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.
Sjaak is a senior CSV Compliance and Validation Consultant and responsible for Life Sciences QE&A CSV services in Europe.
He has 25+ years understanding and working experiences in Life Sciences and Pharmaceutical Industry delivering Computer System Validation and Computer Software Assurance services and consultancy.
Sjaak has a good understanding and working experiences of GCP, GLP, GMP, GDP, GAMP5®, EU Annex 11, 21 CFR Part 11 and QMS.
And has working experiences with industry regulations GS1, ICH, EMA, PIC/Sand country regulations.
Workshop: Computer Software Assurance (CSA) and Critical Thinking during Verification and Validation (V&V)
Joe is a seasoned professional in the realm of Computerised System Validation (CSV) with a deep understanding of Good Laboratory Practice and Good Clinical Laboratory Practice.
Joe's career also includes a significant tenure at a Contract Research Organisation (CRO), where he excelled as a Support Systems Developer and a Higher Technician. Here, he played a crucial role in developing, maintaining, and supporting a range of web applications, databases, and information systems, along with leading initiatives in GLP Computerised System Validation and Data Integrity practices.
His professional journey is furthermarked by awards and recognitions, including the “Chemical Sciences” Apprenticeof the Year by the Royal Society of Chemistry and the “Advanced Apprentice ofthe Year” for Yorkshire and Humber by the National Apprenticeship Service.
Workshop: CSV Approaches for GLP/ GCLP
Sophie is an experienced Managing Partner with a demonstrated history of working in the management consulting industry.
Strong entrepreneurship, professional skilled in Data Governance, Data Quality, MDM and Privacy & Personal Data Protection.
Sophie is your Agile Data Governance Coach
Workshop: Agile Data Governance
Simon is a passionate about technology and IT.
With a background as Industrial Engineer, he actively participate in the development of a design office specialised in Life Sciences Automation.
Thanks to his deep experience and expertise since 10 years as Head of Technology, Simon created and challenged the design and test methodologies for the C&Q phases both for the internal service but also for the customers, through customised guidelines.
To support this transition to a digital world, Simon provides also automation and IT/OT training.
Workshop: Enabling more efficient and effective C&Q through GEP (Good Engineering Practices)
Christophe supports pharma and medical device customers on the best use of agile methodology in GxP environment, as well as validation of AI in GxP/Medical Device.
Christophe is member of the Steering Committee of GAMP Francophone and member of the SIG “AI in GxP” from GAMP DACH.
Workshops:
CSV for AI-besed systems
Agile Methodology for Commissioning Qualification Validation (CQV) and Verification & Validation (V&V) projects - Co-presenting
After more than 20 years in the pharmaceutical industry, Philippe joined Dassault Systèmes Group, leader in digital twins and virtual universes, enabling its customers to imagine sustainable innovations capable of harmonizing products, nature and life.
Philippe's expertise lies in supporting regulated customers on the deployment of 3DEXPERIENCE cloud platform; XaaS in regulated environment, as well as validation of applications and AI.
He is chair of ISPE – France Affiliate since 2022.
He is also a founding members of the Steering Committee of GAMP Francophone (2006)
He leads the GAMP.fr "agility in the GxP environment" working group.
Workshop: Agile Methodology for Commissioning Qualification Validation (CQV) and Verification & Validation (V&V) projects - Co-presenting
Jan-Bart is heading the European medical device team of ProPharma, located in Leiden, the Netherlands.
He and his team provide services in various medical device areas such as quality management systems (ISO13485), regulatory affairs and clinical strategy (MDR and IVDR).
Workshop: Software as Medical Devices (SaMD) and the impact of the application of AI on Validation - Co-presenting
Bob is Associate Director CSV & Data Integrity for EU and UK/IRL of the global validation team of ProPharma.
As a practitioner and auditor, Bob has performed various validation resiliency projects and Data Integrity assessments to define the IT readiness for drug product and medical device launches.
Workshop: Software as Medical Devices (SaMD) and the impact of the application of AI on Validation - Co-presenting
Inssata has over sixteen years of experience in Information Systems security, particularly in cybersecurity, cloud computing, and data protection within national and international organisations across various sectors such as banking, insurance, nuclear, energy, water, airport, transportation, healthcare, defense, etc.
