The article “Informed consent and assent guide for paediatric clinical trials in Europe” has been recently published
A guide for informed consent and assent for children
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News
Spina Bifida: Trans-ERN workshop on research and treatment
A new EJP RD workshop titled “Trans-ERN Working Group for Spina Bifida (Spinal Dysraphism): Workshop for future research on innovative diagnostics and interdisciplinary treatment” is being organised
Paediatric medical device development: challenges&oppportunities
The article Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities has just been published on Pharmaceutics.
Domain specific Common Data Elements (DCDEs) Curation
EJP RD is co-organising a meeting on Domain specific Common Data Elements (DCDEs) Curation to be held on December 9th, 2021 from 16.00 – 17.00 CET.
EMA reflection paper on statistical methods for drug quality assessment
A Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development has been released by EMA
EMA updates explanatory note on fees and charges
EMA released the updated version of the Explanatory note on general fees payable to the European Medicines Agency in July 2021
European Commission’s GLSP guidance for clinical trials
In October 2021, the European Commission (EC) released the Good Lay Summary Practice (GLSP) Guidance
WHO recommends governance for human genome editing
The Committee produced a series of recommendations on appropriate institutional, national, regional and global governance mechanisms for human genome editing
Consultation on GDPR guidelines for international data transfers
The European and international transfer of data is one of the main topics since the coming into force of the General Data Protection Regulation.
EDPB’s 2021 guidelines on GDPR roles
On July 2021, the European Data Protection Board released the second version of the Guidelines 07/2020 on the concepts of controller and processor in the GDPR
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