As the ICSVC mantra
“It is great to do what you love but greater with the great team.”
(by Lailah Gifty Akita; Think Great: Be Great!)
Let’s be submerged by great insights coming from European peers.
Grow your expertise and network.
Dave is an active member of the ISPE C&Q Digital Validation subcommittee and has published several articles on the subject of Digital Validation Tools (DVT’s).
He was a Chapter Lead for the ISPE Good Practice Guide for Digital Validation Tools published in 2025.
He also holds a role as CQV Portfolio Manager at MSD, Tipperary, Ireland where he is responsible for implementation of Digital Validation across multiple CAPEX Projects.
Workshop: Digital Validation
Gilles brings a strategic and hands-on perspective on IT governance in Life Sciences, bridging cybersecurity, regulatory frameworks such as NIS 2 and ISO 27001, and operational realities.
He helps organizations translate complex regulatory requirements into resilient, compliant and inspection-ready digital governance models
Plenary Session: IT Gouvernance (NIS 2 - ISO 27001), what's to integrate for Life Science Industries?
Guglielmo is a Biomedical Engineer with an extensive background in Software Engineering, Data Science and ML/DL applied to different contexts, such as Biotech Manufacturing, Healthcare and DevOps, just to mention the latest.
He is involved in the implementation of an automated visual inspection system which provides Advanced Analytics and AI for generating business insights on rejected product images. This inititive won the Manufacturing Leadership Award 2021 in the "Advanced Analytics and Artificial Intelligence Leadership" category.
He is a distinguished Member of the American Society for Artificial Intelligence.
Plenary Session: Using AI : the limitations of the risk-based approach
Greg is advises global organisations across regulated sectors, including pharma, on cybersecurity, data protection, privacy and incident response, bringing both legal depth and real-world business insight.
He is the Co-Managing Partner of the Eversheds Sutherland Budapest (HU).
Balancing practice with academia, he also servesas an Adjunct Professor at the world-renowned emlyon business school, a global top 40institution in Lyon (FR).
Greg also plays an active role in the professional cybersecurity community: he is a board member of the Cybersecurity Advisors Network (CyAN) in Paris and participating in high-level expert groups at the European Commission , giving him a broad perspective on how cyber risk, regulation, and organisational resilience intersect.
Plenary Session: IT Gouvernance (NIS 2 - ISO 27001), what's to integrate for Life Science Industries?
Jean-Luc brings a unique perspective shaped by decades of experience across public and private organizations, and by his active contribution to global project management standards.
Co-author of two global standards: Standard for AI in PPPM, PMBOK® Guide v7
Contributor for the PMBOK® Guide v8 and three other standards
International Speaker: PMI Global Summits
Plenary Session: Agile vs Waterfall Is Over: How Hybrid Project Management Enables Digital & AI Adoption in Life Sciences
Christoph has an extensive experience in highly regulated Life Sciences environments, including:
Medical Devices, Quality Management Systems, GLP & GCP and Medicinal products.
Beyond his consulting activities, Christoph is also a lecturer and industry speaker, known for his ability to translate complex regulatory requirements into clear, actionable insights.
Plenary Session: Panel Discussion - Evolution of the Regulations
John is CSV & Digital Quality at Headway Quality Evolution and Secretary of ISPE GAMP UK — a role that places him at the heart of industry thinking on modern validation, risk-based approaches, and evolving regulatory expectations.
He is passionate about supporting regulated Life Sciences organisations to better understand risks in their own data lifecycles and identifying solutions to strengthen data integrity and governance.
Workshop: Strengthening Data Integrity with Data Flow Mapping
The workshop will explore why data flow mapping has become a key regulatory hot topic and how it underpins effective data governance. Participants will have an opportunity to define data flow maps and use them to uncover hidden data integrity risks and strengthen process controls.
Matteo is Chief Regulatory Officer at SoftComply, with strong expertise in regulatory compliance, quality systems and cloud-based solutions for regulated industries.
He supports organizations, particularly in MedTech, in aligning digital platforms with global regulatory and GxP requirements.
Workshop: Continuous Validation
Continuous validation uses automated, periodic tests to confirm cloud services remain in a validated state over time. It complements — not replaces — the required initial, comprehensive system validation. In regulated fields like MedTech and Aerospace, it supports ongoing compliance, audit readiness, and documented assurance despite frequent provider-driven changes. Join us to hear about continuous validation of Atlassian Confluence Cloud.
Fouad works at the intersection of Artificial Intelligence, digital transformation, and regulatory compliance in pharmaceutical environments.
He supports organizations in moving from experimentation to scalable, value-driven AI initiatives.
Speaker, trainer and author of several articles, Author of the book ‘The First Steps of Artificial Intelligence in the Pharmaceutical Industry’
Workshop: AI Adoption in LifeSciences Projects & Initiatives
Plenary Session: Panel Discussion - Evolution of the Regulations
Miguel is paving the way for medical device software regulatory compliance across the globe with digital tools and AI.
Ph.D. Candidate in Bioengineering Systems at MIT-Portugal Program, focused on designing new adaptive regulatory strategies and public policies for harnessing health technology innovation, from cell therapies to digital health, with better utilization of healthcare data.
Workshop: IT Infrastructure Platforms, what is DevOps, and it use for IaC - Infrastructure as Code?
Renaud is an experienced Chief Information Security Officer (CISO), IT Auditor, and certified trainer specializing in IT risk management and cybersecurity compliance.
With a strong background in governance, security operations, and regulatory frameworks, he supports organizations in strengthening their IT control environment while aligning with international standards such as ISO 27001, NIS2, SOx, and SOC 2.
Workshop: IT Gouvernance (NIS 2 - ISO 27001), what's to integrate for Life Science Industries?
Ella holds MSc EE and MBA and she is an accomplished regulatory professional with over 20 years of experience in the medical device and in vitro diagnostics industries, where she help organizations navigate complex regulatory environments while ensuring the highest standards of quality.
Over the course of her career, she has held leadership roles at Medical device and IVD manufacturers and Notified body, heading Regulatory and Quality departments at Intertek Medical Notified Body AB (IMNB AB) , Vice-Chair of the NBCG-Med Technical Group, as a participant and chair of multiple Team NB working groups.
Ella is acting as Co-Chair and Country Lead for Sweden in RAPS Nordic Local Networking Group and is proud contributor to the Regulatory Affairs Professionals Society.
Plenary Session: Panel Discussion - Evolution of the Regulations
