Speakers

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 O'Connor

C&Q DigitalTransformation Manager

At No Deviation

Ireland

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 Chevillon

Expert Regulatory Compliance - DORA, NIS2, ISO27001

At MEAT

France

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?

John Cheshire

CSV & Digital Quality Consultant

At Headway Quality Evolution


United Kingdom

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 Gubellini

Chief Regulatory Officer

At SoftComply


Ireland

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.

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