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eucrof24 programme committee

Dagmar Chase (Co-Chair)
GCP Consultant and Trainer | Clinrex

Dagmar Chase earned a master’s degree in Computer Science (secondary focus on Theoretical Medicine) from the Technical University in Munich and holds a doctorate in Human Biology from the Medical Faculty in Ulm, Germany.

Dagmar Chase co-founded, together with Prof. Dr. Albrecht Neiss, the company GMI, a full service CRO for clinical trials phase II – IV, in 1983.
Besides developing GMI into one of the largest CROs in Germany, Dagmar Chase concentrated on Quality Management as well as the development of training programs for the pharmaceutical industry.

After selling GMI to Kendle in 1997, she worked on global development programs, being a vice-president at Kendle. In 2004, Dagmar started up Clinrex, a consultancy firm for clinical research. Besides providing training, she offers services covering all aspects of GCP and Quality Management in clinical trials, e.g., GCP gap analyses, SOP development, audits and inspection readiness programs.

Dagmar Chase is a co-founder of the German CRO association BVMA (Bundesverband Medizinischer Auftragsinstitute e.V.), which was established in 1991. She was the president of the BVMA from 2001 until the end of 2017 and is now an honorary member of the BVMA. Dr. Chase is also a co-founder of EUCROF, the European CRO Federation, and held the position of vice-president for 10 years until the end of 2016. She still chairs the EUCROF Clinical Trials Legislation Working Group and represents EUCROF at numerous EMA stakeholder meetings.

After many years of fruitful cooperation with the BPI (Bundesverband der Pharmazeutischen Industrie e.V.), Dagmar Chase was nominated “BPI Senior Expert” in 2019 in recognition of her knowledge and expertise in clinical research and GCP.

Benedikt Van Nieuwenhove (Co-Chair)
Founder | ECCRT

After Benedikt obtained his degree in Pharmaceutical Sciences, he worked as a quality assurance manager at a laboratory for medical biochemistry & clinical analysis in Gent from 1991 to 1997. From 1997 to 2014, he worked for Harrison Clinical Research. He continued his career as a clinical operations manager and general manager of the Benelux operations. In 2000, he founded a training academy called the “European Centre for Clinical Research Training” (ECCRT) and in 2007 he became a member of the Board. From 2008 to 2011, he acted as the Vice President Global Operations of the Harrison Clinical Research group. In January 2011, he was elected Chief Executive Officer of Harrison Clinical Research. In that position, he was involved in the merger with Synteract to form SynteractHCR. He was instrumental in integrating the two organisations during 2013 and 2014. Since its creation in 2000, Benedikt has been the Managing Director of ECCRT. Having been in the field of Clinical Research for about three decades he has amassed a wealth of knowledge and skills within this field. Over the years he has supported the Pharma Industry as well as other players in the healthcare sector by providing them with the skill sets to deal with the challenges in their jobs and by helping make them more effective in their respective careers. Since 204 he has been Vice President and President of the Belgian Association of CROs (BeCRO). Since 2016, he has been lecturing “Management of Clinical Research” at the Faculty of Pharmaceutical Sciences, University Ghent and managing at the ECCRT.

Martine Dehlinger-Kremer
Vice President of Scientific Affairs, Pediatric Subject Matter Expert, Drug Development Solutions | ICON PLC & President | EUCROF | EUCROF & ICON plc

Dr. Dehlinger-Kremer’s expertise spans more than 30 years in the research industry, including 30 years of experience in global regulatory affairs, medical affairs, and pediatric leadership. Prior to joining ICON, she served in several executive leadership roles at global CROs, and has experience in global drug development in more than 40 countries. She has contributed to the global development of numerous products, including medicines for children, drugs for orphan diseases and biosimilars. Her vision and leadership extend to service with a number of professional organizations – she is an observer member of the Coordinating Group of the European Network of Pediatric Research (Enpr-EMA) at the European Medicines Agency, President of the European CRO Federation (EUCROF) and chair of its Pediatric Working Group, serves as chair of the European Forum for Good Clinical Practice (EFGCP) Children’s Medicines Working Party and Board Member of the association, and is active in the International Children’s Advisory Network (iCAN).

In 2015, Dr. Dehlinger-Kremer was named one of PharmaVOICE’s 100 Most Inspiring People in Life Sciences. Dr. Dehlinger-Kremer earned a Doctorate in Sciences from the J. W. Goethe University in Francfort on the Main, Germany; a Diploma of Advanced Study in Neurophysiology from the University Louis-Pasteur, Strasbourg, France; and a Master of Sciences degree from University Moulin de la Housse in Reims, France.

Alan Yeomans
Regulatory Affairs Manager | Viedoc Technologies

Alan Yeomans has worked with the development of computerised systems for 40 years as hardware designer, programmer, system architect, project manager and in several management roles including CTO, Quality Manager and Regulatory Affairs Manager.

