SVP, Head of Global Regulatory Affairs and R&D Quality
Dr. Jacques Mascaro
SVP, Head of Global Regulatory Affairs and R&D Quality
Pharmacist and Biologist, with a Doctorate in the field of Lipoproteins, Post-Doctorate in Superior Specialized Studies in Clinical Pharmacy, and MBA from the Open University Business School. With Hospital and Industry experience he had leadership positions in Regulatory Affairs, Quality-Compliance, Clinical R&D, Pharmacovigilance, Manufacturing-Supply Chain with Dupont-Merck, Collagen Corporation, H. Lundbeck A/S, Johnson & Johnson, F. Hoffmann-La Roche, and Elan working in EU and US. He joined Merck KGaA in 2012 as SVP Global RA-R&D Quality, acting Head of Global Clinical Development between 2014 and 2015 during R&D restructuring. He drove the transformation of Regulatory and Quality focusing on future-oriented solutions. He contributed at Trade Associations and DIA in Management and Board positions.
Adrian is a PhD scientist with over 25 years’ experience in Pharma Tech industry. Most recently Adrian’s focus has been to simplify the Tech experience for Clinical, Medical and Regulatory staff at GSK. A key strategy has been the agile, GCP deployment of cloud-based platforms to replace a portfolio of aged and discrete legacy systems.
As president of Veeva Europe, Chris is responsible for growing the business in the region.
A 27-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 partner with PwC in 2001. Chris went on to run both European and US (West Coast) life sciences business 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.
Rik is a senior executive with 20+ years of experience in both Management Consulting and Cloud Software in the Life Sciences / Pharmaceutical sector. His experience has been built in assisting clients through complex transformation programs across the Life Sciences value chain for most of the world’s largest companies. Rik is a recognized thought leader in the Life Sciences industry with deep expertise in architecting, launching and implementing innovative and industry-leading strategies and solutions.
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.
Mike Stroud is a Hospital Consultant Physician who is perhaps best known for his record-breaking expeditions with Sir Ranulph Fiennes. He is also an author, motivational speaker and world authority on expedition medicine, human endurance and the benefits of healthy lifestyles.
Mike initially qualified as a doctor in London in 1979 and then spent ten years in a variety of hospital posts interspersed with far-reaching expeditions and travel. In 1990, he entered full-time research on endurance, nutrition and survival under extreme conditions, working at both the RAF Institute of Aviation Medicine and then the Army Personnel Research Establishment. He later became the Chief Scientist at the UK Centre for Human Sciences. In 1995, he returned to hospital medicine and university work and in 1998 was appointed as a Senior Lecturer in Medicine and Nutrition, and Consultant Gastroenterologist at Southampton University Hospitals. In 2017 he was made Professor of Clinical Nutrition and he also holds many advisory roles in UK Healthcare particularly leading the efforts of the National Institute of Health & Clinical Excellence (NICE) to ensure that ‘optimal nutrition and hydration lie at the heart of ‘Quality Care’. His research is cited globally.
Mike is the author of two books, ‘Shadows on The Wasteland’ – documenting his unsupported foot crossing of Antarctica and ‘Survival of The Fittest’ which examines the relationship between nutrition, exercise, health and peak performance. He has presented his own BBC1 series, ‘The Challenge’ and was the endurance and medical expert on all three series of BBC TV’s, ‘Are You Tough Enough for the SAS’.
Andrew leads our work in Health Experiences and works with clients across the Health ecosystem ranging from life sciences companies, charities, health providers and HealthTech startups. Andrew has been in Accenture Interactive for since 2010 and collaborates across Accenture to ensure his team can innovate to change the way the world works and lives.
