Rome, January 14th, 2018.

The TEDDY General Assembly (GA) entitled “A new phase for paediatric clinical research: a play role for TEDDY?” was held in Rome to provide an update on the achievements reached by the Network over the last years.

Since 2005, when the Network arose from the Task-force in Europe for Drug Development for the Young and was funded within the Sixth Framework Programme of the European Commission, it has reached several goals, becoming category 4 Member of Enpr-EMA (European Network of Paediatric Research at the European Medicines Agency) in 2014 and category 1 in 2016. In 2018, TEDDY has assumed a legal status to be fully represented in the European paediatric research framework.

The TEDDY GA was the occasion to discuss about the future perspectives of the TEDDY Network as International subject in the European scenario. After an overview on the evolution of the TEDDY Network and the main milestones reached by the Network over the last years, it was presented the new TEDDY statute that allows the adhesion of natural and legal persons within two categories of members: Ordinaries (they are physical persons participating to the network activities) and Supporters (they are legal entities contributing to the network activities).

During the morning session, TEDDY operative groups and their plans of action were presented:

• Standard Operating Procedures for the conduct of paediatric clinical trials;
• Ethic Issues and interactions with Ethic Committees;
• Off-label medicines use in paediatrics;
• Regulatory procedures for paediatric clinical trials;
• Inventory of clinical sites and facilities for clinical trial feasibility;
• Pharmacovigilance;
• Active engagement of children and adolescents in the themes of clinical research;
• Advanced therapies in paediatrics.

The afternoon section began with the discussion about the TEDDY Network Bodies.  All the participants agreed on the proposed composition of the Scientific Coordination Committee (Annagrazia Altavilla, Adriana Ceci, Giovanni Migliaccio, Oscar della Pasqua, Francesca Rocchi, Saskia de Wildt) and of the Strategic Planning Board (Carlo Giaquinto, Maria Mellado, Marek Migdal, Miriam Sturkenboom, Mark Turner, Ian Wong). After that, there were various interventions mainly focused on:

• projects and initiatives in which TEDDY is involved, such as PedCRIN (Paediatric Clinical Research Infrastructure Network), Connect4children Network (C4C) and the new paediatric research infrastructure EPTRI (European Paediatric Translational Research Infrastructure);
• the European landscape in terms of scientific research communities, companies, regulators and Networks in which TEDDY network will operate;
• the contribution of TEDDY in paediatric trials and research.

The meeting was attended by about 80 participants from several research organizations, academic institutions, Research Infrastructures, paediatric hospitals, regulatory agencies and patients associations providing a fruitful debate on the advancement of the TEDDY actions to build a strong working basis for the forthcoming activities.

You can download the minutes of the meeting as well as all the presentations at this link.

Here you can also watch a video of the meeting.

Join the network to give your contribution by filling in the association form here and send back to: [email protected].