Meet the COSUP
Supervisory Committee for the CR.GDPR Code of Conduct
The Code’s Supervisory Committee (COSUP) is the accredited monitoring body responsible for overseeing adherence to the EUCROF GDPR Code of Conduct for Service Providers in Clinical Research.
Made up of experienced professionals from across the clinical research sector, COSUP assesses organisations applying to adhere to the Code and monitors ongoing compliance with its requirements. Together, the Committee helps ensure the Code is applied consistently, transparently and in accordance with the governance framework approved by the French Data Protection Authority (CNIL).
Meet the COSUP Members below:
Chair | Victoria Watts
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British lawyer with qualifications in data protection: Certified Information Privacy Technologist (CIPT) and Certified Information Privacy Professional with a focus in Europe (CIPP/E), and holder of a Practitioner Certificate in Data Protection (“PC.dp.”). Victoria Watts has a Bachelor degree from Royal Holloway, University of London, a Master of Studies from Oxford, and an LLB from the University of Law. She has 10+ years’ experience in senior leadership roles in the area of global compliance and data protection for multinationals in a range of industries and the last 9 years of those have been in pharmaceuticals and clinical research.
Currently fully employed as Vice President, Compliance Officer for Premier Research and responsible for overseeing Premier Research’s global data protection strategy and implementation to ensure compliance.
Ms Watts was a key writing contributor and lead editor to the European CRO Federation (EUCROF) initiative to draft the GDPR Code of Conduct and has been elected the first Chair of the COSUP, responsible for overseeing the operations of the accredited supervisory committee in order to fulfil the mission and mandate of CR.GDPR.
Christophe Maes | Vice Chair
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- Bachelor’s degree Medical school University Ghent
- Master’s degree Medical Rehabilitation University Ghent
- Certified internal and external auditor and auditor trainer, I have assessed compliance with the Qmentum standard, an ISQUA internationally certified health hospital quality management system standard, in Belgian and Dutch hospitals.
- Development and implementation of training courses for both internal and external auditors.
- Commitment to data protection and privacy compliance, playing a pivotal role in creating criteria and certification schemes for GDPR compliance in digital health technologies, especially those processing and controlling health data.
- Expert in developing implementation, requirements and playbooks for digital health technology developers to ensure compliance with GDPR, EHDS, and the AI Act.
- Strong background in developing and implementing procedures to ensure compliance with ISO Standards 17065 and 17024.
- Creating ISO 17000-compliant certification schemes
- Involved in EU – Horizon and IHI R&D projects as Task – or Work Package lead related to:
- Data privacy – data governance
- Data management Plans
- Compliance checks Digital Health Tools – GDPR – Data Act – EHDS – AI Act
Dimitrios Athanasiou
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European Medicines Agency PCWP Member; World Duchenne Organization Board Member; European Patient Forum Ethics Board Chair; Greek Patients Association Board Member; Rare Diseases Greece Vice Chair
Dimitrios Athanasiou holds a BA in Business Administration and an MBA in Financial Management. He speaks three European languages and has more than 25 years of experience with international business projects, working in various countries in consulting, developing, and reorganising companies. When his son was diagnosed with Duchenne Muscular Dystrophy, a fatal and incurable rare disease, he became a strong international patient advocate in Duchenne and Rare Diseases. He was a board member of the European Patient Forum EPF, the umbrella of the patient organisations in Europe. He is a founding member and serves on the Board of the Greek Patients Association and is currently the Vice Chair of Rare Diseases Greece. In 2014 he was nominated patient expert by EMA for DMD and has participated in several of EMA’s Scientific Advice, SAG, Protocol Assistance, and CHMP pilot meetings for Duchenne, providing the essential patient representative perspective when companies request regulatory advice or approval. He was a PDCO member in the European Medicines Agency till 2023 and is currently a PCWP member.
Pierre-Henri Bertoye
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CLINICAL RESEARCH, BIOTECH/PHARMA
Senior management in non clinical, clinical trial and pharmacovigilance on a global scale, with high expertise in Clinical Regulatory Affairs, Quality and Audit.
Proven track record of successful thoughtful contribution to the development of worldwide implementable strategies, regulations, and system developments for clinical trial implementation and control.