Following completion of her degree in Biomedical Science at the University of Newcastle, Australia Debbie had her first introduction to Clinical Research in 2002 with a collaborative research group conducting breast cancer research trials. Following her time with the collaborative group, Debbie gained experience in a Contract Research Organisation and joined AstraZeneca in 2009 as a Clinical Project Manager. From 2012s she supported the Asia, Middle East and Africa region in Site Management and Monitoring as a Business Strategy and Planning Director where she provided business and strategic support across local, regional and global areas of the organisation, driving one organisational mindset and leading discussions and next level thought processes to drive the AZ business forward With over 15 years of Clinical Trial experience Debbie is an advocate and champion of efficient and effective processes to deliver clinical trials to time, quality and cost. Debbie is a systems expert, who has keen respect and knowledge to connect stakeholders, customers and self to systems in support of business objectives and optimal performance standards.
VP, Corporate Quality – Head Process & Knowledge Management
Bayer Healthcare A/G
VP, Corporate Quality – Head Process & Knowledge Management
Heike Roeder in her position as Head of Process and Knowledge Management within Corporate Quality at Bayer is responsible to define corporate Quality Standards reflecting the newest stage of worldwide regulatory requirements and innovative industry trends.
She is leading an industry-wide discussion/transformation from classical documentation-based quality management towards integrated digital solutions. One of her key project at Bayer is the seamless integration of quality processes into a digital end-to-end process landscape.
Heike brings in a wealth experience from 20 years in the Pharma Industry, in various business areas, such as commercial production, supply chain, clinical trial supply, learning and process management, and quality management.
She graduated from the University of Düsseldorf (Germany) with a degree in Pharmacy and is certified as Lean Sigma Green Belt and as Change Coach.
Lianne has been working at BMS for 12 years, where she has had many roles within Regulatory (i.e., Regulatory Manager in Austria (2006-2010), Regulatory Manager in Sweden (2011 for 9 months on a Tour of Duty), Regulatory Manager in UK (2012 for 4 months on a Tour of Duty), Regulatory Manager, Distributor Markets Europe – responsible for Croatia, Iceland, Serbia and Slovenia (2012 to 2014). Lianne has been in her current role of Head of Regulatory in Austria since September 2014. Additionally, she is involved in other horizontal projects at BMS, e.g. Change Agent, trainer and CEL for the implementation of the Veeva Database.
James is a Regulatory Operations Professional with 18 years’ experience in the industry, including 9 years at a major innovator as well as stints in outsourcing, consulting, generic pharma and now nuclear medicine.
James has extensive experience of system and process design, migration, training, and system ownership for a full Veeva Vault RIM implementation (Registrations, Submissions and Submissions Archive). An Expert in eCTD/NeeS Submission Publishing and Submissions Management in all global regions, as well as recruiting, managing and motivating Regulatory Operations teams as both first and second-level line manager.
Wide experience setting up Submissions Publishing organisations, both on and offshore, in-house and outsourced, as well as designing e-Submissions processes and tools and rolling out use of Document Management systems – all with reference to Agency guidelines and Industry Best Practice.
Astrid holds a degree in biology from the University of Louvain-la-Neuve (Belgium). She joined GSK Vaccines in 2006 and handled several roles in clinical operations. Since 2013, she oversees the management of the Trial Master File at GSK Vaccines (owning the process, the system and the operations). Recently, Astrid took the lead on the implementation of Veeva TMF across the 3 business units of GSK.
She lives in Belgium, plays hockey, enjoys hiking, skiing, and spending time with her 3 kids.
I hold a degree in computer sciences from the University of Nantes (France). After having worked in France and Belgium in different companies I joined the Pharmaceutical world in 2002. I have been working for 6 years in UCB as TECH Project manager on several document management projects. I then moved to GSK Vaccines in 2008 in a similar role. I also worked on several document management projects and on big integration/migration projects in the context of the Novartis deal. I moved in clinical operations department end 2016 as TMF Global Business System Owner. Recently, I took the lead on the configuration and rollout of the Veeva TMF across the 3 business units of GSK. I’m also the Enterprise business system owner for this new system.
Jacintha has over 15 years of extensive life sciences experience in various quality roles. She is responsible for implementing and maintaining Horizon’s company-wide cross-functional quality systems to ensure compliance to requirements throughout the organization. Prior to Horizon, Jacintha worked in a number of Quality positions that included facilitating all regulatory and customer audits to ensure GMP certification, and drafting, negotiating, and closing quality agreements with API suppliers.
