, which was a searchable database covering corporate, scientific, and financial data across the life science industry.
Andrea Grau
Veeva Systems
Solution Engineer, Clinical Operations
Andrea Grau
Veeva Systems
Solution Engineer, Clinical Operations
Andrea Grau is a Solution Engineer focusing on R&D Clinical in Europe. She has four years of experience within the Life Sciences R&D ecosystem. Before joining Veeva, she worked as a CRO within Clinical Operations, coordinating global Oncology and Rare diseases’ phase I-II studies. She holds a BSc in Biomedical Engineering and MSc in Industrial Management and Innovation from Pompeu Fabra University and Uppsala University, respectively.
Innovation Theater: Increase Speed and Improve TMF Quality with Automation and AI
Tuesday 16:30 CEST
Andrew Gebbie
Veeva Systems
Principal Solution Consultant, Clinical Data
Andrew Gebbie
Veeva Systems
Principal Solution Consultant, Clinical Data
Andrew has worked in the Clinical Trials Arena for more than 30 years in both Data Management and Clinical Operations as well as Clinical Trials Software. After graduating from Glasgow Caledonian University with a B.Sc. in Applied Biology, Andrew joined a small CRO in Scotland that was later acquired by PPD. Starting off in Data Management and then moving on to Database Building and Programming. The acquisition by PPD opened up new opportunities and this allowed Andrew to spend a few years as a CRA before moving back to Data Management in a Senior Management role. After 20 years with PPD, Andrew moved on to Solution Consulting and spent nine years at Medidata. Andrew joined the Clinical Solution Consulting group at Veeva in 2020.
End-to-End Digital Trials with Veeva
Tuesday 17:00 CEST
Innovation Theater: Eliminate Custom Functions with Vault EDC’s Rules Engine
Wednesday 12:30 CEST
Andy Han
Veeva Systems
Vice President Product Management, Vault Platform & Technology
Andy Han
Veeva Systems
Vice President Product Management, Vault Platform & Technology
Andy is the VP of Product Management for Vault Platform. Andy’s team is focused on delivering a robust platform for the rapid development of Vault Applications. He has more than 20 years of enterprise software experience and has held product positions at NextLabs, Siebel Systems, and Accenture.
Roadmap: Vault Platform
Wednesday 9:00 CEST
Roadmap: Vault Platform Replay
Wednesday 11:00 CEST
Innovations in Environment Management
Wednesday 13:00 CEST
Anna Kecinski
Veeva Systems
Senior Solution Consultant
Anna Kecinski
Veeva Systems
Senior Solution Consultant
Having worked for more than ten years in the Regulatory Affairs Industry, gaining experience in different companies and countries focusing on global Publishing, Anna has been a Solution Consultant with Veeva for the past three years.
Innovation Theater: Publishing with Submission Content Plans
Monday 17:30 CEST
Innovation Theater: Publishing with Submission Content Plans
Tuesday 13:00 CEST
Bernat Rocarols
Veeva Systems
Solution Consultant, Quality
Bernat Rocarols
Veeva Systems
Solution Consultant, Quality
Bernat is a Solution Consultant for Quality & Development Cloud at Veeva Systems, specialising in the European market. With a solid background as a Biomedical Engineer, Bernat possesses over six years of experience in the life sciences industry, working in diverse environments ranging from small-scale startups to large-scale organisations. Leveraging his technical expertise and industry knowledge, Bernat offers a unique perspective on harnessing digital tools to drive the digitalisation and efficient management of Quality Management Systems.
Innovation Theater: Modernizing and Accelerating Validation Management Processes (Repeats)
Monday 17:30 CEST
Innovation Theater: Modernizing and Accelerating Validation Management Processes
Tuesday 16:30 CEST
Bipin Patel
Veeva Systems
Senior Solution Consultant, Clinical Data
Bipin Patel
Veeva Systems
Senior Solution Consultant, Clinical Data
With a passion for problem-solving and a deep understanding of site engagement, Bipin is a seasoned Solution Consultant with 24+ years of experience delivering impactful solutions to clients across life sciences. He thrives on translating complex challenges into innovative and practical solutions in the context of cloud and platform-based clinical solutions.