Alan was Quality Manager for Viedoc Technologies from late 2008 until March 2023, since then he has the role of Regulatory Affairs Manager. Alan has earlier worked as CTO for a Swedish CRO (CDC) and as CTO and QM for an international ePRO provider (Clinitrac).

Alan graduated with a Bachelor of Engineering (Electronics) from the University of Western Australia in 1980 and studied Control Systems at the Imperial College (London) in 1983.
Alan worked at British Aerospace, Space and Communications Division from 1981 to 1984 as a hardware designer on control systems for communications satellites. While there he developed the first CPU-board used in control systems on their communications satellites.

After moving to Sweden in 1984 Alan started working with software development, starting with hardware driver routines and moving up through the software architecture to all levels, including user interface software and database software.

Alan has worked with the use of electronic data in clinical research since the year 2000, and he has worked in the following international groups aimed at promoting the use of electronic data for clinical research:
• EHRCR Project – EU Team Leader (internal eClinical Forum project)
• EHR4CR Project – Member of User Scenario Task Team (EU project)
• eSource Task Group – Technical Stream Team Leader (internal eClinical Forum project)
• REG – Regulatory Expert Group – Co-chairman (internal eClinical Forum project)
• NTWG – New Technologies Working Group – Chairperson (internal EUCROF work group)
• eDigital Team – member (internal ACDM group)

Alan is a member of RQA (the Research Quality Association), eCF (the eClinical Forum), EUCROF (the EU CRO Federation) and ACDM (the Association for Clinical Data Management).

Antonio Torres
Senior Manager Medical Writing | ICON PLC

Antonio Torres is Senior Medical Writing Manager in ICON PLC. Antonio has over 20 years of experience on clinical research in CROs. Prior to joining ICON, he was the Head of Medical Writing Department for 17 years, providing writing, review, editing and QC of any research documents, including proposals, concepts sheets, protocols, CSR, informed consent forms, manuscripts, clinical development plans and analysis plans. He provided methodological advice, scientific guidance and expertise leading to the customer with an in-depth knowledge in clinical research study design (interventional and RWE studies).

At ICON PLC is responsible of Regulatory Writing of aggregated documents, in different programs of drug development and Subject Matter Expert on protocols and Clinical Study Reports. Antonio is part of the Spanish Society of Medical Oncology, member of the Program Committee of EuCROF and teacher of the Permanent Training Clinical Trial Master from the Universisity San Pablo CEU. Antonio has collaborated in artificial intelligence projects and is chair for the Artificial Intelligence Workstream of the congress about Pharmacovigilance and Medical Writing.

Goran Vesov
Owner and Managing Director | CRest Consulting

Dr. Goran Vesov, MD is a drug development professional with 20+ years of international experience – in big pharma, multinational CRO and as freelancer. He is currently owning and managing CResT Consulting. a clinical research quality and training consultancy, providing services to pharmaceutical companies and CROs alike.

His expertise encompasses:

• Thorough knowledge of ICH GCP and its current developments
• Experience in onboarding and advanced training of Clinical Research professionals (Sponsor, CRO and Site staff)
• Proficiency in development and implementation/follow-up of GCP Inspection readiness programs
• GCP Auditing of Clinical Investigational Sites
• Profound understanding and experience in Quality Assurance (e.g., development and update of Quality Management Systems)
• Clinical Research process improvement
• Medical Doctor degree, specialized in pediatrics and Master of science degree in pediatric endocrinology and genetics.

Goran is a member of the Events and Training Working Group (ETWG) of the European CRO Federation (EUCROF).

Jana Brajdih Čendak
Medical and Pharmacovigilance Lead | Billev Pharma East

Jana started her professional career as a practicing physician, specializing in Emergency Medicine. After almost 10 years in clinical practice, she joined Sanofi’s Medical Affairs team, covering Southeast and Central European countries. Following a short transition to Novo Nordisk, she moved to Billev Pharma East, a consultancy company based in Slovenia. In her current position, Jana is responsible for a team of pharmacovigilance specialists, medical advisors, and veterinary medical advisors, covering human and veterinary pharmacovigilance and providing medical regulatory support to clients.

She is currently more involved in toxicology, finalizing an MSc program in Toxicology at the Vienna Medical University and in the process of obtaining the European Registered Toxicologist certification. She is also an active member of various industry associations, including EUCROF and Medicines for Europe.

Martin O’Kane
Regional Head, Regulatory Affairs EU Policy & Liaison | Novartis

Martin O’Kane PhD is Regional Head of Regulatory Affairs EU Policy & Liaison at Novartis Pharmaceuticals, re-sponsible for developing and implementing complex regulatory strategies in global development and enabling regulatory compliance. He is co-chair of the European Federation of Pharmaceutical Industries Associations (EFPIA) EU Clinical Trials Regulation Pillar.

