Facilitation of Paediatric Research in Japan

2010 ◽  
pp. 15-22 ◽  
Author(s):  
Hidefumi Nakamura ◽  
Masahiro Ozaki
Keyword(s):  
Paediatric Research

Ethical, Legal and Regulatory Issues of Paediatric Translational Research. Call for an Adequate Model of Governance

2020 ◽  
Vol 27 (3) ◽  
pp. 213-231
Author(s):  
Annagrazia Altavilla ◽  
Viviana Giannuzzi ◽  
Mariangela Lupo ◽  
Donato Bonifazi ◽  
Adriana Ceci
Keyword(s):  
Translational Research ◽  
Research Infrastructure ◽  
Paediatric Research ◽  
Adequate Model ◽  
Regulatory Issues ◽  
Societal Issues ◽  
Translational Approach ◽  
Legal Frameworks ◽  
Ethical Oversight ◽  
Paediatric Medicines

Abstract The lack of paediatric medicines, including innovative and advanced ones, is a long-lasting and well-known problem at European and international levels. Despite the existing legal frameworks and incentives, children remain deprived of many kinds of therapy because of challenges faced in appropriately study and tailoring medicinal and other products for them. In this context, the necessity to foster paediatric research addressing unsolved and uncovered issues within a ‘translational approach’ has appeared. This article, after having clarified the concept of translational research in the perspective of the establishment of a European paediatric research infrastructure (RI), will identify and point out ethical, legal and regulatory issues particularly relevant in a children’s rights perspective. It concludes asking for the setting up of an adequate model of governance within a future RI, including adequate and independent ethical oversight and a pluridisciplinary common service dealing with ethical, legal and societal issues relevant for children.

Paediatric Research under the New eu Regulation on Clinical Trials: Old Issues New Challenges

2016 ◽  
Vol 23 (4) ◽  
pp. 325-349 ◽  
Author(s):  
Éloïse Gennet ◽  
Annagrazia Altavilla
Keyword(s):  
Clinical Trials ◽  
Implementation Process ◽  
Paediatric Research ◽  
Ethical Guidelines ◽  
Eu Regulation ◽  
Paediatric Regulation ◽  
New Challenges

Regulating paediatric research means searching for the balance between two valuable goals: protecting children while ensuring they benefit from safe and efficient medicines. Different legal instruments were adopted in the eu in order to regulate clinical trials, foster paediatric research and promote European and international ethical guidelines. However a new Regulation on clinical trials was adopted in 2014, and might change the current framework of paediatric research. How does the new Regulation 536/2014 foster research on children taking into account both the eu Paediatric Regulation and the eu Ethical Recommendations? Does it live up to the standards of the Directive 2001/20/ec and does it represent a step forward in accordance with international ethical guidelines? This article shows that, despite the adoption of new rules, many clarifications are still needed. Stakeholders involved in paediatric research have to play a driving role in the implementation process of the new Regulation.

scholarly journals Palliative medicines for children - a new frontier in paediatric research

2016 ◽  
Vol 69 (4) ◽  
pp. 377-383 ◽  
Author(s):  
Liz Jamieson ◽  
Ian C. K. Wong ◽  
Finella Craig ◽  
Nanna Christiansen ◽  
Karen Brombley ◽  
...  
Keyword(s):  
Paediatric Research ◽  
New Frontier ◽  
Medicines For Children
Sign in / Sign up

Export Citation Format

Share Document