Bárbara Cano
Veeva Systems
Senior Product Expert, Clinical Operations
Bárbara Cano
Veeva Systems
Senior Product Expert, Clinical Operations
As a Senior Product Expert, Bárbara is part of the ClinOps Product Management team focused on Product Communication and Product Adoption.
With more than 5+ years of R&D industry experience and dedicated focus on CROs & Clinical Trials she joined Veeva in 2016 as an R&D Consultant. After 2 years then moved into Customer Success Manager working on multiple projects, implementing and supporting customers globally on all of the ClinOps Vault Suite applications.
The Basics of Veeva SiteVault
Wednesday 12:30 CEST
Innovation Theater: Streamline Data Transfers with Vault Clinical Connections
Wednesday 13:30 CEST
David Kolosic
Veeva Systems
Senior Manager, Vault Safety
David Kolosic
Veeva Systems
Senior Manager, Vault Safety
David is the Senior Manager for Vault Safety at Veeva and has almost a decade of experience in multiple disciplines, including pharmacovigilance, quality management, regulatory information management, and business development. He has helped pharma companies transform organizations to become more efficient, collaborative, and successful with modern technologies. He holds a Bachelor of Science (BSc), Pharmaceutical Studies (Hons) and a Master of Science (MSc), Pharmaceutical Science and Management Studies from Kingston University, London, UK.
Innovation Theater: A Day in the Life of a QPPV Office
Tuesday 14:30 CEST
Innovation Theater: A Day in the Life of a Case Management Team
Wednesday 10:30 CEST
Customer Panel: Improving Safety Operations
Wednesday 11:00 CEST
Drew Garty
Veeva Systems
Chief Technology Officer, Vault CDMS
Drew Garty
Veeva Systems
Chief Technology Officer, Vault CDMS
Drew’s career in pharmaceutical technology spans over 20 years. It includes significant experience in eClinical system architecture, design, and development, as well as process design, solution validation, and international implementation and support. Drew joined Veeva in 2016 as vice president of product management and led the ground-up design of Veeva’s Vault EDC solution. In his current role as Chief Technology Officer at Vault CDMS, Drew shares and collaborates with customers, partners, and the industry to set the vision and direction of Veeva’s CDMS product.
Eldar Curovic
Veeva Systems
VP, Product Management, Vault RIM
Eldar Curovic
Veeva Systems
VP, Product Management, Vault RIM
As Vice President of Product Management for Regulatory, Eldar is responsible for the product teams for Registrations, Submissions, Submissions Archive, and Submissions Publishing. Eldar has over 18 years of experience in enterprise software delivering innovative and industry-leading technology solutions across the globe.
Roadmap: Vault RIM
Wednesday 9:00 CEST
Vault RIM Product Preview: Enhanced Usability and Automation
Wednesday 13:00 CEST
Eric Woolven
Veeva Systems
Senior Product Manager, SafetyDocs
Eric Woolven
Veeva Systems
Senior Product Manager, SafetyDocs
Eric is the Senior Product Manager for Vault SafetyDocs. Eric was previously a Product Manager on the Vault Safety team working on features across Vault Safety Management. The main areas he worked on in core Safety are follow-up, SDK, narratives, medical review timeline, distributions, and correspondence.
Francesca Massa
Veeva Systems
Senior Solution Consultant, Clinical Operations
Francesca Massa
Veeva Systems
Senior Solution Consultant, Clinical Operations
Francesca is a Senior Solution Consultant, she is involved in the sales process, and together with Strategy, she supports the Account Partners to bring industry and product expertise to customer conversations to help them view the right solution. Francesca has worked in the life science industry for the last eight years, always in a sales role with a strong focus on software.
She profoundly understands industry needs, requirements, and market trends.
Innovation Theater: Achieve Study Oversight with Vault CTMS
Tuesday 15:00 CEST
Innovation Theater: Pay Sites Faster with Vault Payments
Wednesday 12:30 CEST
Graham Gelwicks
Veeva Systems
Director of Product Management, Vault Platform
Graham Gelwicks
Veeva Systems
Director of Product Management, Vault Platform
Graham is the Director of Product Management at Veeva, responsible for the success of several areas of the Vault Platform, including reporting and workflows. Before joining Veeva in 2015, Graham was a management consultant at L.E.K. Consulting and an investor at Upfront Ventures. Graham earned an undergraduate degree from UC Berkeley in economics and business and a master’s degree in computer science from UIUC.
