Semmelweis Symposium 2021 is one of the most prestigious international scientific events of Semmelweis University and one of the most important forums for sharing the latest developments in scientific research. This year, Semmelweis Symposium 2021 is focusing on translational medicine with special emphasis on coronavirus disease, its therapy, and the late effects of the virus infection in the paediatric population.

Topics will be discussed by internationally renowned scientists and health professionals in various panel discussions and presentations.

Semmelweis University is strongly involved in EPTRI and is coordinating the establishment of the Hungarian node.

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EPTRI will be represented by Prof. Constantinos Deltas, University of Cyprus, whose poster “A Biobank is growing in Cyprus” has been selected for an oral presentation in the afternoon poster session.

The Center of Excellence in Biobanking and Biomedical Research aims to build the first Biobank in Cyprus, that will serve the practise of high-quality medical research. The first and major project is the preparation of the Cypriot Human Reference Genome. The biobank has been involved in Cypriot National Node of EPTRI, to which the University of Cyprus is one of the members, as it is important to guarantee access to paediatric samples through a well organised biobank with ethical and quality standards.

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During the meeting, EPTRI will be represented by Dr. Giovanni Migliaccio who will intervene in the panel discussion on the special need for paediatric infrastructure to enhance children’s access to ATMPs.

Considering that, due to their complex manufacturing and distribution processes, many of these therapies will be available only in a small number of treatment centres in Europe and so many patients in Europe may need to travel cross-border to benefit from treatment with a transformative therapy, the event will explore whether there is a need to adapt the current legislative framework to overcome the current access challenges to ATMPs and enable cross-border delivery and reimbursement of treatments.

The meeting programme is available here while you can register at this link.

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The series ‘A Journey in Paediatric Medical Devices: From Regulations to Clinical Case Studies and Patients Involvement’ is composed of three non-propaedeutic webinars that will deal with different aspects of the medical devices field: regulatory, clinical and developmental case studies, and patients involvement.

The first webinar ‘The evolution of the regulatory framework of MDs in Europe’ has been held on October 28th. It deepened in the general aspects on medical devices, absorption issues, the new requirements and changes compared to the older one and which are the specific needs to be covered according to the MDs Regulation to develop safer and adequate MDs for paediatric patients.

The second webinar ‘A magnifying glass in the world of the medical device development’ will be held on 25th of November 2021 at 11.00 CET. It is tailored to the development of medical devices and will cover different MDs fields through the presentation of case studies.

The third and final webinar ‘Health technology designed for children with children’ will be held on 16th of December 2021 at 15.00 CET. Versatility is key to the development of health technology for children and young people so that it is adaptive to their social, physical and developmental needs. Co-design and development of medical devices with children and young people is key to adoption, acceptance and trust. This webinar will focus on the patient involvement in MDs development.

For more information and registration visit the dedicated web pages.

The post EPTRI First Webinar Series: A JOURNEY IN PAEDIATRIC MEDICAL DEVICES first appeared on EPTRI.

• Identify the current state of the art for European research networks/infrastructures that can facilitate drug research in children.
• Describe two exemplars of the development of European research networks/infrastructures.
• Suggest the future state, the situation from 2024 onwards.

Paediatric drug development faces several barriers. These include fragmentation of stakeholders and inconsistent processes during the conduct of research. This review summaries recent efforts to overcome these barriers in Europe. Two exemplar initiatives are described. The European Paediatric Translational Research Infrastructure (EPTRI) facilitates preclinical research and other work that underpins clinical trials. conect4children (c4c) facilitates the design and implementation of clinical trials. Both these initiatives listen to the voices of children and their advocates. Coordination of research needs specific effort that supplements work on science, resources and the policy context.

Among the authors of this paper there are Dr. Donato Bonifazi, EPTRI Coordinator and Prof. Adriana Ceci, EPTRI Senior Scientist.

Read the article here.

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The first EPTRI webinar “Research in paediatric diseases: from nanotechnologies to diagnostics and precision medicine” held on September 28^th was organised in collaboration with the Italian National Research Council (CNR) and was devoted to the Italian medical and biomedical sciences students to increase the knowledge and stimulate their curiosity.

Experts from Italian CNR Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies (IBIOM) in Bari, Institute of Nanotechnology in Lecce (NANOTEC), Institute for Biomedical Research and Innovation in Palermo (IRIB) and Institute for Biomedical Technologies in Milan (ITB) with researchers from University of Palermo presented their work on different areas of paediatric research like mitochondria, neurodevelopmental disease, personalised medicine, innovative diagnostic approach, anticancer nanodrugs, rhinitis, machine learnings’ approaches, repurposing, and pulmonary diseases. The recording of the morning and afternoon session and the presentations are available here.

