The new EMA action plan to support SMEs as drivers of pharmaceutical innovation

On 31th May, 2017 the European Medicines Agency (EMA) published an action plan for small and medium-sized enterprises (SMEs), which aims to foster innovation and support SMEs in the development of novel human and veterinary medicines. This action plan builds on existing measures introduced to support SMEs pursuant to Commission Regulation (EC) No 2049/2005 and addresses the

October 4th, 2017|

Revised guideline on first-in-human clinical trials

On 25th, July 2017, the European Medicines Agency (EMA) published a revision of the guidance on first-in-human clinical trials, that will come into effect on February 1st, 2018. The guidance addresses non-clinical issues for consideration prior to the first administration of an investigational medicinal product in humans. It also focuses on the design and conduct

October 4th, 2017|

Publication: “Tuberculosis treatment for children: An update”

In July 2017, the Article “Tuberculosis treatment for children: An update” has been published on-line in “Anales de Pediatría” Journal. The publication reports the updated international guidelines for the management of paediatric Tuberculosis (TB) in Spain, reviewed by a group of paediatric TB experts, among which some researchers of the TEDDY Network, such as Maria

October 3rd, 2017|

KIDS Albania – the first YPAG in Albania!

Consorzio per Valutazioni Biologiche e Farmacologiche – Dege e shoqerise se huaj, Albanian Branch Office in collaboration with the TEDDY Network (European Network of Excellence for Paediatric Clinical Research) and University Hospital Center Tirana “Mother Teresa”, Service of Paediatrics), promoted the first YPAG (Young People Advisory Group) in Albania, named KIDS Albania. KIDS Albania

September 25th, 2017|

A recent publication appeared in BMJ Paediatrics Open 2017 provides a comprehensive overview about the roles and training of paediatric research nurses working across Europe

The article “Investigating the roles and training of paediatric research nurses working across Europe: a questionnaire-based survey”, aimed to identify potential training needs and compare the roles of research nurses across specialties and countries, has been published in BMJ Paediatrics Open 2017. Research nurses represent key figures among the clinical trial personnel to conduct a

September 25th, 2017|

X Foresight Training Course, October 27th-28th, 2017

Also this year the Gianni Benzi Pharmacological Research Foundation organises the annual Foresight Training Course (FTC), at its tenth edition now. The meeting, entitled ‘THE EUROPEAN MEDICINES REGULATORY NETWORK: PRESENT AND FUTURE’, will focus on: – the main innovations in the European Pharmaceutical System; – putting patients in the core of the system; – the

September 22nd, 2017|

ID-EPTRI approval: a great success for paediatric medicines development

We are very pleased to announce that the ID-EPTRI (European Paediatric Translational Research Infrastructure) project, coordinated by CVBF and submitted within the INFRADEV-2016-2017 single-stage call for proposals, aimed to create the framework for a new paediatric Research Infrastructure (RI)  has been successfully evaluated and granted 3.00 million Euro in funding from the European Commission.

September 1st, 2017|

TEDDY promotes its collaborative groups aimed at favouring paediatric clinical research

The TEDDY network is working to launch a series of collaborative operating groups, focused on the most relevant topics of paediatric clinical research. This action is intended to convey the Network expertise and experience to deliver useful instruments for the promotion and the concrete support of paediatric clinical research. It arises from the collaborative nature

August 11th, 2017|