Innovation Theater: Multiple Record and Document Workflows
Tuesday 12:00 CEST
Vault Reporting & Dashboard Fundamentals and Roadmap
Tuesday 13:30 CEST
Innovation Theater: Advanced Vault Reporting and Dashboards
Tuesday 15:00 CEST
Graham O’Keeffe
Veeva Systems
General Manager, LearnGxP
Graham O’Keeffe
Veeva Systems
General Manager, LearnGxP
Graham has spent his entire career working in the life sciences in the quality space for companies including Pfizer, J&J, Merck, Baxter, Boston Scientific and now at Veeva Systems. As General Manager with LearnGxP, he is helping companies deliver engaging online compliance and regulatory training to ensure workforces remain focussed on product quality and customer safety.
Innovation Theater: Transforming GxP Refresher Training: A Modern Approach to Compliance
Wednesday 13:00 CEST
Iain Searle
Veeva Systems
Director, Training Strategy, Europe
Iain Searle
Veeva Systems
Director, Training Strategy, Europe
Iain is a Senior Learning, Quality Management and GCP professional with 25 years of experience in the pharmaceutical industry.
Iain has spent 17 years in training, quality and process roles for global CROs before moving to Veeva to take up the Director of Training Strategy Europe position.
Before specialising in Learning & Quality Management, he worked as a Clinical Research Scientist, CRA, Clinical Project Manager and Clinical Team Manager.
Innovation Theater: Transforming 21st Century Training with Mixed Reality (Repeats)
Tuesday 12:00 CEST
Innovation Theater: Transforming 21st Century Training with Mixed Reality
Tuesday 13:00 CEST
James Wade
Veeva Systems
Director Product Management, Link Clinical
James Wade
Veeva Systems
Director Product Management, Link Clinical
James is the Director of Product Management and Team Link, Link Clinical. He is responsible for the Link Clinical products: TrialBase and SiteBase. James has worked in the pharmaceutical & healthcare sector since 2010. He has combined medical science and in-depth industry knowledge with a technical skillset in data and advanced analytics. Over the last seven years, he has applied this experience to deliver innovative data and analytics products designed to solve key industry challenges.
John Lawrie
Veeva Systems
Vice President, Vault Safety
John Lawrie
Veeva Systems
Vice President, Vault Safety
John Lawrie has over 20 years of experience in the pharmaceutical industry. He is currently Vice President of Vault Safety. In this role, he’s responsible for growing our Safety market success and setting the direction, strategy and growth plans for our suites of applications. He’s been heavily involved on the Safety side for more than 18 months
Before joining Veeva, John led the consulting group at Octagon Research Solutions (now Accenture), which specialised in assisting clients with planning and developing CDISC-based data and regulatory submission capabilities to achieve regulatory compliance while maximising operating efficiencies. He has extensive experience with implementing globally-deployed systems. John has also worked for Computer Sciences Corporation, where he led business analysis, process design, organizational change and project management activities.
John graduated from Bucknell University with a bachelor of science degree in mechanical engineering.
Jon Carter
Veeva Systems
Senior Product Manager
Jon Carter
Veeva Systems
Senior Product Manager
Jon has had the privilege of being a part of the industry for 17 years, witnessing the evolution of clinical trials from traditional paper-based processes to the digital world we live in. His journey began as a database programmer, and over time, he transitioned into product management, specialising in EDC and eSource solutions. Joining Veeva was a significant milestone for him, as it allowed him to continue his professional growth in the MyVeeva for Patients team, focusing on ePRO and eClinRO advancements.
With a solid foundation in technical expertise, Jon has gained a comprehensive understanding of the complex requirements of clinical trials. Jon’s current role at Veeva revolves around enhancing patient-centricity through ePRO and eClinRO. He is passionate about revolutionising the patient experience within clinical trials and leveraging innovative approaches to drive meaningful change.
