All plenary sessions are composed of recognized experts in the pharmaceutical, biotechnological, and medical device sectors, to ensure the relevance of the topics addressed during the sessions, and to represent the diversity of the CSV’s impacts in those sectors.
For the Plenary Sessions we are particularly attentive to the search for innovative approaches and techniques to improve Computerized System Validation, highlighting the latest trends and innovations in the field.
Younes combines his engineering and business management background to optimize processes in the industrial sector. His role involves overseeing operations, improving processes, and enhancing team performance.
Younes's proactive approach and dedication to operational excellence have positively impacted his organization.
He leads RealDev, an international Technologies and Management Group, helping their clients to improve effectiveness and enhance performance, by providing only the most innovative solutions.
His challenge within this organization is to share with their customers the knowledge he did acquire through his experience within Engineering and IT sectors.
Plenary Session: Artificial Intelligence & Digital Twins
David is a Digital Transformation Lead with 9 years of experience in the life sciences sector.
He holds an MSc in Process Validation and Regulatory Affairs and an MSc in BigData Analytics and AI.
David specialises inquality management and computer system validation, ensuring that digital solutions meet regulatory standards, including GAMP5, GxP, and FDA 21 CFR Part11. His expertise in quality processes has been central to leading initiatives such as implementing SAP ERP, LIMS, and data analytics tools, significantly improving process efficiency and data management.
David's work bridges quality, technology, and regulatory compliance, driving digital transformation in the life sciences industry.
Plenary Session: Data Integrity & Digital Transformation
Nadia is a highly experienced professional specializing in IT Compliance and Computerized System Validation (CSV). Currently, she serves as the Head of IT Compliance Solutions at UCB.
In her role, Nadia is responsible for overseeing IT Compliance strategies, ensuring that company's IT systems adhere to regulatory standards, and implementing robust compliance frameworks.
Nadia's career is marked by her expertise in CSV, project management, strategic planning, and cross-functional team leadership. She has proven track record of driving business success through innovation and effective process optimization. her leadership has been instrumental in managing various global projects and developing strategic initiatives that enhance organizational efficiency.
Plenary Session: Data Integrity & Digital Transformation
Mathieu, Quality, Compliance and IT Leader with over 20 years of experience in Bio-pharma industries.
Strong experiences in GMP/GDP/GLP (Engineering, Industrial, Manufacturing, Laboratory and Supply Chain) and Medical Device Software projects, design and development process.
He is a proven expert in Manufacturing, Laboratory Systems and Industrial Systems and leads cross-functional projects focusing on Digital Compliance and Cyber-security aspects.
His technical and quality knowledge support a long-term goal in the Data Integrity space.
Plenary Session: Data Integrity & Digital Transformation
Sachin brings over 25 years of strategic IT leadership. His expertise lies in digitizing quality processes, managing complex IT projects, and ensuring regulatory alignment.
Sachin has a proven track record in software quality, infrastructure qualification, GxP compliance, IT Risk Management, and program delivery across IT and pharmaceutical industries. His domain knowledge in e-compliance is robust, particularly in GxP, 21 CFR Part 11, Annex 11, and GAMP 5 projects.
Sachin’s leadership extends beyond the corporate realm. He served as a member of the Board of Directors for ISPE India Chapter from 2020 to 2022 and was the ex-chairman of ISPE GAMP India Steering, the apex body of CSV and e-compliance professionals from 2018 to 2020.
In international forums, Sachin has spoken in over 65+ conferences, sharing insights on CSA, cloud computing, and AI. His commitment to advancing compliance practices and fostering innovation underscores his impact in the industry. His consulting work on Data Integrity and CSV framework digitization has been instrumental in guiding organizations towards compliance excellence.
His key interest centers around digitizing IT compliance processes, and he has played a pivotal role in areas such as quality, IT processes, infrastructure, manufacturing, and QC business domains.
Plenary Session: Quality Management Systems 2.0: Embracing Digitalization and Automation in Pharma 5.0
Ludivine is a "CSV Compliance Guide" and CEO of IPARDIS Consulting.
Previously managing the GxP Compliance of Corporate Computerized Systems in a veterinary health industry and CSV consultant for several Life Sciences Industries; she became freelancer and founder of the A38 Program - supporting consulting companies and Life Sciences Companies.
Today, and for the last 15 years, she has been helping them handling data integrity through the compliance of computerized systems.
Ludivine has navigated between 12 Life Sciences Industries, from pharma to cosmetics, and has made GxP computerized system compliance its playground since 2007. As a temporary teacher for the University of Bordeaux and mentor, she guided dozen of apprentices, trainees, or juniors, and met more than 120 students in master's degree or professional's degree.
She enjoyed making Data Integrity playful thanks to her card game named "ALCOA - The Serious Game". She has validated more than 30 computerized systems, audited IT Infrastructures, supported ISO 27001 certifications and passed the FDA race.
Ludivine is an active member of the SOFAQ (the Quality Assurance French Company); she leads the GxP Computerized Systems committee and shares best practices in CSV Compliance.
Plenary Session: Data Integrity and Digital Transformation
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.
Plenary Session: Artificial Intelligence & Digital Twins
Audrey is a seasoned expert in quality and regulatory affairs, specializing in medical devices. Forover twenty years, she has brought her expertise and technical leadership to the medical device industry, encompassing Class I to III devices.
With a Doctorate in Pharmacy, she works as a consultant in quality and regulatory affairs for medical devices, where she has gained significant experience in various critical aspects of the field. Throughout her career, Audrey has been instrumental in implementing quality management systems within innovative startups such as Doc2U and Medical Intelligence Service, helping to structure and optimize their processes.
Her expertise has been crucial in assisting these companies in obtaining the CE marking in accordance with Regulation 2017/745 for their software projects or medical devices incorporating software, thereby ensuring their compliance with European regulatory requirements.
Her pragmatic approach and ability to quickly adapt to the specific needs of each company are major assets. She offers rapid and effective integration within teams, facilitating the implementation of tailored solutions, particularly by closely collaborating with technical and software development teams. Her thorough mastery of key regulatory and normative references, such as Directive 93/42/EEC, Regulation (EU) 2017/745, MDCGs, EN ISO 14971, EN ISO 13485, and EN IEC 62304, attests to her solid competence in the field
Plenary Session: Artificial Intelligence as a Medical Device and its use for qualification
Olivier is a seasoned IT executive with extensive experience in technical leadership and innovation. Since November 2023, he has been the Quality Method and Cyber-security Manager for SEBIA's R&D Software and Firmware Department.
His achievements include designing a validation package for non-symbolic AI and revamping qualification methods in Agile mode. From August 2021 to November 2023, he served as the Technical Director at Medical Intelligence Service, where he redesigned the AI Medvir database and led technical projects, including the AccelRare® project for Sanofi, achieving ISO 13485 & IEC 62304 certification.
Olivier's career is marked by a succession of roles in innovative startups, where he has consistently driven technological advancement. As Technical Director, overseeing the development of the SI master plan and prove of concept for mobile apps, transitioned the IT system and managed external maintenance, co-conceived the business plan and designed the IT system, developed a SaaS offering.
His contributions in these roles have been pivotal in fostering growth and innovation within these startups.
Earlier in his career, Olivier managed IT systems, focusing on digital transformation, governance tools, and departmental improvements, includes project management and development roles at Lilly France, specializing in system migrations, team management, and technical project execution. Olivier has knowledge in multiple programming languages, databases, and standards, reflecting his broad expertise and leadership in the tech industry.
Plenary Session: Artificial Intelligence as a Medical Device and its use for qualification
