EUCROF25 Plenary and Keynote

Rainer Becker is Director for Medical Products and Innovation at the European Commission’s DG for Health and Food Safety. He is responsible for legislation and policies on human and veterinary medicines, medical devices and innovation. His directorate, amongst others, leads the Commission’s work on the revision of the EU pharmaceutical legislation, the availability of medicines, the targeted evaluation of the medical devices regulations and clinical trials. Prior to his current position, Rainer, amongst others, was in charge of antitrust enforcement in the area of pharmaceuticals and health in the Commission’s DG Competition.

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Dorte brings a wealth of outsourcing experience. Currently working as independent consultant in her own business supporting biotech and pharma companies on outsourcing, vendor relation, governance, outsourcing strategies etc. She has worked as Senior Category Manager at H. Lundbeck, where she worked in Clinical Development and Outsourcing functions for +27 years and in her present role for 10 years. Based in Copenhagen, Dorte is embedded within the gritty reality of addressing and resolving day-to-day outsourcing challenges and she brings great insight and pragmatic experience to the PCMG Training team. Through the many years at Lundbeck she has been responsible for influencing and actioning the outsourcing strategy within H Lundbeck and was instrumental in growing the team of outsourcing professionals with coaching and mentoring.

In PCMG training group Dorte is a dedicated trainer and has been part of the team who have established the training function within PCMG. Her specialist training areas include the Outsourcing Process, Relationship building, Performance Management, Governance and Oversight of service providers and Subcontracting.

Dorte has been a PCMG member since 2015.

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Dr Peter Arlett MD, FRCP, FFPM
Head of the Data Analytics and Methods Taskforce, European Medicines Agency (EMA).

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.

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Amelia Martín Uranga, PhD in Law, Director of Clinical and Traslational Research Department and Head of the Innovative Medicines Platform at Farmaindustria, focuses her work mainly on the implementation and management of public-private collaboration projects in the areas of clinical and traslational research, such as the Project BEST and the Farma-Biotech collaboration project. Her aim is to create, develop and strengthen an ecosystem for biomedical research to address patient needs in Spain.

Martín Uranga is also a member of the Research and Data Governance Working Groups of EFPIA (European Federation of Pharmaceutical Industries and Associations) and represents Farmaindustria in the R&D Commission of CEOE.
Her research has been carried out at the Inter-University Chair of Law and the Human Genome, where she collaborates. For over 20 years, she has been a regular speaker at numerous national and international conferences, seminars, and workshops and is the author of various publications on ethical, legal and biomedical research topics.

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Marianne Pilgaard is the Chief Executive Officer of Trial Nation, a public-private non-profit partnership dedicated to advancing clinical trials in Denmark. Trial Nation supports stakeholder engagement in clinical trial processes, strengthens clinical trial infrastructure and framework conditions, and aims to increase the number and quality of clinical trials and testing conducted in Denmark.

Before joining Trial Nation, Marianne spent over twenty years at Novo Nordisk, where she held strategic leadership roles spanning the entire value chain, with a focus on clinical research and innovation. During her tenure, she played a pivotal role in the Swelife initiative, Sweden’s national public-private strategic innovation program designed to strengthen life sciences and improve public health.

As a passionate advocate for advancing life sciences, Marianne facilitates and supports public-private collaborations and partnerships that drive innovation in clinical trials and supports a well-functioning life sciences eco-system.

Marianne holds a Master of Science in Chemistry and Biomedicine from Kalmar University and a CMI Level 7 Diploma in Strategic Management and Leadership, underscoring her robust scientific and executive credentials.

At this conference, Marianne Pilgaard will share her insights on fostering public-private partnerships to drive excellence in clinical trials, offering practical strategies for stakeholders to collaborate effectively and innovate for the future.

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2022-today: Clinical Trials Coordination Group (CTCG) Chair
2019-today: CTIS Member State Product Owner AGES MEA
2017-2022: Safety Assessor Clinical Trials AGES MEA
2015-2017: PRAC Alterate
2008-2017: Pharmacovigilance Assessor AGES MEA
2003-04: Doctor of Medicine University of Vienna

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Gabriele Schwarz, licensed pharmacist, has been employed at the Federal Institute for Drugs and Medical Devices (BfArM) since 2001. 

Since the beginning of 2023, she dedicates her expertise and resources to regulatory activities at European and international level. She currently represents the EU member states in the ICH E6(R3) Expert Working Group, which is drafting a revision of the GCP guideline. At the same time, she contributes to several Priority Actions of the Accelerating Clinical Trials in the EU (ACT EU) Initiative, a joint project of the Commission, the EMA and the Heads of Medicines Agencies, which aims to modernise the European framework conditions for clinical trials and better meet the needs of patients and trial participants.

Until the end of 2022, she was Head of the GCP Inspectorate at BfArM and her responsibilities entailed the planning, coordination and implementation of BfArM’s GCP inspection activities, mainly in the context of the European marketing authorisation procedures for medicinal products. 

From 2002 – 2022 she was also an appointed member of the GCP Inspectors Working Group (GCP IWG), which is hosted and chaired by the European Medicines Agency (EMA), and was actively involved in a high number of sub-groups and the development of regulatory guidelines.

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