Innovation Theater: ePRO & ClinRO Showcase
Tuesday 12:30 CEST
Roadmap: Veeva ePRO & ClinRO
Wednesday 9:00 CEST
Justin Lavimodiere
Veeva Systems
Senior Director, Vault LIMS
Justin Lavimodiere
Veeva Systems
Senior Director, Vault LIMS
Justin is a member of Vault Quality Strategy, focused on the unification of quality assurance and quality control within Vault LIMS. As a laboratory informatics professional, he brings over 16 years of experience partnering with manufacturing and quality organizations to optimize efficiency, accessibility, quality, and compliance through digital transformation.
Accenture and Veeva: Optimizing End-to-End Quality with Unified QA and QC
Wednesday 11:00 CEST
Katerina Boussuge
Veeva Systems
Solution Engineer, Regulatory
Katerina Boussuge
Veeva Systems
Solution Engineer, Regulatory
Katerina has been working in the life science industry since 2014. Starting as a Regulatory Affairs Project Manager leading cross-functional R&D teams and regulatory projects for diverse clients in the EU. She joined Veeva in August 2022 as part of Veeva’s Solution Consulting team, supporting the Account Partners in the sales process. Coming from the industry and thus understanding the pains and the needs, Katerina likes to demonstrate the values that Vault RIM can bring to Veeva customers.
Kathia Frendi
Veeva Systems
Solution Consultant, Vault Safety Suite
Kathia Frendi
Veeva Systems
Solution Consultant, Vault Safety Suite
Kathia is a Solution Consultant for Vault Safety since 2021 and joined the team as the first Safety SC in Europe. Kathia has worked in the life science industry for several years, particularly in pharmacovigilance, since 2013. Her main activities consisted of managing ISCR processing in safety databases as a data manager in CROs and laboratories, mainly in the oncological therapeutic area.
Kim Brownrigg
Veeva Systems
Practice Manager, Regulatory Business Consulting
Kim Brownrigg
Veeva Systems
Practice Manager, Regulatory Business Consulting
Kim joined Veeva in 2023 to lead the EU Regulatory Business Consulting team to help maximize business value from Vault products. Prior to joining Veeva Kim was at Accenture for ten years and for the last five of these led the Regulatory Practice in Europe overseeing projects, leading business development and driving the global strategy on digital transformation within Regulatory. Prior to Accenture Kim also did five years in industry focusing on roles in CMC and labelling.
Bayer Consumer Health: Partnering with Veeva Business Consulting to Drive Value Realization
Wednesday 11:00 CEST
Krisztián Csobályka
Veeva Systems
Principal Consultant, R&D Post-Implementation Services
Krisztián Csobályka
Veeva Systems
Principal Consultant, R&D Post-Implementation Services
Krisztián is a Vault Platform and Vault Quality expert working on Enterprise Post-Implementation Projects (EAM), helping customers define their Change Management, Environment Management, and Release Management processes using Agile and ITIL principles.
As a driver of Continuous Service Improvement (CSI), he leverages the synergy he gains from working with various customers simultaneously by providing guidance, best practices, and solutions to fulfil our client’s changing business needs.
Lucas Alcover
Veeva Systems
Consultant, Vault RIM
Lucas Alcover
Veeva Systems
Consultant, Vault RIM
Lucas is an Industrial Engineer with a master’s in Management Engineering who started in the life sciences industry five years ago, building expertise in digital solution implementations for Veeva Vault Quality, RIM and Vault Connections. Today, his main responsibilities in Veeva cover cross-Vault activities for customers and internal development across the whole Development Cloud.
Idorsia: Modernizing Operations with a RIM Gap Analysis
Tuesday 15:30 CEST
Driving Enterprise Efficiency with Vault Connections
Tuesday 17:00 CEST
Marie-Claire Flavin
Veeva Systems
Director Customer Success
Marie-Claire Flavin
Veeva Systems
Director Customer Success
Marie-Claire manages Customer Success for sites in the European region. She came to Veeva after ten years working within Oncology in the NHS, most recently in the Coordination Centre of the National Institute of Health and Social Care Research as the first Research Delivery Digital Lead. Marie-Claire is enthusiastic about supporting sites in using SiteVault to transform their research.