Simone holds a degree in biology from the University of Freiburg, Germany. She has over 10 years of consulting experience in pharmaceutical R&D, strategy development, process optimization and restructuring programs as well as system implementations.
In 2011, Simone joined Actelion Pharmaceuticals as eClinical Program & Change Manager. She transferred to Idorsia Pharmaceuticals when the company was founded as spin-off during the acquisition of Actelion by a Johnson & Johnson in June 2017.
Simone is responsible for the implementation and support of Idorsia’s Clinical & Quality Systems landscape and is System Owner of Veeva Vault.
She lives in Basel, Switzerland and enjoys adventures related to scuba-diving, paragliding, and mountaineering.
Experience across multiple functions in the Beverage and Healthcare industries working with Pepsi, Coca Cola and Johnson & Johnson. Initially an Industrial Biochemist now focused on the global J&J Enterprise Quality Systems Strategy. Working globally across the Pharma, Consumer and Medical Device segments to deliver a focused road-map towards reducing Quality System complexity.
As Senior Director Digital Business Platforms, Mika is responsible for the overall strategy and the shaping of the digital journey for LEO Pharma through the use of digital platforms. With more than 25 years of experience in IT and the past 13 years as an IT executive within the life sciences, Mika has a broad understanding of the conditions that drive the life sciences industry and is passionate about enabling business transformations through IT and digital platforms.
More than 16 years of business experience within IT programs/projects with the role as Business Consultant, Business Development Manager, Life Science Business Advisor and now Business Relationship Manager at LEO Pharma, where he has worked since January 2017. Main experience & expertise within the Life Science industry (12 years) with core competencies in IT strategy & process consulting, relationship management, and execution from business idea to concept/solution.
Rune Bergendorff has worked for several of Europe’s Top 20 Pharmaceutical companies, providing consultancy, project management and advicory. Rune’s specialties are within regulatory affairs transformation, moving from documents to structured data, from silo application landscapes to unified platforms by introducing the next waves of RIMS, EDMS solutions etc. Moreover he has profound experience with setting Regulatory IT Strategies (EUTelematics, PDUFA), digitalization of the pharmaceutical industry, hereunder robotics and process automation (RPA), and standardization of data elements describing products and substances (IDMP, xEVMPD, FMD etc.). He heads up NNITs Life Sciences Advisory unit representing Pharmaceutical Production, Clinical, Laboratory and Regulatory Affairs.
Gaurav has more than 15 years working experience in strategy development and execution of IT outsourcing and transformation within the life sciences industry. Gaurav’s strengths are in developing services, building global units and delivery models with cost-effective strategies; streamlining operations and optimizing processes to deliver user-centric support services. His primary life sciences industry experience is within R&D, regulatory, medical devices, manufacturing and supply chain.
Associate Director, Regulatory Information Management
Associate Director, Regulatory Information Management
A skilled regulatory affairs systems and process manager with over fifteen years’ experience in the life sciences and pharmaceutical sector, Segren has contributed to several successful regulatory compliance programmes and RIM system implementations. Segren currently leads the way for Norgine in ensuring its systems and processes are aligned to achieve RIM and IDMP compliance. Her team have undertaken a transformative project to achieve unified and progressive RIM for Norgine and implemented a new system, now being successfully embedded across the global organisation. Having managed this process from inception, Segren can share her insight into leveraging RIM to transform the Regulatory Affairs business.
Jade has 15 years’ experience of developing relationships in a B2B environment, from SME’s to global organisations of over 110,000 employees. Previously to working at Norgine, Jade was responsible for consulting with Senior Directors and CEO’s to implement value adding solutions, driving change and improving employee engagement, enabling measures for return on investment (ROI) to be mapped directly to the realisation of business goals and corporate growth. She now leads the RA Partner Services Team at Norgine – a new team established to strengthen its service provider relationships, enhance performance and identify opportunities for growth.
