2 November 2021 - Personalised medicine

The EUCROF Events & Training Working Group is pleased to present the Training, which can be attended virtually, on

Personalised Medicine
Current Applications in Clinical Research 
and Regulatory Framework

Date & Time: 2 November 2021 from 9:00 AM to 15:30 PM (CET)

Attendees: Medical Directors, Senior Researchers, Project Managers, Investigators, Biostatisticians, Regulatory Experts, Scientific Societies and Patients Associations and any other person interested in Personalised Medicines Applications in Clinical Research.
€ 225 (for EUCROF members € 150) 

For further information , kindly write a message to
Ms Assia Rosati (This email address is being protected from spambots. You need JavaScript enabled to view it.).
09:00 – 09:20 Introductory Remarks Donato Bonifazi (Chair of EUCROF Events & Training Working Group)
Session I: An overview and the current applications of personalised medicine
09:20 – 10:00 Personalised medicine current applications and the future: adults and paediatric case studies. Oscar Della Pasqua (TEDDY European Network of Excellence for Paediatric Research, UK)
10:00 – 10:40 Personalised medicine and pharmacokinetic modelling and simulation in paediatric and adult population Youssef Daali (Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals, Switzerland)
10:40 – 10:50 Break  
Session II: The use of biomarkers in personalised medicine
10:50 – 11:30 The application of biomarkers to improve patient outcomes and their validation Antonia Vlahou (Biomedical Research Foundation, Academy of Athens, Greece)
11:30 – 12:10 STATs transcriptional networks: Towards paediatric and adult biomarkers discovery"  Eleni Katsantoni (Biomedical Research Foundation, Academy of Athens, Greece)
12:10 – 12:40 Lunch break  
Session III: Clinical trial design and implementation
12:40 – 13:20 Pharmacogenetics and pharmacogenomics: their impact on personalised medicine and implementation into clinical practice. Marius Geantă (Center for Innovation in Medicine, Romania)
13:20 – 14:00 Clinical trial objectives, methodology and design in the era of precision medicine Paola Baiardi (Istituti Clinici Scientifici Maugeri Spa Società Benefit, Italy)
14:00 – 14:10 Break  
Session IV: European Regulatory Environment
14:10 – 14:50 Future perspective of personalised medicine within the regulatory framework Ulrich Granzer (Granzer Regulatory Consulting & Services, Germany)
14:50 – 15:30 Ethical challenges of personalised medicine Ma'n H. Zawati (Executive Director of the Centre of Genomics and Policy, McGill University, Quebec, Canada)


Youssef Daali

Youssef Daali

Professor at Faculty of Medicine of Geneva University

Youssef Daali is a Professor at Faculty of Medicine of Geneva University and Head of the Laboratory of the Clinical Pharmacology and Toxicology Service at Geneva University Hospitals. Youssef completed his doctorate in Pharmaceutical Sciences at the School of Pharmacy of Geneva University in 2001. He joined the Clinical Pharmacology Service at Geneva University Hospitals in 2002. Prof Daali is also a senior lecturer at School of Pharmacy. The research activities of Prof Daali are related to personalized medicine with specific interest for drug metabolism, pharmacokinetics and PBPK. Youssef also developed several in vitro models for drugs metabolism and transport characterization and drug-drug interaction studies. Prof Daali has an internationally recognized competence in bioanalysis for drugs and metabolites determination using liquid chromatography mass spectrometry. One of the recent research projects of the group is devoted to the use of PBPK simulation approach for dose adjustment to avoid drug-drug interactions in clinical setting. Prof Daali also conducted a number of clinical trials, related to drug metabolism, pharmacokinetics and drug-drug interactions. The scientific contribution of Prof Daali has been awarded in several national and international meetings. He is also member of several national and international societies in the field of pharmacology, bioanalysis and toxicology. He published more than 130 papers in the most important peer-reviewed journals of clinical pharmacology and bioanalysis and has an index H of 32.

