Meet the EUCROF26 Speakers

Experts coming together to share critical insights

EUCROF26 brings together leading industry experts to deliver an extensive array of presentations, expert panel discussions, and breakout sessions. Speakers will share their vast knowledge and experiences on the multifaceted nature of clinical research, covering essential topics such as regulatory changes, clinical trial technologies, quality assurance, data management, and patient-centric approaches.

Keynote Speaker

Emer Cooke

Executive Director
European Medicines Agency

Emer Cooke has been the Executive Director of the European Medicines Agency, based in Amsterdam, since November 2020. She also holds the role of Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA). Between November 2016 and November 2020, she was the Director responsible for all medical product related regulatory activities at the World Health Organisation in Geneva.

Ms. Cooke is a pharmacist with Master’s degrees in Science and Business Administration from Trinity College Dublin. She has over 30 years’ experience in international regulatory affairs and held management positions at the EMA as Head of Inspections and Head of International Affairs respectively from 2002 until 2016.

Learn more about Emer

She has also worked in the Pharmaceuticals unit of the European Commission, where intra-alia, she was responsible for international collaboration, EU enlargement and the orphan medicines regulation for the European Pharmaceutical Industry Association (EFPIA) and in various industry and regulatory positions in Ireland.

In 2021 she received the Muckross (her alma mater) Woman of the Year award. In 2022 she received European Movement Ireland’s “European of the Year” award. In 2023 she was awarded an honorary doctorate by the Royal College of Surgeons Ireland (RCSI) University of Medicines and Health Sciences. Most recently, in 2025, Ms Cooke was inducted as a Fellow of DIA and was awarded DIA’s highest honour – the ‘2025 Award for Outstanding Contribution to Health’.

Plenary Session Speakers

Peter Arlett

Head of Data Analytics and Methods Taskforce
European Medicines Agency

Learn more about Peter

Peter Arlett is Head of the Data Analytics and Methods Taskforce at the European Medicines Agency. In this role he leads on operations and transformation on clinical evidence at the EMA including clinical trials, real world evidence, safety reporting and data science including AI. He is Chair of the EMA Data Board, Co-Chair of the HMA-EMA Network Data Steering Group, Co-chair of the EMA AI Coordination Group, Co-chair of the Vaccine Monitoring Platform Steering Group, and Member of the ACT EU Steering Group. Prior to taking up this role in 2020, he held leadership roles within the EMA in the areas of pharmacovigilance, epidemiology, and risk management.

Prior to starting at EMA in 2008, Peter worked on new legislation and international collaboration for the European Commission, was the UK delegate to the European Committee for Human Medicinal Products, and was an assessor and manager at the UK’s MHRA. He has a medical degree from University College London, and began his career as a hospital physician in Oxford and London.

In addition to his role at EMA, Peter is Honorary Professor at the London School of Hygiene and Tropical Medicine. He is also a Fellow of the Royal College of Physicians of Edinburgh and of the Faculty of Pharmaceutical Medicines of London.

Estrella Garcia, PhD

Executive Director Global Clinical Operations
Almirall, S.A.

Learn more about Estrella

Estrella began her ‘scientific odyssey’ at the University of Navarra, Spain, where she gained a PhD in Genetic Toxicology. Following this, Estrella held at post-doctoral position at ICI (now Astra Zeneca) in Macclesfield, UK. At ICI Estrella’s focus was on novel anti-tumor drugs in the pre-clinical phase. Subsequently Estrella returned to Spain where she joined Almirall as a Clinical Research Scientist. Since then, Estrella has amassed a 32-year career with the company- taking on roles of increasing demand and responsibility, including Head of Allergy Therapeutic Area and Head of Clinical Development Operations- to the role she holds today.

Estrella leads her group and is responsible for clinical trials worldwide. Since Almirall do not have affiliates fully involved in clinical development, the company externalizes all clinical trials, with a strategic focus on keeping only core competencies- particularly for pivotal studies- in-house. In this capacity Estrella has worked with dozens of CROs and service providers managing Phase I to Phase IV clinical trials of all sizes, from small unicentric studies to global programs involving hundreds of sites and thousands of patients. Her responsibility is covering the selecting, negotiation, contracting, managing and final evaluation of the CROs responsible for the worldwide clinical development, to deliver on the agreed timelines, quality and cost.

Now fully focus on Dermatology development, managing trials worldwide mainly in Psoriasis, Acné, Atopic Dermatitis, Actinic Keratosis, among other indications. Always with the patients in the core of everything I do.

Proud of having participating in the main development products of Almirall, already in the market, among others Almogran® (first antimigraine product approved by FDA, and develop by Almirall), Skilarence® (psoriasis oral treatment), Ilumetri® (psoriasis biologic treatment), Klysiry ® (actinic keratosis topical treatment), Ebglyss® (atopic dermatitis biologic treatment).