Marius Mortensen
Veeva Systems
VP Product Management, Vault Safety Suite
Marius Mortensen
Veeva Systems
VP Product Management, Vault Safety Suite
Marius is the VP of Product Management for Vault Safety. He has built world-class products and platforms across various industries for 20 years. Marius joined Veeva in 2015, working on the Vault Platform and has been focused on helping Life Sciences organizations innovate and solve complex problems ever since. In 2017 his attention turned to Pharmacovigilance. Before Veeva, Marius worked at D+H (now Finastra), a top 20 FinTech, building their enterprise lending compliance platform and designing their next-generation products.
Innovation Theater: A Day in the Life of an Adverse Event in the Veeva Development Cloud
Tuesday 12:30 CEST
Roadmap: Vault Safety Suite
Wednesday 9:00 CEST
Mark Arnold
Veeva Systems
Director of Product Management, Vault API & SDK
Mark Arnold
Veeva Systems
Director of Product Management, Vault API & SDK
Mark is responsible for helping to enrich the developer experience for Veeva Vault. He takes feedback from customers and internal resources and uses industry best practices. Mark manages the world-class integration features for the Vault Platform.
Innovation Theater: Vault Mobile – How to Better Support Business and Users
Tuesday 13:00 CEST
System Integration Best Practices
Tuesday 15:30 CEST
Martino Tomizioli
Veeva Systems
Senior Solution Consultant, Quality
Martino Tomizioli
Veeva Systems
Senior Solution Consultant, Quality
Ph.D. from the University of Grenoble (France), Martino is a Senior Solution Consultant. He has extensive experience in pre-sales and sales engineering for cloud-based solutions SaaS. Martino’s expertise covers working with both SMBs and enterprise accounts within the Pharmaceutical and Medtech industry across multiple countries and languages in Europe including English, Italian, French, and Spanish.
Innovation Theater: Veeva Development Cloud to Commercial Cloud Connections
Monday 17:30 CEST
Innovation Theater: Veeva Development Cloud to Commercial Cloud Connections
Tuesday 16:30 CEST
Mercedes Santoro
Veeva Systems
Solution Consultant, Regulatory
Mercedes Santoro
Veeva Systems
Solution Consultant, Regulatory
Bachelor in Biotechnology. Mercedes has ten years of experience in the Pharmaceutical Industry, working in Regulatory, Clinical, Safety and Quality to gain a strong knowledge of the whole business. As a Solution Consultant, she works closely with potential customers to discover and understand their needs and pain points and demonstrate how Vault RIM can bring value to their business and meet those needs.
Natalie Townsend
Veeva Systems
VP Strategy, Veeva RTSM
Natalie Townsend
Veeva Systems
VP Strategy, Veeva RTSM
With over 19 years of industry experience spanning technical support, project management, sales and strategy roles, Natalie has designed and delivered RTSM solutions for an extensive range of studies and customers. She has a passion for driving innovation and collaborating with industry peers to deliver better clinical trial experiences for all stakeholders, especially sites and patients.
Veeva RTSM: Delivering Better Product and Better Services
Tuesday 13:30 CEST
End-to-End Digital Trials with Veeva
Tuesday 17:00 CEST
Roadmap: Veeva RTSM
Wednesday 9:00 CEST
Innovation Theater: Integrating EDC & RTSM
Wednesday 10:30 CEST
Nima Shah
Veeva Systems
VP, Product Management, Vault Quality & Manufacturing
Nima Shah
Veeva Systems
VP, Product Management, Vault Quality & Manufacturing
Nima Shah is the VP of Product Management for Quality & Manufacturing Products at Veeva. She has over 20 years of experience building and scaling product and engineering teams for sophisticated and high performing direct-to-consumer and enterprise cloud software systems. At Veeva, she is globally responsible for the design, development and success of the Vault Quality Suite and family of applications that span across Quality, Manufacturing, Digital QC Labs and Learning Management Products. Nima holds a BS and MS in Electrical Engineering.
Nina Ricciardelli
Veeva Systems
Director, Vault Validation Management
Nina Ricciardelli
Veeva Systems
Director, Vault Validation Management
Nina is the Director of Vault Validation Management at Veeva. She has built a successful career in the life sciences industry, focusing more than five years on helping organizations digitally transform their validation processes. She serves as a strategy lead, focusing on customer success and leveraging her extensive industry knowledge to help customers adapt to evolving industry guidelines and regulatory landscapes.