Ulrich Granzer, PhD

Ulrich Granzer, PhD

Founder of Granzer Regulatory Consulting & Services

Ulrich Granzer, PhD. is working as an independent consultant for drug development and regulatory affairs. In January 2002, he set up his own consultancy company with currently 40 employees. He and his company are focusing on all aspects of drug development and regulatory affairs with a special consideration of orphan drugs. Ulrich Granzer has major experience in the development and regulatory affairs of biotech products and small molecules including orphan products. After finishing his PhD in pharmaceutical chemistry Ulrich Granzer started his industry career at Glaxo where he held the position head of regulatory affairs. After leaving Glaxo Wellcome he joined BASF pharma Knoll, where he took over responsibility as Vice President global regulatory centers, which comprised regulatory affairs, drug safety, and GXP. At Knoll he worked on the development of several biological compounds directed against the sequelae of stroke, septic shock, and rheumatoid arthritis, where he had major involvement into the program for the first fully human anti TNF antibody, now marketed as Humira. After Knoll was taken over by Abbott, he joined Bayer as VP, global regulatory affairs, where he stayed until he founded his own company. He has a track record of working on more than 250 new molecular entities (small molecules, proteins, antibodies, oligonucleotides). He and his company have performed more than 300 orphan drug designations in the US and EU and they are involved in more than 300 scientific advice meetings with EMA, FDA and other regulatory authorities every year. Furthermore, they prepare and file BLAs, NDAs, and MAAs and are involved in an average of 10-15 approvals for new molecular entities every year.

Marius Geanta, MD
President and Co-Founder
Center for Innovation in Medicine

Marius Geantӑ, MD

President and Co-Founder Center for Innovation in Medicine

Marius Geantă is President and Co-Founder of the Center for Innovation in Medicine, a non-governmental organisation based in Bucharest, Romania, focused on innovation in the healthcare sector. The aim of the Center for Innovation in Medicine is to shorten the time between the emergence of innovations in the medical sector and their application so that they can benefit patients both in Romania and elsewhere. In the context of Romanian Presidency of EU Council 2019, The Center for Innovation in Medicine proposed the vision paper “A new vision for cancer in Europe: data, technology and human touch” to be included in the EU Beating Cancer Plan. Marius is a pioneer in the field of personalised medicine in Romania and Central Eastern Europe and is involved in some pan-European innovative healthcare projects, such as Information Technology: The Future of Cancer Treatment, DigiTwins Consortium, International Consortium for Personalised Medicine, Public Health Genomics Network, PECAN, Building Blocks for Personalised Medicine. As President of the Centre for Innovation in Medicine, Marius is the coordinator of “State of Innovation in Medicine” Annual Report and the organiser of the high-level events Science meets Politicians (in partnership with Romanian Parliament) and Personalised Medicine Conference (two editions in partnership with Romanian Presidential Administration).



Eleni Katsantoni, Investigator C

Eleni Katsantoni, Investigator C

Biomedical Research Foundation, Academy of Athens


Eleni Katsantoni received her degree in Biology from the University of Athens, Greece (1995), Master of Science in Medical Genetics from the University of Newcastle, UK (1996) and PhD in Molecular Biology and Biomedicine from the University of Crete, Greece (2002). Her PhD research focused on investigation of the molecular mechanisms of globin genes transcriptional regulation and hemoglobin switching. For the period 1999-2005 she has worked in the Department of Cell Biology, Erasmus Medical Center, Rotterdam, Netherlands, initially as a visiting PhD student and then as a postdoctoral fellow, funded by a Marie Curie post-doctoral fellowship (EU). Her post-doctoral work focused on understanding the role of erythropoietic transcription factors in erythroid differentiation by characterization of transcription factor complexes and target genes. She developed inducible systems in transgenic mice and bioinformatics tools for analysis of target genes networks. In May 2005 she returned in Greece, supported by a Marie Curie European Reintegration Grant (EU) and since then she is working as Group leader in BRFAA. Her research focuses on mechanisms of transcriptional activation and repression mediated by Signal Transducers and Activators of Transcription (STATs). Her lab is trying to understand how the interactions of STATs with other factors influence gene transcription and how target genes networks are co-regulated in normal or ineffective erythropoiesis, and in leukemia. Her lab uses various omics approaches and her projects are funded by EU (FP6, FP7, Horizon 2020), Research Promotion Foundation (Cyprus) and General Secretariat for Research & Development and Ministry of Education (Greece) .




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