The 11th edition of the “Positive Psychology and interconnection: real and virtual communities” Days will take place on 15th and 16th June, 2018 at the University of Bari, and it will be focused on the perspectives and the potentialities of the virtual community as...
Misunderstanding about orphan medicines: a new document has been prepared by EMA in support of Rare Disease Day
The European Medicines Agency (EMA) has recently published a question-and-answer document to dispel any doubt on the meaning of orphan designation and other aspects related to orphan medicines Regulation in EU. The EU legislation foresees giving orphan designation for...
The launch of the EPTRI Survey
The project ID-EPTRI (European Paediatric Translational Research Infrastructure), coordinated by Consorzio per Valutazioni Biologiche e Farmacologiche with the aim to design the framework of a new Paediatric Research Infrastructure and involving TEDDY Network as third...
TEDDY is participating to EnprEMA Working Group for preparedness in paediatric clinical trials
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), through its Working Group for preparedness in paediatric clinical trials, is performing different actions aimed to facilitate the conduct of paediatric clinical studies focusing...
Participation in the Enpr-EMA pilot of the model for industry/network communication
The Working Groups 3 (Establish collaboration between Enpr-EMA networks and industry) and 5 (Sharing good practices within Enpr-EMA and with industry) of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has launched an initiative...
The 10th Conference of the European Paediatric Formulation Initiative (EUPFI) “Formulating better medicines for children” will be held in September 2018
The European Paediatric Formulation Initiative (EUFPI) in partnership with International for Pharmaceutical Technology will organize its 10th Conference entitled “Formulating better medicines for children” on 11-13 September 2018 at the University College London...
EUFEPS Annual Meeting 2018 in Athens, May 24-26
The European Federation for Pharmaceutical Sciences (EUFEPS) held its annual meeting on 24-26 May 2018 in Athens in collaboration with Conference Co-chair Prof. Panos Macheras supported by University of Athens and with parallel tracks organized by EUFPES Networks. The...
FDA Recommends Early, Pre-Approval Trials in Pediatrics for Systemic Dermatitis Drugs
A new effort to speed up paediatric drug development and arise awareness on the importance of clinical and pre-clinical paediatric trials has been done by the Food and Drugs Administration (FDA) that published a new draft guidance recommending early, pre-approval...
The new Guidelines on Consent under Regulation 2016/679: a new focus on the paediatric area
The Working Party on the protection of individuals with regard to the processing of personal data is an independent European advisory group on data protection and privacy that was set up under Article 29 of Directive 95/46/EC. On 10 April 2018, the Working Party...
Evaluation of EMA fee system for the approval and monitoring of medicines: public consultation has been launched
The European Commission has launched a public consultation as a part of a study supporting the evaluation of the fee system for the European Medicines Agency’s (EMA) activities relating to the approval and monitoring of medicines for people and animals. The study,...