December 24th, 2015
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 Welcome to the first edition of TEDDY newsletter!

From now on, you will be receiving regular updates of the TEDDY Newsletter, with all the Network ongoing activities and initiatives, including papers, reports on activities involving paediatric research. We invite all of you to share with us any suggestions or proposals that we can publish on the website in order to make this a useful instrument for our Network-related activities to be disseminated through the paediatric communities!

We wish all of you a Merry Christmas and a Happy New 2016!

TEDDY contribution in the development of "transition from paediatrics to adults" theme

During the last EnprEMA workshop, held in May 2015, adhering networks have been invited to provide a feedback on published guidance documents on the topic of transition from paediatrics to adults clinical care settings within the long-term clinical studies and follow up for chronic diseases.

To this aim, TEDDY partners collected and shared with EnprEMA Coordination Groups several recent publications on the theme, deriving from their direct research experience or knowledge.

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TEDDY is now a registered network at ENCePP

We are happy to announce that TEDDY is a registered network at the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP, since September 2015. ENCePP is an initiative coordinated by the European Medicines Agency (EMA) with the aim of strengthening post-authorisation research, pharmacoepidemiological research and risk-benefit monitoring of medicines.
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TEDDY Network's activies updates- June 2015

During the Enpr-EMA seventh annual workshop, held at the EMA in London, on Thursday 28th May, 2015, it was  agreed to ask all Enpr-EMA registered networks to provide a short written paragraph with regards to any news or  achievements which each network considers as being important and which has happened since the last Enpr-EMA workshop in June 2014.

The summary of the most relevant TEDDY initiatives conducted in the last year has been prepared and sent to Enpr-EMA as well as posted on the TEDDY website.

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The article "Clinical Trial Application in Europe: What will change with the New Regulation?" is now available at the Science and Engineering Ethics journal

On June, 3rd 2015 the article entitled “Clinical Trial Application in Europe: What Will Change with the New Regulation?” has been published on theScience and Engineering Ethics journal.

The authors (Viviana Giannuzzi, Annagrazia Altavilla, Lucia Ruggieri and Adriana Ceci), address the challenges derived from the Clinical Trial Regulation recently issued by the European Commission that is changing the European legal framework surrounding clinical trials on medicinal products for human use. In this work, the European rules governing the Clinical Trial Application have been analysed, also dealing with special issues, such as paediatric research and trials involving non European countries.

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"Clinical Trials in Paediatrics - Regulatory and Methodological Aspects" chapter is now online!

“Clinical Trials in Paediatrics - Regulatory and Methodological Aspects” chapter is now online! On June, 2015,  the chapter entitled “Clinical Trials in Paediatrics - Regulatory and Methodological Aspects” and included in the book Drug Discovery and Development – From Molecules to Medicine, ISBN 978-953-51-2128-2, edited by Omboon Vallisuta and Suleiman Olimat has been released online.

This chapter has been written with the contribution of Adriana Ceci, Viviana Giannuzzi, Donato Bonifazi, Mariagrazia Felisi Fedele Bonifazi and Lucia Ruggieri on behalf of TEDDY-CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche).

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AICRO - Milan, November 12th, 2015
On November 12th, 2015 the Italian Association Contract Reseach Organisation (AICRO) organised in Milan (Hotel Principe di Savoia) the event entitled Le “sfumature” della ricerca clinica in Italia, an entirely day dedicated to the clinical research that will address issues on the evolving of new ways of managing clinical trials in Europe (and specifically in Italy), including the synergies between AICRO and clinical trial centres.

The Meeting has been organised under the patronage of TEDDY that recognizes and shares the theme of the clinical research among its institutional aims and supported the initiative.

VII Foresight Training Course - Warsaw, September 22nd-23rd, 2015
On September 22nd-23rd, 2015, the Children’s Memorial Health Institute in Warsaw (Poland) hosted the VIII edition of the Foresight Training Course (FTC) entitled "Regulatory And Practice In Paediatric Trials And Studies" promoted by Gianni Benzi Foundation (Italy) and GRiP (Global Research in Paediatrics) – Work Package 4, led by CVBF-TEDDY.
The event was a good opportunity to discuss, in the framework of an international multi-stakeholders debate, the present and the future of the paediatric research including the efforts made by the scientific community and the ongoing projects such as the proposed Paediatric Research Infrastructures (EPCTRI) and the global networks.
TEDDY Network is coordinated by:

Consorzio per Valutazioni Biologiche e Farmacologiche

I-27100 PAVIA Via Luigi Porta 14 – Tel. +39 0382 25075
I-70125 BARI Corso Alcide De Gasperi 435 – Tel. +39 080 8641260

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