Heads of Medicines Agencies (HMA) – EMA Joint Big Data task force published on 13 February 2019 a summary report on the main outputs and achievements of the task force. In preparing the report, it assessed the generation of “Big data”, their relevant resources and main formats, the methods for processing and analysing big data
The US Food and Drug Administration (FDA) in March released a guidance on the content and placement of paediatric information within the labelling of drugs and biologics products. The guideline provides recommendations to ensure that information on the use of prescription drugs in paediatric populations (whether positive, negative, or inconclusive) is consistently placed in the
The European Medicines Agency (EMA) has launched a six-month public consultation on draft key principles for Electronic Product Information (ePI) for human medicines in the EU. A medicine’s product information is regulated, scientifically validated information that assists healthcare professionals in prescribing and dispensing and informs patients and consumers about safe use. The product information (PI)
On March 28, 2019 the usual appointment with the Innovation Meeting promoted by the Paediatric Hospital Bambino Gesù was held in Rome. For more than one year, the Paediatric Hospital Bambino Gesù has been dedicating space and attention to these meetings, aimed to disseminate and share the latest news about research innovation in particular in
A chapter dedicated to the future perspectives of the paediatric drug discovery and development and written by Angelica Intini, Donato Bonifazi and Giovanni Migliaccio, has just been published on-line and will be included in the book entitled “Drug Discovery and Development - New Advances”, published by IntechOpen, one of the world’s leading publisher of open
On 29th March 2019 the TEDDY Network General Assembly 2019 took place at Ministry of Health, Consumption and Social Welfare in Madrid. The meeting was the occasion to renew the interest and commitment of TEDDY partners and participants in TEDDY activities and to reopen useful discussion on mission, vision and governance model of this first
The European Paediatric Medicines Database (EPMD) has been set up by TEDDY Network, with the aim of creating a harmonised, integrated and reliable pan-European source of information. The data stored in this database is the basis for examining the ‘state of the art’ of paediatric innovative medicines licensed by the European Medicines Agency (EMA) from
A chapter dedicated to the future perspectives of the paediatric drug discovery and development and written by the experts from Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) and TEDDY – European Netwrok of Excellence for Paediatric Clinical Research, Angelica Intini, Donato Bonifazi and Giovanni Migliaccio, has just been published on-line and will be included in
On 28 March, 2019 the usual appointment with the Innovation Meeting promoted by the Paediatric Hospital Bambino Gesù was held in Rome. For more than one year, the Paediatric Hospital Bambino Gesù has been dedicating space and attention to these meetings, aimed to disseminate and share the latest news about research innovation in particular in
blished on 13 February 2019 a summary report on the main outputs and achievement of the task force. In preparing the report, it assessed the generation of “Big data”, their relevant resources and main formats, the methods for processing and analysing big data and the current state of expertise across the European medicines regulatory framework.