8th Jul 2016, 12:51 PM
EU Clinical Trials New Regulation – Important Consultations HAVE YOUR SAY
EU Clinical Trials New Regulation – Major developments on Risk Proportionate Guidance; Trial Results for Laypersons; Definitions of IMP and AMPs; Ethical Considerations for Minors.
HAVE YOUR SAY
The following guidance which has been developed in preparation for the implementation of the Clinical Trial Regulation (EU) No 536/2014 is currently out for public consultation from 1 June 2016 to 31 August 2016 by the European Commission:
Risk Proportionate Approaches in Clinical Trials
The main objective of this document is to provide further information on how a risk proportionate approach can be implemented in clinical trials and highlights areas within the clinical trials Regulation which support such adaptations.
Please submit your contributions by e-mail to:SANTE-B4-GLfirstname.lastname@example.org
Summary of Clinical Trial Results for Laypersons
Article 37 of the Clinical trial Regulation (EU) No 536/2014 requires that sponsors provide a summary of clinical trial results in the EU Portal and Database, in a format understandable to laypersons. The main objective of this document is to provide recommendations and templates for the production of a summary of clinical trial results for laypersons by sponsors and investigators, in accordance with Annex V of the EU Clinical Trials Regulation.
Please submit your contributions by e-mail to: SANTE-B4-GLemail@example.com
Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)" (previously called "Guidance on Investigational Medicinal Products (IMPS) and Non-Investigational Medicinal Products (NIMPs))
The main objective of this revision is to align it with the Clinical Trials Regulation and with the latest (scientific) insights.
Please submit your contributions by e-mail to: SANTE-B4-GL-IMP-AMP@ec.europa.eu
Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors
The main objective of this revision is to align the document with the Clinical Trials Regulation (EU) No 536/2014 and with the latest (scientific) insights on research with children.
Please submit your contributions by e-mail to: SANTE-B4-GL-Ethics-Minors@ec.europa.eu
The link below will direct you to the European Commission website:
Do not send your contributions to the MHRA, please send to the address provided by the Commission.
Last edited by MHRA Super Moderator; 8th Jul 2016 at 12:55 PM.
Reason: correct header