The second event “The biotech approach to paediatric medical devices” held on September 29^th was addressed to experts in the field and whoever wanted to improve its knowledge on medical devices. It provided an in depth overview of the challenges in paediatric medical device development like versatility, diversity, complexity, viability, misconception, scalability, transferability, and longevity, the importance of the networking to overcome the lack of targeted devices for children and of the involvement of children in MDs development. In addition, examples of smart devices with appealing interfaces, and a paediatric orthopaedic bioresorbable implants case study followed from bench to bedside were provided. The recording and the presentations are available at this link.

The last event “Paediatric formulations carrying biotech drugs: special focus on Covid-19 vaccines” held on October 1st was organised by the Department of Pharmacy – Drugs Science of the University of Bari “Aldo Moro” (UNIBA) and Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF), on behalf of EPTRI. The webinar detailed the state of the art of the paediatric formulation development and of COVID-19 vaccines, the related issues, the regulatory path for paediatric medicines and the status of development and authorisation of Covid-19 vaccines for paediatric use. The recording and the presentations are available at this link.

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The webinar will take place on the 1^st of October 2021 at 11.00 CEST and it will deal with the formulation and ethics aspects of development, administration, and authorisation of paediatric use of pharmaceutical nucleic acids’ products. A special focus is foreseen on the status of development and authorisation of Covid-19 vaccines for paediatric use.

The speakers of the webinar are Prof. Nunzio Denora, Professor of Pharmaceutical Technology and Drug Regulation at the Department of Pharmacy – Drugs Science, University of Bari “Aldo Moro”, and Dr. Viviana Giannuzzi, Head of the Research Department, Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus.

The registration is mandatory at the following link: https://forms.gle/3DiFiNbhc1NW4X768

Connection details will be shared with the participants after registering to this webinar.

Join the webinar and share it with your colleagues interested in paediatric formulations!

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It is a week full of events celebrating biotechnology to share and make awareness on this vast and heterogeneous field to underline the pivotal role in improving the quality of life.

The EPTRI webinar “The biotech approach to paediatric medical devices” will be held on the 29th of September at 15.00 CEST and will last one hour. It will explore the relationship between medical devices and biotechnology in the context of the needs of children and young people, with a case study on the challenge in developing resorbable implants for children and the need from the patients’ point of view.

The webinar speakers are Prof. Paul Dimitri, Professor of Child Health and Consultant in Paediatric endocrinology at Sheffield Children’s NHS Foundation Trust, and Prof. Annelie Weinberg, Professor of Orthopaedic and Trauma specialised in children’s trauma at University of Graz.

The webinar is addressed to researchers from academia and industries who deal with paediatric MDs challenges.

Join the webinar and share it with your colleagues interested in medical devices!

The registration is mandatory at this link: https://forms.gle/Ri6UGeT1XUpuZTr49

Connection details will be shared with the participants after registering to this webinar.

The Agenda of the webinar is:

15.00 CEST Convergent technologies in child health – Prof. Paul Dimitri

15.25 CEST Paediatric orthopedic trauma: bioresorbable implants from bench-bedside – Prof. Annelie Weinberg

15.40 CEST Questions&Answers

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We are pleased to inform you that EPTRI is participating in the IX Edition of the European Biotech Week that will take place from September 27 – October 3, 2021, a week full of events celebrating biotechnology!

The EPTRI’s events calendar foresees:

• On the 28th of September 2021 (10.00 – 17.30 CEST) the webinar “Research in paediatric diseases: from nanotechnologies to diagnostics and precision medicine” focusing on topics related to paediatric biotechnologies ranging from the role of mitochondria in the neurodevelopmental disease to multi-omics approaches and nanotechnologies applications in diagnostics and therapeutics; from proteomics to precision medicine and drug repurposing in respiratory diseases. It is organised by the Italian National Research Council and EPTRI and is addressed to Italian medical and biomedical sciences students. The webinar will be in Italian.
• On the 29th of September 2021 (15.00-16.00 CEST) the webinar “The biotech approach to paediatric medical devices” which will explore the relationship between medical devices and biotechnology in the context of the needs of children and young people, with a case study on the challenge in developing resorbable implants for children and the need from the patients’ point of view. It is addressed to experts in paediatric medical devices. The webinar will be in English.

On the 1st of October 2021 (11.00-12.00 CEST) the webinar “Paediatric formulations carrying biotech drugs: special focus on Covid-19 vaccines” focusing on the formulation and ethical aspects of development, administration, and authorisation of paediatric use of pharmaceutical nucleic acids’ products with a special focus on the status of development and authorisation of Covid-19 vaccines for paediatric use. The webinar is organised by the Department of Pharmacy – Drugs Science of the University of Bari “Aldo Moro“ and Consorzio per Valutazioni Biologiche e Farmacologiche on behalf of EPTRI. It is addressed to experts in paediatric formulations and vaccines. The webinar will be in English.

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