News

The Italian Medicines Agency AIFA withdraws the paediatric indication for domperidone-containing products

The Italian Medicines Agency AIFA has just released a safety communication about the use of medicines containing domperidone. Domperidone-containing medicines have been authorised nationally in individual Member States of the EU for the treatment of nausea and vomiting of various causes since 1970s, with the first approval in Belgium in March 1978. The AIFA communication

June 5th, 2019|

TEDDY is involved in the RESTORE project

We are happy to announce that the TEDDY Network is involved as supporter in RESTORE, a large-scale Research Initiative with the scope to create a consortium aimed to build a coordinated, financially strong, academia-industry partnership in order to tackle the main interdisciplinary science and technology challenges for advanced and innovative health therapies. The consortium is

May 9th, 2019|

EMA Consultation: ICH guideline E19 on optimisation of safety data collection

EMA has launched a public consultation on the draft ICH Guideline E19 relating to optimization of safety data collection in late-stage pre-approval or post approval studies and promoting selective safety data collection to limit useless burden to study participants (when the safety profile of a drug is sufficiently characterized). This guideline explores under what circumstances

May 9th, 2019|

HMA/EMA TASK FORCE ON BIG DATA

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

May 9th, 2019|

FDA Finalises Guidance on Paediatric Information in Drug Labels

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

May 9th, 2019|

EMA Consultation: Electronic product information for human medicines in the European Union – draft key principles

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)

May 9th, 2019|

KIDS Bari participated in the OPBG Innovation Meeting on 28 March, 2019

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

May 9th, 2019|

Drug Discovery and Development – “Challenges and New Frontiers in the Paediatric Drug Discovery and Development” – the chapter is online!

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

May 9th, 2019|

GA TEDDY 2019: a follow up on the Network activities

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

May 9th, 2019|

TEDDY – European Paediatric Medicines Database – EPMD

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

May 9th, 2019|