Innovation Theater: Modernizing and Accelerating Validation Management Processes (Repeats)
Monday 17:30 CEST
Innovation Theater: Modernizing and Accelerating Validation Management Processes
Tuesday 16:30 CEST
Núria Bernaus
Veeva Systems
Solution Consultant
Núria Bernaus
Veeva Systems
Solution Consultant
In Nuria’s role as a Solution Consultant, she engages with customers to understand their specific needs and requirements and tailor demos to customers so they can scale and streamline their RIM processes, giving them technical and functional insights into how the solution can help them.
Innovation Theater: End-to-end RIM
Monday 17:00 CEST
Innovation Theater: End-to-end RIM
Tuesday 14:30 CEST
Oliver Cooksey
Veeva Systems
Solution Consultant, Regulatory
Oliver Cooksey
Veeva Systems
Solution Consultant, Regulatory
Oliver is a Solution Consultant for Vault RIM since 2020. He graduated from University with a degree in Biomedical Sciences, during which he spent a year working with a Veeva Customer. Oliver has a passion for understanding and improving patient outcomes in healthcare.
Innovation Theater: 23R1 Vault RIM Features
Tuesday 16:30 CEST
Innovation Theater: Global Content Plans
Wednesday 12:30 CEST
Paul Macdonald
Veeva Systems
Senior Director, Strategy, Vault CDMS & Team Lead EU
Paul Macdonald
Veeva Systems
Senior Director, Strategy, Vault CDMS & Team Lead EU
Paul is a Senior Director for Vault CDMS, responsible for strategy and direction in data management. With more than 25 years of experience working in life science at pharma, CRO and technology organisations, he brings a strong operational focus in relation to eClinical technology for data management and clinical operations that stretches from EDC through CTMS to risk-based monitoring.
Innovation Theater: Integrating EDC & RTSM
Wednesday 10:30 CEST
Innovation Theater: Eliminate Custom Functions with Vault EDC’s Rules Engine
Wednesday 12:30 CEST
Raymond Letulle
Veeva Systems
SVP Products, Vault CDMS
Raymond Letulle
Veeva Systems
SVP Products, Vault CDMS
Raymond Letulle leads the development of Veeva Vault CDMS, helping customers improve data quality and speed to cut the cost and complexity in clinical trials.
Raymond brings over 25 years of experience to Veeva delivering enterprise and cloud-based software. He comes to Veeva from Medrio, Inc., where he spent the past several years as chief operating officer and head of product, owning the product roadmap and delivery of their cloud-based eClinical EDC and eSource products. Through his many years of experience, Raymond has developing firsthand knowledge of the best practices and challenges faced by product, engineering, marketing, and sales in delivering technology products to market.
Raymond holds a bachelor of arts degree in economics from Rice University.
Rich Merrick
Veeva Systems
Senior Director, Product Management, Vault RIM
Rich Merrick
Veeva Systems
Senior Director, Product Management, Vault RIM
Rich has spent over twenty years partnering with life sciences companies to implement and innovate software solutions that meet the evolving standards within regulatory and technology. Rich has been involved with regulatory information management systems since 2000, supporting, implementing, and designing solutions to streamline the submission and registration management process. Currently, Rich is responsible for leading the design and development of Vault Submissions, Submissions Archive, and Submissions Publishing.
Rob Arnold
Veeva Systems
Solution Consultant, Clinical Operations
Rob Arnold
Veeva Systems
Solution Consultant, Clinical Operations
Based in Southern California, Rob is a Solution Consultant on the Veeva Clinical Operations team.He specialises in pre-sale demos for our Vault Clinical Operations Suite, which includes eTMF, CTMS, Payments, Study Startup, and Study Training. He is also team’s Solution Lead for Vault Study Training.