Marc Brooks
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Marc Brooks is the founder and general manager of elderbrook consulting GmbH in Tägerwilen, Switzerland and Partner of QAN Quality and Audit Network GmbH in Hamburg, Germany. The services of elderbrook consulting are focused on quality management relating to the use of electronic solutions in clinical trials for the pharmaceutical and medical device industry, e.g. audits, training, consulting, writing SOPs, and validation management. This covers not only topics such as IT security, Data Privacy, and Computer System Validation, but also all processes relating to data acquisition.
The idea of QAN Quality and Audit Network is to use our experience and network to offer support for the pharmaceutical-, biotech-, medical device and CRO industry by conducting audits, mock inspections, inspection support, gap analyses and development of quality management systems.
Ricard Martinez
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Ricard currently works at the University of Valencia as a lecturer in the Department of Constitutional Law, Political Science and Public Administration, and is Director of the Chair in Privacy and Digital Transformation. He holds a PhD in Law from the University of Valencia and has devoted his research to the study of the fundamental right to data protection and various issues relating to the impact of information and communications technologies on privacy. He is a member of the panel of experts on data and artificial intelligence at the Regional Ministry of Innovation and Universities of the Valencian Regional Government. Member of the expert group tasked with drafting a Charter of Digital Rights for the State Secretariat for Digitalisation and Artificial Intelligence within the Ministry of Economic Affairs and Digital Transformation. He has served on the Working Group on Citizens’ Digital Rights at the Ministry of Energy, Tourism and the Digital Agenda and coordinated the Working Group set up by the set up by the Conference of Rectors of Spanish Universities (CRUE-TIC) to promote the General Data Protection Regulation. He has worked as a database control specialist at the University of Valencia. He is President of the Spanish Professional Association for Privacy. He has worked with various universities as a lecturer on undergraduate and postgraduate courses and has been head of the Research Department at the Spanish Data Protection Agency. He is the author of several research papers on this subject – “Tecnologías de la Información, Policía y Constitución”, “Una aproximación crítica a la autodeterminación informativa”- and has also contributed as an author or editor to various commentaries on the Regulations implementing the Organic Law on Data Protection, and to research papers on law and social media or cloud computing, as well as other specialist publications.
Anastassia Negrouk
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Belgian data protection professional specialising in clinical research compliance, certified Data Protection Officer (Solvay, 2018), with a Master’s degree in Biology.
Over 25 years’ experience in clinical cancer research and 8 years as a Data Protection Officer. Extensive expertise in GDPR, the Clinical Trials Regulation and the In Vitro Diagnostic Medical Devices Regulation, including publishing on their impact on international clinical research.
Currently Chief Operating Officer at MyData-TRUST, where she oversees global operations and provides data protection services to sponsors, CROs and research institutions. She also acts as Data Protection Officer for several clients.
Contributed to drafting the EUCROF GDPR Code of Conduct as a member of the EUCROF Working Group and now serves on the COSUP, supporting implementation of the Code and consistent interpretation across the sector.
Kate Smirnova
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- Based in Switzerland, LLM (Master in Privacy, Cybersecurity and Data Management, Maastricht University, NL); Certified Information Privacy Professional for Europe (CIPP/E), USA (CIPP/US), Asia (CIPP/A) and Certified Information Privacy Technologist (CIPT).
- 17+ years’ experience in the domain of clinical research carrying out auditing, compliance and data protection roles for a multinational CRO.
- Presently, full-time employed as Data Protection Officer at PSI CRO AG (Zug, Switzerland) and responsible for overseeing PSI’s global data protection program.
- From 2018, member (later, co-chair) of the task force established by the European CRO Federation (EUCROF) for the GDPR Code of Conduct initiative.
Chair
Victoria Watts
Premier Research
British lawyer with qualifications in data protection: Certified Information Privacy Technologist (CIPT) and Certified Information Privacy Professional with a focus in Europe (CIPP/E), and holder of a Practitioner Certificate in Data Protection (“PC.dp.”). Victoria Watts has a Bachelor degree from Royal Holloway, University of London, a Master of Studies from Oxford, and an LLB from the University of Law. She has 10+ years’ experience in senior leadership roles in the area of global compliance and data protection for multinationals in a range of industries and the last 9 years of those have been in pharmaceuticals and clinical research.