She specialises in data protection, cybersecurity, including medical device security, cloud, and Artificial Intelligence.
In this capacity, she founded her cybersecurity consulting and training firm, INSSATAD CONSULTING, which not only assists in defining cybersecurity strategies but also transforms regulatory and operational constraints of organizations into growth opportunities.
Furthermore, she initiated an Ethical Hacking initiative (Black Is Ethical) with the goal of bringing together hackers, showcasing their skills in Africa and internationally, and contributing to both their professionalisation and recognition by political decision-makers.
She guides organisations in obtaining certification for hosting health data (HDS) as well as ISO 27001, ISO 20000, ISO 14001, ISO 9001. Additionally, she conducts audits on these systems as a certification auditor on behalf of certification bodies.
Workshop: Cybersecurity using AI in Medical Devices Industries - Co-presenting
Tanja is working in Pharma industry for 30 years.
She has 10 years’ experience in CSV & Data Integrity.
Part-time freelancer advising companies on the topic of Data Integrity and CSV.
Member of Special interest group (SIG): ‘Audit Trail Review’ (GAMP D-A-CH)
Workshop: Analytics Equipment - Qualification and Validation
Magali has experience with CSV and Data Integrity topics.
She has a good understanding and working experiences of GLP, GMP, GDP, GAMP5®, EU Annex 11 and 21 CFR Part 11.
She supports Data Integrity Remediation project for several Pharma customers especially in QC laboratories with a strong knowledge of analytical systems.
Workshop: A Risk-Based Approach for Audit Trail Review - Co-presenting
Camille's profound passion for science, technology, and entrepreneurship drove him to co-found Ellion in 2020, where he seamlessly amalgamated these three interests.
The brainchild of his visionary pursuits, The Pharmaverse, stands as the pioneering learning Metaverse specifically tailored for the bio-pharmaceutical realm.
Workshop: Pharmavers, the VR-training for the pharma ecosystem
With 15 years of expertise in Artificial Intelligence and Information Technology, Cédric has excelled in strategic advising, research and development,and capacity building across diverse sectors, including Healthcare,Manufacturing, Finance, Transportation & Automotive, Agriculture, and Security.Previously,
He served as a researcher and lecturerat the Vrije Universiteit Brussel (VUB), specifically in the Department of Electronics and Computer Science (ETRO). Currently, he holds the position of Guest Professor at Mapon University, the Catholic University of Bukavu, and the Nouveaux Horizons University in the Democratic Republic of Congo (DRC). In these esteemed roles, he imparts knowledge in Artificial Intelligence, Electronics, and Computer Science.
Recognized as a rigorous problem-solver, Dr.OVENEKE is committed to Human-centered technological innovation and entrepreneurship. His eagerness to embrace new challenges is complemented byhis proficiency as a polyglot and an excellent communicator. Driven by amission to empower every individual and organization to progress, he embodies aforward-thinking approach to advancing the field of Artificial Intelligence.
Workshop: Cybersecurity using AI in Medical Devices Industries - Co-presenting
Houssame has worked in the cosmetics, Medical Devices and pharmaceutical industries for 17 years.
He has 10 years of experience in CSV and data integrity. As a Senior Consultant, he advises, trains and audits companies on Data Integrity and CSV
Workshop: A Risk-Based Approach for Audit Trail Review - Co-presenting
Xavier has experience with Data Integrity remediation, CSV and system administration.
He has worked on GxP and OT systems at various stages of their lifecycle, from system implementation to system migration and routine maintenance and administration.
Workshop: A Risk-Based Approach for Audit Trail Review - Co-presenting
Jordan brings over 13 years of experience in CSV, engineering, and validation to his role.
His work spans from implementing DCS systems to conducting gap assessments in legacy systems, guided by standards like GAMP5®,EU Annex 11, and 21 CFR Part 11.
As the lead at RealDev Academy, Jordan focuses on sharing his knowledge, emphasizing a patient and clear teaching style that makes complex subjects accessible.
Jordan's workshop will cover practical strategies for identifying and addressing gaps in data integrity, essential for maintaining system compliance and reliability in the pharmaceutical sector.
Workshop: Data Integrity - Gap Assessment and Remediation Plan
