Mariagrazia Felisi currently serves as Clinical Projects Director and ICH-GCP Auditor at CVBF, where she contributes to the company’s projects, ensuring adherence to high-quality standards. She is a member of the Board of Directors of TEDDY, the European Network of Excellence for Paediatric Research, and serves as its Chair.

She earned a Master’s Degree in Life Sciences, followed by a PhD in Clinical Pharmacology from the University of Bari in 2002 and a Master’s Degree in Pharmacovigilance from the University of Florence in 2003.

Mariagrazia has conducted extensive research in the paediatric field, with a focus on clinical pharmacology, pharmacovigilance, and the management of disease registries. These experiences have enabled her to acquire deep knowledge and expertise in clinical research. She has been involved in numerous national and international research projects, often taking on leadership roles in clinical trial activities.

Aida Loshaj Shala is an Assistant Professor at the Department of Pharmacy, Faculty of Medicine, University of Prishtina. She studied Pharmacy at the University of Prishtina, Kosovo, and conducted her PhD research at the Faculty of Pharmacy, University of Skopje, Northern Macedonia.

She holds a certification in Quality Control of Medicines and was a part of the team that established the Laboratory for Quality Control of Medicines at Kosovo’s Agency for Medicines and Medical Devices, building it from scratch, and served as its director.

Aida has participated in several specialized training programs and courses on the demarcation between medicinal products, medicinal devices, dietary supplements, and cosmetic products, also with BfArM. She also participated in the training program for harmonization of legislation for medicinal products for human and veterinary use organized from the European Agency of Medicines (EMA).

Aida teaches courses in Quality Control of Medicines, Basics of Pharmaceutical Technology, and Toxicology. She has published several peer-reviewed papers, contributing to her field through both research and education.

Dr Anila Godo, Professor in pediatrics, has been head of the Pediatric Department at the Medical University of Tirana and head of Service of Oncology /Hematology, at the UHC “Mother Theresa” in Tirana for 28 years.

She has been elected twice as head of the Interhospital Commission and has been Vice Dean of the Faculty of Medicine of Tirana between 2002 and 2007, and head of its pediatric department for almost 15 years. She has been Minister of Health of Albania from 2008 to 2009.

Sha is titular of teaching program in hematological pediatric curriculum from 1990, and in oncological pediatric curriculum from 1995; Curriculum’s Compiler Graduate and Postgraduate Programs, for general, hematological and oncological pediatric area.

Now she is Vice Dean of the Italian private university of Medicine in Tirana “Università Madonna del Buon Consiglio”, and counselor for strategies and interinstitutional relationships for “Ospedale Cattolico Madonna di Buon Consiglio” at this university.

Sha has many publications, contributions and collaborations and sha is a member of TEDDY since 2017.

Dr Donato Bonifazi is an Economist specialised in European Project Management and Chief Executive Officer at CVBF, a non-profit research consortium with 25 years’ experience in health and pharmaceutical research. He is Chair of the Events & Training WG at EUCROF (European CRO Federation), Board Member at TEDDY – European Network of Excellence for Paediatric Research, Member of the Coordinating Group at Enpr-EMA, Member of the ACT EU multi-stakeholder platform Advisory Group, Member of the iCAN – International Children Advisory Network Advisory Group.

He has been project coordinator and trial manager of the multinational paediatric clinical trials EU-funded project DEEP – DEferiprone Evaluation in Paediatrics (FP7 GA 241683) and is involved in several projects aimed at enhancing research for paediatric and rare diseases patients like c4c and EJP RD, now ERDERA.

He is Coordinator of EPTRI (European Paediatric Translational Research Infrastructure) and of the OrphaDev4Kids project aimed to enhance technology-driven paediatric drug discovery and studies and to foster the development of paediatric medical devices for the treatment of children with rare diseases.

Fedele (Duccio) Bonifazi is the President and Head of the Data Science & IT Unit of the Fondazione per la ricerca farmacologica Gianni Benzi onlus , a non-for-profit scientific research organization that promotes biological, medical, and pharmaceutical research to support the development of innovative and safe health technologies in Europe, with a focus on children and rare disease patients. His background includes a master’s degree in bioengineering and a post-graduate master in HTA. orcid.org/0000-0003-4935-5702

Florentia Kaguelidou is a pediatrician and professor of Clinical Pharmacology at the Faculty of Medicine, Paris Cité University, Paris, France. She is the head of the Clinical Investigation Center, Inserm CIC1426 at the Robert Debré University Hospital, APHP and part of the research team URP7323, Perinatal and Pediatric Pharmacology and Therapeutic Assessment. Her research focuses on the methodology of clinical trials in pediatrics and the conduct of pediatric pharmacoepidemiology studies, with a special interest in the use and evaluation of the effects of psychotropic medications and analgesics in children.

Nunzio Denora earned his PhD in Pharmaceutical Technology from the University of Palermo in 2004. Following a postdoctoral fellowship at the Department of Pharmaceutical Chemistry at Kansas University, he was appointed as an Assistant Professor in 2006. His academic journey progressed, and in 2019, he was promoted to Associate Professor.

