Operationalizing ICH GCP E6(R3)

Pinar has +20 years of experience in strategy consulting, solution design and business development in the life sciences industry spanning from Large Pharma Sponsors through biotechs to CROs across clinical, medical and commercial operations. Her experience has been built on supporting life science Sponsors in implementing patient-centric and site solutions as well as designing pan-European product launch strategies across multiple therapeutic areas including oncology, Immuno-oncology, cardiovascular, gene therapies, diabetes and vaccines.

Francesca is an Engagement Manager in Veeva’s new Clinical Data Business Consulting practice, specializing in driving delivery excellence through holistic, cross-domain transformations. Drawing on three years at Veeva within Regulatory and Clinical Operations, she leverages a career background of 4.5 years in technology consulting and 2 years in health policy at NICE. Her work centers on process optimization, value assessments, efficiency diagnostics, and business readiness to help organizations navigate complex data landscapes and future-proof their Vault platforms.

With two decades of experience spanning clinical data management and clinical trials, Ibrahim has built a career at the intersection of science and technology. Now leading several of Novo Nordisk’s major clinical systems, he is focused on driving innovation, improving data handling, and accelerating trial processes to bring medicines to patients faster—all while maintaining the highest standards of quality and compliance.

Yulia holds an MSc in Life Science and Technology from EPFL. With extensive clinical operations experience, her career spans central laboratory services, global trial management, expanded access, strategic vendor sourcing and leadership. Driven by a passion for developing medicines for unmet medical needs, Yulia’s primary interests include recruitment optimization, process excellence, inspection readiness and talent development.

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

Emma brings over two decades of experience in clinical development and project management, leading global teams that transform scientific innovation into real-world impact. At Recordati, Emma heads a dynamic organisation driving clinical operations, data science, and digital solutions, championing portfolio governance and digital transformation to accelerate medicines to patients. Her leadership has shaped successful post-M&A integrations and delivered multiple FDA and EMA approvals for CNS treatments and rare disease therapies. With a PhD in Human and Medical Genetics, Emma combines scientific depth with strategic vision, inspiring teams to innovate, execute, and deliver meaningful outcomes for patients worldwide.

Drew’s career in pharmaceutical technology spans over 25 years and includes significant expertise in EDC, clinical site monitoring, and clinical trial management solutions. Drew’s innovative solutions in risk-based monitoring earned him a prestigious industry “Clinical Innovator of the Year” award in 2015 and he has authored multiple patents. Drew joined Veeva in 2016 to lead the ground-up design of Veeva’s clinical data management solutions. In his current role of Chief Technology Officer for Clinical Data, Drew collaborates with customers, partners, and the industry to set the vision and direction of Veeva’s Clinical Data product family.

Tom leads a team of product managers responsible for Veeva Clinical Operations. He has more than 10 years of experience leading development of eClinical solutions. He shares the belief that great products are built by listening to customers and putting them first.

Pierrick is Chief Operating Officer and a member of the Executive Committee at Excelya. He is responsible for overseeing operations across Europe and India while driving the company’s international growth and delivery capabilities. Prior to joining Excelya, he held several leadership positions at ALTEN, leading global business development, presales activities and international delivery organizations. With a background in engineering and extensive experience managing multicultural teams, Pierrick has built a career at the intersection of operational excellence, business transformation and international expansion.

Trevor works as an Executive Director at Syneos Health overseeing Biometrics partnerships with their strategic partners. Trevor has been with Syneos Health for over 28 years serving in many leadership positions within data management, programming and biostatistics. Trevor has a strong technical background in operational delivery, and has worked across the majority of industry leading systems, and rolled out & implemented a multitude of service solutions for Syneos’ strategic partners.

Sarah has more than 5 years experience across NHS, Pharma and CRO environments leading multidisciplinary teams. She is a strategic FSP leader specializing in creating unique global FSP solutions for customers who require high performing, adaptable teams ready to challenge ways of working to raise the bar to exceed what is required today and in our future.