Samuela Bellini
Veeva Systems
Senior Practice Director, Vault Safety – EU
Samuela Bellini
Veeva Systems
Senior Practice Director, Vault Safety – EU
Samuela is the Senior Practice Director for Vault Safety – EU and has 15 years of experience in technology consulting helping the Life Science industry in digital transformation. After more than 10 years of implementing Multichannel CRM in Pharmaceutical companies across the globe, she is now leading the Veeva EU Professional Services team responsible for implementing Vault Safety, providing an innovative database, submissions and reporting capabilities to the Pharmacovigilance department.
Shad Ayoub
Veeva Systems
Senior Director, Study Training
Shad Ayoub
Veeva Systems
Senior Director, Study Training
With over 15 years in the pharmaceutical services industry and over 20 years of software development experience, Shad has a strong foundation for delivering real value to Veeva’s clients and partners. Shad currently leads Veeva’s strategy for Vault Study Training, a recently announced application that brings together research sites, CROs, and sponsors into a single platform for end-to-end clinical study training.
Sid Mohamoodally
Veeva Systems
Senior Director, Strategy, Vault CDMS
Sid Mohamoodally
Veeva Systems
Senior Director, Strategy, Vault CDMS
Sid has been in the industry for 29 years with experience as a leader within the Clinical Research and Healthcare technology industry. His experience has been defining and implementing technology strategies globally and growing operational teams to support clinical trial delivery in Data Management and Bistatistics. Sid offers extensive cross-functional and direct experience in all trial phases delivering high-quality customer and business goals in the large Pharmaceutical, Biotech and CROs business segments. Most recently Sid has been focused on growing Vault CDMS in the Enterprise CRO sector at Veeva.
Steve Simmerman
Veeva Systems
General Manager, Veeva RTSM
Steve Simmerman
Veeva Systems
General Manager, Veeva RTSM
Steve has over 22 years of life sciences experience spanning everything from Clinical to Commercial. A Veeva veteran of over 11 years, Steve knows what it takes to make customers successful with Veeva products. As General Manager for Veeva RTSM, Steve focuses on bringing the Veeva values to the Randomization and Trail Supply Management space by delivering a better product and better services to this critical area.
Veeva RTSM: Delivering Better Product and Better Services
Tuesday 13:30 CEST
Roadmap: Veeva RTSM
Wednesday 9:00 CEST
Tim Davis
Veeva Systems
VP Strategy, MyVeeva for Patients
Tim Davis
Veeva Systems
VP Strategy, MyVeeva for Patients
Tim Davis has over 25 years of experience working in the Life Sciences industry from a pharmaceutical company, CRO, and technology vendor perspective.
Most notably, he was the Founder & CEO of Exco InTouch Ltd, a patient engagement and eCOA mobile application provider, which he scaled through to a successful trade sale and exit in 2016.
Tim is currently Vice President of Strategy at Veeva Systems. His primary focus is on the strategic development of MyVeeva for Patients, a patient-facing application suite.
End-to-End Digital Trials with Veeva
Tuesday 17:00 CEST
Roadmap: Veeva ePRO & ClinRO
Wednesday 9:00 CEST
Tom Dekker
Veeva Systems
VP Product Management, Vault Clinical Operations
Tom Dekker
Veeva Systems
VP Product Management, Vault Clinical Operations
As VP of product management for clinical operations, Tom leads a team responsible for the Vault eTMF, SSU, CTMS, and Vault Payments products. He has over ten years of experience as an eClinical developer and product manager. Prior to working for Veeva, he worked on eClinical solutions for Medrio, TrialWorks, Parexel, and Quintiles. He shares the belief that great products are built by listening to the customer and putting them first.
Werner Engelbrecht
Veeva Systems
Senior Director Strategy, Vault Clinical Operations
Werner Engelbrecht
Veeva Systems
Senior Director Strategy, Vault Clinical Operations
Werner has a medical, legal and IT background and more than 23 year of experience in the pharmaceutical industry in various roles and leadership levels with a 360-degree knowledge from early-stage drug development to post-approval life-cycle management
Previous roles include Investigator, CRA&Project Management in Pharma, Vaccine Accessor at the Austrian Regulatory Authority and Enterprise Account Management in the CRO industry.
Entrepreneur for start-ups in the health care and IT area.
VCTC: Unlocking Site Productivity: Sponsors Hold the Key to Faster, Smoother Clinical Operations
Tuesday 17:00 CEST