As of July 2023, he holds the position of Full Professor in Pharmaceutical Technology and Legislation at the University of Bari, where he leads a cutting-edge research laboratory focused on advanced drug delivery systems. Throughout his career, Professor Denora has authored over 206 peer-reviewed publications and is the inventor of 10 patents. He also serves as the Coordinator of the Industrial PhD program in “Sustainable Technologies for Medicines and Diagnostics Development” and plays an active role in shaping pharmaceutical education and research. He is member of the board of directors for the European Paediatric Translation Research Infrastructure – EPTRI and the co-leader of the thematic research platform in Paediatric Medicines Formulations.

In addition, he is the Secretary of the Italian Society of Pharmaceutical Technology and Legislation (SITELF). His research is at the forefront of pharmaceutical innovation, focusing on the development of advanced drug delivery systems using state-of-the-art technologies such as 3D printing, prilling, and microfluidics with a special emphasis on paediatric formulations.

Piotr Socha is graduated in Pediatrics, gastroenterology and transplantology. He works at the Children’s Memorial Health Institute (CMHI) in the Department of Gastroenterology, Hepatology, Nutritional Disorders & Pediatrics, he is Head of the Gastroenterology and Hepatology ward in CMHI since 2009 and Deputy Director for Research and Education of CMHI since 2017. He is the author and coauthor of more than 500 peer-reviewed papers.

Research and clinical work were mainly devoted to cholestatic liver disease, non-alcoholic fatty liver disease, rare metabolic liver diseases (e.g. Wilson disease, contributed to discoveries of new diseases e.g. PGM-1, V-ATPase deficiency), non-invasive markers of liver fibrosis, nutrition in hepatology and gastroenterology (e.g. LCPUFA deficiency), obesity prevention and therapy, feeding disorders, protracted diarrhea and inflammatory bowel disease of infancy and early childhood.

Giorgio Reggiardo is an expert statistician with extensive experience in epidemiology, biostatistics, multivariate analysis, Bayesian inference, meta-analysis, big data analytics, and clinical trial design, including randomized controlled trials, power calculations, survival analysis, and regression methodologies. Giorgio Reggiardo is the Biostatistic Head at TEDDY as well as a member of TEDDY Board of Directors. He coordinates the TEDDY Working Group on “Paediatric Research Methodologies” with a particular focus on conducting studies and clinical research in the paediatric population. This WP supports the TEDDY’s membership in several European Union and international initiatives, such as Accelerating Clinical Trials in the European Union (ACT EU), the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), and the Standard Protocol Items for ReportIng clinical Trials (SPIRIT-children)| Consolidated Standards of Reporting Trials (CONSORT) initiatives.

Giorgio has also contributed to the CDISC (Clinical Data Interchange Standards Consortium) in Italy and collaborates with SAS Institute. He is actively involved in the leadership of the CDISC Pediatric User Network. Additionally, he has co-authored the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials).  

Dr. Eleonora Passeri, PhD, is a neuroscientist by education and training, she is an expert in patient advocacy, rare diseases, science communication, and policy.  

She was the communication manager at the European Reference Network (ERN) ReCONNET, the European Joint Program on Rare Diseases (EJP RD) and the International Rare Diseases Research Consortium (IRDiRC); she was a communication consultant for the European Pediatric Translational Research Infrastructure (EPTRI) and CVBF, she also supported the patient advocacy initiatives carried on by TEDDY Network.  

In parallel, Dr. Passeri was a scientific expert for the European Union (EU) – REA program – and a Medical and Scientific Advisory Board of the Ghana Initiative for Rare Diseases as well as a healthcare professional expert at European Medicines Agency (EMA).  

Furthermore, she extended her advocacy, policy, and leadership skills by being i) the vice coordinator of Comitato Nazionale Malattie Rare (CoNaMR), National Rare Disease Committee instituted by the Italian Ministry of Health; ii) the founder of the “Rare Special Powers” (RSP) not-for-profit association focused on raising awareness of rare diseases and/or neurodevelopmental disorders; iii) a former member of the “Osservatorio sulla condizione delle persone con disabilità della Regione Umbria”. 

Moreover, Dr. Passeri is a member of the Cancer Understanding Prevention in Intellectual Disabilities (CUPID) European Cooperation in Science and Technology (COST) Action and was a former deputy leader for public awareness at COST Action Maximizing Impact of research in NeuroDevelopmental Disorders (MINDDS).  

Prof Oscar Della Pasqua is Chair in Clinical Pharmacology & Therapeutics at University College London, UK. He is also Senior Director of Clinical Pharmacology Modelling and Simulation at GlaxoSmithKline R&D and Associate Fellow at the National Research Council in Rome, Italy addition to his extensive experience in early and late clinical development, he leads a research group focused on biomarkers, disease modelling, and clinical trial design methodology. He has > 150 scientific publications in peer-reviewed journals and is Senior Editor of the British Journal of Clinical Pharmacology.   

Fiona Rako is a last year Economics student with a prospect of pursuing a master’s degree in health economics and healthcare management. She has been an active member of the KIDS Albania chapter since its beginning, by attending a lot of the summits and projects presented by TEDDY Network and its partners.
Since 2023, she is part of the TEDDY General Assembly and was also elected as its representative in the TEDDY Board of Directors.
Currently she is involved in the project proposal of “Patient-Centered Clinical Study Endpoints Derived Using Digital Health Technologies”.