The TEDDY General Assembly meeting began with a review of the 2023 activities. The discussion covered several key topics. On promoting children’s access to medicines, it was noted that TEDDY will continue updating the EPMD database and plans to include new data on pediatric medicines and orphan medicinal products. An action plan to address off-label use includes compiling good practices, conducting surveys, and selecting drugs for repurposing. Additionally, a survey on pediatric medical devices will be launched in collaboration with the EPTRI Medical Device Platform.

In the realm of pediatric research, TEDDY will remain active in ethical, legal, and regulatory discussions and will contribute with innovative methodologies for special needs. The organization will participate in collaborative projects and promote new European research initiatives.

Engagement with young patients stays a priority, with TEDDY working on disseminating the “Guide to Children’s Participation in Health Decisions” and managing the TEDDY KIDS Advisory Group. Plans include setting up more advisory groups and producing educational materials.

The meeting also addressed strategies for enhancing awareness among key stakeholders, including preparing campaigns and educational courses for young researchers and developing a sustainability plan.

The meeting concluded with the election of the new Board members, with M. Felisi elected as Chair. The TEDDY KIDS Advisory Group was also officially constituted with new members from the different KIDS groups under the TEDDY umbrella.

The TEDDY General Assembly 2022 was held at the Council of Europe, beginning with an introduction by Laurence Lwoff, Katrin Uerpmann, and Annagrazia Altavilla. A video on children’s participation in health decision-making was presented by Maria Cavallo and TEDDY Kids.

Empowerment activities included a training course for paediatric expert patients on rare diseases, presented by Roseline Favresse and Adriana Ceci, and the TEDDY “My CTC” serious game by Maria Cavallo. Begonya Nafria Escalera introduced the EPTRI toolkits for translational paediatric research, while Annagrazia Altavilla discussed age-tailored assent forms for European Reference Networks on rare diseases.

The General Assembly, chaired by Annagrazia Altavilla, reviewed the network’s activities and collaborations, emphasizing children’s rights and their involvement in health research. Donato Bonifazi discussed TEDDY’s participation in projects like EJP-RD and EPTRI, and proposed expanding TEDDY’s legal status to a European dimension.

The assembly approved the short-term action plan and re-elected Annagrazia Altavilla as Chair for the next two years. Key members present included Annagrazia Altavilla, Adriana Ceci, Donato Bonifazi, Dr. Inmaculada Calvo Penadés, Maria Cavallo, and Begonya Nafria Escalera, with additional members online, confirming the legal quorum.

The TEDDY General Assembly (GA) meeting was held virtually on June 22, 2021, due to the COVID-19 pandemic. The Chair, Annagrazia Altavilla, opened the meeting with an update on TEDDY’s activities over the past year and plans for future initiatives. She highlighted a forthcoming workshop on “Modelling & Simulation (M&S)” for rare diseases, aimed at enhancing research methodologies for small populations. Additionally, TEDDY will contribute to a new Guide of the Council of Europe on children’s participation in health-related decision-making.

Fabio D’Atri from the European Commission discussed the review of regulations on medicines for children and rare diseases, emphasizing the need for revised paediatric regulations to enhance research and availability while maintaining core legislative frameworks. Laurence Lwoff from the Council of Europe presented survey results on strengthening children’s participation in healthcare decision-making, revealing the necessity for better education and multidisciplinary approaches.

The TEDDY-EPMD tool, an online database for paediatric medicines registered under the EMA, was introduced, showing significant progress in paediatric drug development but indicating areas for improvement. Oscar della Pasqua discussed innovative clinical trial methodologies, while Cosimo Damiano Altomare presented advances in in silico drug discovery for paediatrics.

Madlen Gazarian and Saskia de Wildt provided international perspectives on off-label medicine use in paediatrics, highlighting ethical considerations and regulatory differences. Jean Herveg addressed GDPR compliance in paediatric research, noting the importance of Codes of Conduct. Mariangela Lupo and Begonya Nafria outlined training activities for young patients under the EJP RD project.

The meeting also featured the TEDDY Kids serious game “My Clinical Trial Centre,” designed to educate children about clinical trials. Finally, Donato Bonifazi presented the financial statements, reporting a positive balance and plans for maintaining financial stability in 2021. The assembly approved the financial statements, budget, and membership fee.

The TEDDY General Assembly convened virtually on April 8, 2020, due to the COVID-19 pandemic. Donato Bonifazi opened the meeting, stressing the importance of reorganizing the TEDDY Network to adapt to the evolving pediatric research landscape. Following the last GA meeting, a temporary board was appointed to redefine TEDDY’s mission, activities, and legal structure. Annagrazia Altavilla reported on potential legal forms for TEDDY, including a European economic interest group, a European foundation, and a research association under Belgian law. However, due to ongoing efforts to establish a European foundation framework, it was decided for TEDDY to remain an Italian association for the time being.