Sophie is a pharma R&D management consultant with experience that covers Quality topics within Development. Sophie is part of the PwC EU Pharma R&D team and focuses on the delivery of business transformation projects across R&D, with a focus on process design. Examples of projects include QMS assessments, process simplification and knowledge management development.
Olivier has 15 years of experience in the Pharmaceutical Industry, having held various position in various functional areas (Clinical, Quality & Risk, Regulatory). He has mainly held position as business project manager. In 2016, he joined the project of Vault Quality Docs implementation as Process Data Owner and since the go-live is working on the strategies to enhance Quality docs at UCB. Since then, Olivier is also PDO to Quality Management System and Learning Management System.
Mark Morris is Head Of Regulatory Knowledge Management at UCB, He has 15 years’ experience in Regulatory Operations. His areas of interest and specialization include Content Management, Regulatory Data/Analytics and Delivery of Operational Services.
Michel Van Nyvel (Bachelor degree in Information Technology) with 17 years’ experience in the Pharmaceutical Industry has had several positions in Data Management, Quality Management and Quality Assurance within UCB BioPharma. He has worked on the implementation of the different generations of eDMS.
He provides expertise and support to the different business entities about controlled documents and reporting. Member of the UCB implementation team of Vault Quality Docs, he led the validation part. The Project kicked off 02nd February 2016 and involved migrating 170 000 documents from Documentum, configuring the system, UAT and training of 3000 users by the first go live on 06 February 2017.
His role today is Digital Quality Partner supporting QualityDocs and Reporting.
The Vault Quality Docs solution at UCB contains documentation for 230 products relating to governance and procedures, analytical methods, specifications, stability documents, analytical and process documentation, master batch records, validation documents, quality management, training materials.
Paul is director of Valiance’s Dublin Ireland office. He currently oversees many of the Veeva migration efforts for Europe. He has extensive experience in Data Warehousing in Pharma and the Financial marketplaces. Prior to joining Valiance 2.5 years ago, he was in and managed a team of people at ICON CRO in the area of data management over a period of over 8 years.
Robert Gaertner is director of strategy for quality at Veeva in Europe. With more than 20 years of experience in the life sciences industry, he has a deep understanding of processes and systems in GxP-related areas. After starting his industry career at Fresenius Kabi, Robert has led various large programs in implementing quality-related systems, including eDMS, eQMS, and LIMS at different customers in pharma, biotech and medical devices. As a subject-matter expert and industry consultant, Robert has worked for leading companies such as PwC Consulting, IBM, Lodestone, and Infosys. Robert is a member of ISPE and the German Society for Good Research Practice.
Paul leads Veeva’s strategy team for the Vault product in the regulatory area. A technologist and business development professional, he has spent the past 23 years in the life sciences industry, following eight years as a software engineer. Previous roles have included leading the product management function in CSC’s Life Sciences Software Solutions Group. Prior to this, for 14 years he focused on product development, product support, professional services and business development associated with CSC’s Life Sciences solutions, heading up the European Life Sciences organisation during its transition from FCG Inc. into CSC.
Charles is leading a team of Vault and clinical experts who are delivering eTMF, CTMS and SSU applications to Veeva customers. Prior to Veeva, Charles held similar positions at other life science software vendors, which gives him a great understanding of the keys to successful software implementation in regulated environments.
Michael is responsible for R&D value engineering at Veeva where he works with customers to determine the potential and realized value of the Vault applications. Mike comes to Veeva with more than 15 years of operational experience working in both pharma and CROs.
Sandeep is responsible for Vault Quality products at Veeva. He has more than 12 years of experience in designing and managing enterprise software products for highly regulated industries. He previously led product teams at Deloitte, MobileIron and NextLabs. Sandeep holds a master’s degree in computer science from the University of California at Davis, where he was also a Regents Scholar.
Tom Dekker 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. Tom is a native to the San Francisco Bay Area. He currently lives in San Ramon with his wife Meagan and children Garrett (10), and Claire (7). Tom enjoys coaching his children’s sports, and bike rides up the Iron Horse Trail. While his skills aren’t what they used to be, he enjoys playing basketball with friends and five brothers. Tom is proud of working in an industry that helps to speed the development of new medicine and improving all our lives.