Dipak Kalra

President
The European Institute for Innovation through Health Data (i~HD)

Learn more about Dipak

European Institute for Innovation through Health Data (www.i-hd.eu), a Professor of Health Informatics and a former London general practitioner. He plays a leading international role in Electronic Health Record R&D, including the reuse of EHRs for research. He has led the development of ISO standards on EHR interoperability, personal health records and data protection. He participates in multiple European Commission funded projects including the generation of real-world evidence in pregnancy, support for the accelerated uptake of digital health innovations, scaling up the quality, interoperability and the reuse of health data for research including inputs to the European Health Data Space, scaling up of the collection and use of health outcomes towards more value-based care, the development of an AI-powered federated learning platform in lung cancer and initiatives to improve a patient’s understanding of of their medication to improve confidence and adherence.

Zoltán Magyarics

Vice President, Research and Development
AOP Health

Learn more about Zoltán

Zoltán Magyarics has obtained his MD degree and completed his PhD in dendritic cell biology at the University of Debrece, Hungary. After a brief academic tenure at the same university, he subsequently started his preclinical discovery and development career at Intercell (currently Valneva) in Vienna, working on multiple antibacterial vaccines across various phases of development. He was later a founding member of the scientific team at Arsanis, a start-up biotechnology company located in Vienna, Austria and Boston, MA, focusing on developing monoclonal antibody therapies against bacterial and viral infections. Following preclinical discovery and development, he moved to clinical development in 2014 with Arsanis and worked both on the sponsor side as medical director for multiple European and US-based biotechs, as well as, in a global clinical trial feasibility and medical advis ory role at PSI CRO. After his latest role as Vice President of Development at Leyden Laboratories, he is currently the Vice President of Research and Development at AOP Orphan Pharmaceuticals, a Vienna-based global rare disease and specialty care pharma company.

Jens Peters

Head of Clinical Research
BPI German Pharmaceutical Industry Association

Learn more about Jens

Prof. Dr. Jens Peters studied veterinary medicine and pharmacy, has been active in clinical research for 20 years, and has been with the BPI German Pharmaceutical Industry Association since 2012. He heads the Clinical Research and Veterinary Pharmaceuticals business units and is also active in the research and pediatric pharmaceuticals care sectors. He holds a professorship for clinical research at the Medical School Hamburg (MSH) and is also a lecturer at the Technical University of Berlin in the master’s program in Clinical Trial Management.

Bart Scheerder

Chairman
Dutch Clinical Research Foundation

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Bart Scheerder is Program Manager AI Ecosystem at the University Medical Center Groningen (UMCG) and Chairman of the Dutch Clinical Research Foundation (DCRF). At UMCG he leads the strategic development of an AI-ready hospital, driving initiatives such as the AI Factory Groningen and other national initiatives to accelerate the safe and large-scale adoption of generative AI in healthcare. Through the DCRF he unites industry, academia, regulators, and patient organizations to strengthen the clinical research landscape in the Netherlands and Europe. His work focuses on translating emerging AI capabilities into clinical practice and ensuring robust governance, compliance, and public-private collaboration to bring innovative therapies to patients faster.

Claire Skentelbery

Director General
EuropaBio

Learn more about Claire

Claire holds a PhD in biochemistry and has led organisations that champion and advocate for commercial delivery of science for 25 years, starting within the Cambridge UK biotechnology cluster. She started her work to support biotechnology across sectors through the Council of European BioRegions and the European Biotechnology Network, before moving to the Nanotechnology Industries Association. She joined EuropaBio in 2020 and in addition to her current role as Director General, she is also the Chair of the International Council of Biotechnology Associations (ICBA) and a Governing Board Member for the Innovative Health Initiative (IHI).

Chris Smyth

Group CEO
Comac Medical

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Dr. Chris Smyth is Group Chief Executive Officer of Comac Medical. Dr. Smyth has over 30 years of executive leadership in global clinical research with a focus on biotech. Based in the UK, he brings deep expertise in driving innovation and operational excellence across international organizations. At Comac Medical, he leads the company’s strategic direction, expansion, and integration of specialist capabilities. Prior to Comac Medical, he was President of ICON Biotech and before that, President of IQVIA Biotech. Dr. Smyth also previously led global clinical operations for 8 years at an oncology biotech company, Antisoma. Dr. Smyth holds a Bachelor of Science degree in Biochemistry from the University of Kent at Canterbury, a PhD in Reproductive Biology from the University of Edinburgh Medical School, and an MBA from Henley Management College.

Karin Tulzer

Director, Sr. Quality Strategy Development Unit Lead
Merck Healthcare KGaA

Learn more about Karin

Karin Tulzer, is a highly experienced professional in the field of quality and risk management within the biopharmaceutical industry. She graduated with a Master’s degree in Food and Biotechnology from the University of Agricultural Sciences in Vienna, Austria. With over two decades of extensive experience, she currently serves as the Director of R&D Quality and Risk Management at Merck KGaA, where she leads strategic quality initiatives in the Neurology & Immunology sectors and globally.

Karin has a robust background in clinical operations, project management, audit and compliance management, risk assessment, and quality governance, having held various leadership roles at Merck and Eli Lilly, whereas she started her career in a collaborative study group for Oncology. Her expertise encompasses GCP, regulatory compliance, inspection readiness, and cross-functional collaboration, making her a key contributor to several high-stakes projects and initiatives.

In addition to her professional achievements, Karin is an advocate for staff development and mentorship, emphasising the importance of empowering her team and fostering a culture of excellence in quality assurance.

Breakout Session Speakers

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Jazmin Aguado-Sierra

Elem Biotech