Donato Bonifazi provided updates on TEDDY’s recent activities, highlighting its new membership in the Enpr-EMA Coordinating Group and involvement in five Enpr-EMA Working Groups. TEDDY also collaborated with ENCePP in revising post-authorization studies for the pediatric population and participated in several European research initiatives, including the ID-EPTRI and EJP RD projects. Additionally, TEDDY supported the RESTORE initiative, aiming to advance therapies for better patient outcomes.

TEDDY’s communication efforts included disseminating relevant information through newsletters, the website, and social media. The assembly also discussed TEDDY’s mission, emphasizing innovative research methodologies, ethical considerations, and stakeholder engagement in pediatric research. The financial statements were approved, showing positive balance. The assembly approved the new statute, renaming the network “TEDDY – European Network of Excellence for Paediatric Research” and outlining its organizational structure and activities. The new Board of Directors was appointed, with Annagrazia Altavilla as Chair, and plans were made for the first board meeting.

The General Assembly of TEDDY held in Madrid in 2019 focused on various critical aspects of paediatric clinical research. The meeting commenced with discussions on the achievements and future direction of the TEDDY Network, emphasizing the importance of continued collaboration and innovation in paediatric research.

 A significant highlight was the PedCRIN project, which aimed to improve the quality of paediatric clinical trials through enhanced coordination and certification of Clinical Trial Units (CTUs). The DEEP project was another key topic, stressing the need for child empowerment and active involvement in clinical trials. It was demonstrated that utilizing age-appropriate informative materials significantly enhances children’s understanding and engagement in research.

 Additionally, discussions addressed the development and dissemination of these materials, including the creation of booklets tailored to different age groups and the evaluation of their effectiveness. The assembly also covered advanced therapies in paediatrics, highlighting the regulatory landscape and the importance of ethical considerations in clinical trials.

Throughout the meeting, the emphasis was on fostering an environment that supports high-quality, ethical, and inclusive paediatric research, ensuring the active participation and empowerment of young patients in the process.

The TEDDY General Assembly meeting held on January 14, 2018, at the Hotel Ripa in Rome, focused on the future perspectives of TEDDY as an international network with legal personality.

The session was chaired by Maria Mellado and Oscar Della Pasqua, who welcomed participants and outlined the objectives, including sharing future plans, consolidating research groups, and promoting good practices in paediatric research. Adriana Ceci, President of Gianni Benzi Pharmacological Research Foundation, provided an overview of TEDDY’s evolution and achievements, highlighting milestones such as TEDDY’s foundation in 2005 and its status change within the European Network of Paediatric Research at the EMA.

The assembly discussed various topics, including the ethical and regulatory aspects of paediatric clinical trials, off-label drug use, and the development of a comprehensive European Paediatric Medicines Database. The meeting also involved the appointment of members to the TEDDY Scientific Coordination Committee and the Strategic Planning Board.

Key projects and initiatives, such as the PedCRIN project, aimed at enhancing international collaboration in paediatric research, and the conect4children Network, which seeks to optimize clinical trials delivery in children, were introduced.

The assembly underscored TEDDY’s role in fostering collaboration across scientific communities, companies, regulators, and networks to advance paediatric research.

The TEDDY General Assembly meeting held on January 14, 2018, at the Hotel Ripa in Rome, focused on the future perspectives of TEDDY as an international network with legal personality.

The session was chaired by Maria Mellado and Oscar Della Pasqua, who welcomed participants and outlined the objectives, including sharing future plans, consolidating research groups, and promoting good practices in paediatric research. Adriana Ceci, President of Gianni Benzi Pharmacological Research Foundation, provided an overview of TEDDY’s evolution and achievements, highlighting milestones such as TEDDY’s foundation in 2005 and its status change within the European Network of Paediatric Research at the EMA.

The assembly discussed various topics, including the ethical and regulatory aspects of paediatric clinical trials, off-label drug use, and the development of a comprehensive European Paediatric Medicines Database. The meeting also involved the appointment of members to the TEDDY Scientific Coordination Committee and the Strategic Planning Board.

Key projects and initiatives, such as the PedCRIN project, aimed at enhancing international collaboration in paediatric research, and the conect4children Network, which seeks to optimize clinical trials delivery in children, were introduced.

The assembly underscored TEDDY’s role in fostering collaboration across scientific communities, companies, regulators, and networks to advance paediatric research.