Joby George is a Senior Product Manager responsible for the Vault Training product.
Prior to joining Veeva, Joby spent 14 years at Sparta Systems designing and delivering regulatory and compliance solutions for the Life Sciences market.
Andy Han is responsible for Vault Tools and the Vault Developer Platform. His team is focused on delivering a robust platform for rapid development of Vault Applications and easy-to-use tools to streamline management of Enterprise Vault deployments. Andy has over 20 years or enterprise software experience and has held product positions at NextLabs, Siebel Systems, and Accenture.
As VP of product management for clinical operations, Steve is responsible for the Vault eTMF, CTMS and Study Startup product teams. He is also responsible for SiteVault and the Veeva Clinical Network.
Steve has been working in content management for the life sciences industry for 15 years. For the last six years Steve has helped build the Vault platform along with many of the applications built on top of it.
Prior to Veeva, Steve worked with the IBM Software Group and PricewaterhouseCoopers as a consultant and architect.
Uri has been building high performance technology products for more than 15 years. And he has helped life sciences organizations become more successful for the past 10 years, including eight years at Veeva. With experience across both commercial and R&D, Uri has worked closely on all three of Veeva’s software product lines. Currently, he is responsible for design, development, and overall success of the Vault RIM suite of applications.
Neelam is a Veeva customer success manager. In this role, she is responsible for ensuring that R&D customers are getting long term business value from their Veeva product. She has a wealth of experience in the definition, delivery and post implementation success of EDMS systems in life sciences. Neelam joined Veeva in 2014 and played a key role in the development and execution of the Veeva customer success program with R&D customers in Europe. Prior to this, Neelam was with Abbott Laboratories where she was responsible for implementing its EDMS suite of products and providing ongoing support.
John Tanner is a Senior Product Manager at Veeva based in Europe working in the Vault API & Tools Team. He is focused on delivering new platform features and easy-to-use tools for the rapid development of Vault Applications and also provides guidance and support to customers and services teams on third-party integrations. John has a strong background in implementation, systems integration and development following over 20 years’ experience in IT working across a number of market sectors.
Kate has experience partnering with life science companies of all sizes to implement innovative software solutions that keep pace with regulatory, technology, and industry rates of change. Kate has an extensive regulatory background including content management, submission compilation, and registration tracking. With more than twenty years’ experience in electronic document management and global regulatory submissions, Kate is a credible subject expert skilled at helping pharmaceutical and biotechnology companies worldwide find the most efficient way to leverage people, processes, and technology to meet the challenges of today’s evolving regulatory landscape.
As Vice President of Clinical Market Strategy at Veeva, Jim is responsible for customer engagement, market adoption, and strategic alliances. For the last 15 years, Jim has held a variety of senior positions in life sciences technology, where he has led software delivery and sales efforts in clinical operations, regulatory, clinical data standards, and content management.
Jim holds an MBA in Information Systems from Villanova University and a B.S. in Neuroscience from the University of Scranton.
Akos is responsible for Post Implementation Services in Europe. He works with customers in establishing and right-sizing operations and continuous innovation tracks, while overseeing all post go-live services activities in the region. Akos spent most of the decade focusing on the area of operations and maintenance in various roles in Veeva and Oracle Life Sciences before 2014.
Lauren Garson is a clinical research professional with over 20 years of experience in the management and monitoring of clinical trials. She began her career as a site coordinator and then moved on to Pfizer where she held various roles in the clinical operations organization during her 15 year tenure. Upon leaving Pfizer, Lauren has held various consulting positions focusing her expertise in Risk Based Monitoring, Statistical Analytics and Mobile Health technologies. As the Senior Director of Clinical Strategy at Veeva Systems, she helps customers obtain success utilizing Veeva Vault for eTMF, CTMS and Study Start Up.
Adam is a Vault application expert working in the EU R&D Services team. He began his journey at Veeva working across multiple R&D applications, currently focusing on Vault Clinical as Solution Architect for unified clinical projects across Europe.