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- Currently fully employed as Vice President, Compliance Officer for Premier Research and responsible for overseeing Premier Research’s global data protection strategy and implementation to ensure compliance.
- Ms Watts was a key writing contributor and lead editor to the European CRO Federation (EUCROF) initiative to draft the GDPR Code of Conduct and has been elected the first Chair of the COSUP, responsible for overseeing the operations of the accredited supervisory committee in order to fulfil the mission and mandate of CR.GDPR.
Vice Chair
Christophe Maes
i-HD
Bachelor’s degree Medical school University of Ghent, Master’s degree Medical Rehabilitation University of Ghent, certified internal and external auditor and auditor trainer, I have assessed compliance with the Qmentum standard, an ISQUA internationally certified health hospital quality management system standard, in Belgian and Dutch hospitals.
-
- Development and implementation of training courses for both internal and external auditors.
- Commitment to data protection and privacy compliance, playing a pivotal role in creating criteria and certification schemes for GDPR compliance in digital health technologies, especially those processing and controlling health data.
- Expert in developing implementation, requirements and playbooks for digital health technology developers to ensure compliance with GDPR, EHDS, and the AI Act.
- Strong background in developing and implementing procedures to ensure compliance with ISO Standards 17065 and 17024.
- Creating ISO 17000-compliant certification schemes
- Involved in EU – Horizon and IHI R&D projects as Task – or Work Package lead related to:
- Data privacy – data governance
- Data management Plans
- Compliance checks Digital Health Tools – GDPR – Data Act – EHDS – AI Act
Dimitrios Athanasiou
European Medicines Agency | European Patients’ Forum
European Medicines Agency PCWP Member; World Duchenne Organization Board Member; European Patient Forum Ethics Board Chair; Greek Patients Association Board Member; Rare Diseases Greece Vice Chair. Dimitrios Athanasiou holds a BA in Business Administration and an MBA in Financial Management. He speaks three European languages and has more than 25 years of experience with international business projects, working in various countries in consulting, developing, and reorganising companies.
-
When his son was diagnosed with Duchenne Muscular Dystrophy, a fatal and incurable rare disease, he became a strong international patient advocate in Duchenne and Rare Diseases. He was a board member of the European Patient Forum EPF, the umbrella of the patient organisations in Europe. He is a founding member and serves on the Board of the Greek Patients Association and is currently the Vice Chair of Rare Diseases Greece. In 2014 he was nominated patient expert by EMA for DMD and has participated in several of EMA’s Scientific Advice, SAG, Protocol Assistance, and CHMP pilot meetings for Duchenne, providing the essential patient representative perspective when companies request regulatory advice or approval. He was a PDCO member in the European Medicines Agency till 2023 and is currently a PCWP member.
Pierre-Henri Bertoye
WHO | P-H BERTOYE Conseil
Senior management in non clinical, clinical trial and pharmacovigilance on a global scale, with high expertise in Clinical Regulatory Affairs, Quality and Audit. Proven track record of successful, thoughtful contribution to the development of worldwide implementable strategies, regulations, and system developments for clinical trial implementation and control.
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In his current consulting role, Pierre is a consultant in clinical development, including regulatory pathways, GCP training, development and audits, providing regulatory advice in clinical development, clinical Trial audits, and training in clinical trials. In developing countries, he helps with the capacity building of Regulatory Authorities, Regulatory and feasibility assessment of clinical implementation programs and clinical trials, and clinical trial audits. He also works as an advisor for the WHO, where he is a capacity-building advisor for developing countries: assessment and training programmes for National Regulatory Authorities (NRAs) in the implementation of their regulatory system, marketing authorisation and clinical trial monitoring, as well as a Regulatory advisor and auditor of WHO-led or coordinated trials.
Marc Brooks
elderbrook consulting GmbH
Marc Brooks is the founder and general manager of elderbrook consulting GmbH in Tägerwilen, Switzerland and Partner of QAN Quality and Audit Network GmbH in Hamburg, Germany.
-
The services of elderbrook consulting are focused on quality management relating to the use of electronic solutions in clinical trials for the pharmaceutical and medical device industry, e.g. audits, training, consulting, writing SOPs, and validation management. This covers not only topics such as IT security, Data Privacy, and Computer System Validation, but also all processes relating to data acquisition.