Martin has seventeen years’ previous experience in medicines regulation working in the Medicines and Healthcare products Regulatory Agency (MHRA), the majority of which was in the clinical trials field including scientific assessment of trial applications and development of policy, guidance, and legislation relevant to the UK’s exit from the EU and the UK response to COVID-19. Prior to Brexit, he was a member of Heads of Medicines Agencies Clinical Trials Facilitation Group (CTFG) developing policy to harmonise trial processes and conduct throughout the EU and also EMA and European Commission expert groups on the implementation the EU CTR the clinical trials information system (CTIS).

Alexandre Malouvier
Senior Director Scientific Affairs & Digital Innovation | ICON

Alexandre Malouvier, PhD, MS, Senior Director Scientific Affairs & Digital Innovation, eClinical Delivery and Development, has 25 years of clinical research experience, the majority of which focused on real-world research and digital health. Dr. Malouvier holds a Ph.D. in Human Physiology, a Diploma of Statistics Applied to Clinical Research, and a Diploma in Bone Pathology from the University Paris VII-Denis Diderot, Paris, France. He also holds a Master in Bioengineering from the Universities of Rheims, France.

Dr. Malouvier initially worked as a Research Scientist for the American and European Space agencies and then moved into the pharmaceutical industry, working as an international CRA in a small pharmaceutical company specializing in oncology, where he gained experience coordinating study activities. He was promoted to Project Manager and then Senior Director, positions he held at both CROs and major pharmaceutical companies.

In the past 20 years, Dr. Malouvier has specialized in late stage/real world research, spending the last 19 years in departments or companies fully dedicated to peri- and post-approval programs. These included Compassionate-Use Programs (Expanded Access Programs, Named-Patient Programs), Post-Marketing Authorization Safety Studies (PASS), Post-Authorization Efficacy Studies (PAES), Drug-Utilization Studies (DUS) an many other observational research programs. Alexandre managed different types of registries, including drug registries and natural history of disease registries. He finally moved in his current position 7 year ago where he works collaboratively with clients and internal ICON stakeholders to provide strategic direction for patient service innovation across the company, focusing on Decentralized Clinical Trials (DCT), CRAACO, digital endpoints, and access to patient data.
His previous roles leading project management offices in late phase research organizations has given him wide exposure to real world research from both the CRO and large pharma perspective and has cultivated his in-depth expertise. Dr Malouvier frequently authors white papers, makes presentations in professional forums and is part of organizing committees of multiple conferences.

Dr Malouvier is an active member of the Real-World Evidence Working Group of AFCROs (French association of CROs), the leader of AFCROs’s Global Resourcing Working Group, the leader of EUCROF’s Real World Data and Digital Health Working Group, and a former member of the Decentralized Clinical Trails Working Group of the ACRO.

Dr Malouvier is a member of the Scientific Board of the University of Paris’s Fundamental Sciences and Biomedicine Faculty where he teaches clinical research. He is the co-creator of four courses, one for Clinical Research Associates, another for Medical Science Liaisons, a Master Degree in Clinical Research and Translational Medicine and another Master

Darina Hrdlickova
Consultant and Investigator | Journeys to Better Therapy

Darina is a physician-psychiatrist by background with more than 30 years of experience in clinical research. She started as a psychiatrist and investigator in clinical trials at the Psychiatric Center Prague. In 1995 she became the founding member of the PPD office in the Czech Republic. During her 28 years of service she held various positions in the company, particularly in project and clinical operations management. In the years 2008-2023 she served as the Country Head for the Czech and Slovak republics, leading, representing and growing PPD clinical operations in these countries. Currently she is an independent consultant.
Darina is a founding member of ACRO-CZ and currently chairs this association. Start of her work in EUCROF dates back to 2010. She has lead the Conference Organising Committee of the 3rd-6th conference.

Fiona Maini
Senior Director, Global Compliance and Strategy | Medidata Solutions a Dassault Systèmes Company

Fiona has worked within the Life Sciences and Healthcare domain for over 24 years working across all GXP areas. Her focus at Medidata includes strategy and advocacy pertaining to the interface of technological advances and regulatory evolution in clinical research. In this role Fiona regularly interacts with authorities and industry bodies on modern technology strategies in particular patient centric technologies. Fiona also chairs the EUCROF New Technologies group and ACRO DCT Working Party.

Prior to Medidata Fiona was a Director at Deloitte, where she led the Deloitte Global Centre for Regulatory Excellence for Life Sciences and provided governance of Deloitte services to the European Medicines Agency and their programmes. Fiona has a BSc and Msc in Chemistry.