The idea of QAN Quality and Audit Network is to use our experience and network to offer support for the pharmaceutical-, biotech-, medical device and CRO industry by conducting audits, mock inspections, inspection support, gap analyses and development of quality management systems.
Ricard Martinez
University of Valencia
Ricard currently works at the University of Valencia as a lecturer in the Department of Constitutional Law, Political Science and Public Administration, and is Director of the Chair in Privacy and Digital Transformation. He holds a PhD in Law from the University of Valencia and has devoted his research to the study of the fundamental right to data protection and various issues relating to the impact of information and communications technologies on privacy.
-
He is a member of the panel of experts on data and artificial intelligence at the Regional Ministry of Innovation and Universities of the Valencian Regional Government. Member of the expert group tasked with drafting a Charter of Digital Rights for the State Secretariat for Digitalisation and Artificial Intelligence within the Ministry of Economic Affairs and Digital Transformation. He has served on the Working Group on Citizens’ Digital Rights at the Ministry of Energy, Tourism and the Digital Agenda and coordinated the Working Group set up by the set up by the Conference of Rectors of Spanish Universities (CRUE-TIC) to promote the General Data Protection Regulation. He has worked as a database control specialist at the University of Valencia. He is President of the Spanish Professional Association for Privacy. He has worked with various universities as a lecturer on undergraduate and postgraduate courses and has been head of the Research Department at the Spanish Data Protection Agency. He is the author of several research papers on this subject – “Tecnologías de la Información, Policía y Constitución”, “Una aproximación crítica a la autodeterminación informativa”- and has also contributed as an author or editor to various commentaries on the Regulations implementing the Organic Law on Data Protection, and to research papers on law and social media or cloud computing, as well as other specialist publications.
Anastassia Negrouk
MyData-TRUST
Belgian data protection professional specialising in clinical research compliance, certified Data Protection Officer (Solvay, 2018), with a Master’s degree in Biology. Over 25 years’ experience in clinical cancer research and 8 years as a Data Protection Officer. Extensive expertise in GDPR, the Clinical Trials Regulation and the In Vitro Diagnostic Medical Devices Regulation, including publishing on their impact on international clinical research.
-
Currently Chief Operating Officer at MyData-TRUST, where she oversees global operations and provides data protection services to sponsors, CROs and research institutions. She also acts as Data Protection Officer for several clients.
Contributed to drafting the EUCROF GDPR Code of Conduct as a member of the EUCROF Working Group and now serves on the COSUP, supporting implementation of the Code and consistent interpretation across the sector.
Kate Smirnova
PSI CRO AG
Based in Switzerland, LLM (Master in Privacy, Cybersecurity and Data Management, Maastricht University, NL); Certified Information Privacy Professional for Europe (CIPP/E), USA (CIPP/US), Asia (CIPP/A) and Certified Information Privacy Technologist (CIPT). 17+ years’ experience in the domain of clinical research carrying out auditing, compliance and data protection roles for a multinational CRO.
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Presently, full-time employed as Data Protection Officer at PSI CRO AG (Zug, Switzerland) and responsible for overseeing PSI’s global data protection program.
From 2018, member (later, co-chair) of the task force established by the European CRO Federation (EUCROF) for the GDPR Code of Conduct initiative.
Pierre Westphal
GDPieRre Consulting/SGS Partner
Team Builder with proven track records in BtoB sales transformation and international development. Passionate about multicultural cross-group collaboration. Acknowledged for inspiring, developing and leading teams. Strong entrepreuneurial drive and ability to solve issues in a creative way. Instrumental in developing strategic thinking and key partnership thanks to an in-depth understanding of IT, Cloud and Hosting solutions.
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Applying it now to GDPR within the SGS in the Digital and Innovation Team. SGS is the world’s leading inspection, verification, testing and certification company.
Contact the COSUP
Whether you’re exploring adherence, have a question about the CR.GDPR Code of Conduct, or would like to learn more about the scheme, the COSUP team is here to help.
Get in touch using the details below, and a member of the Committee will respond to your enquiry as soon as possible.
