The scope of this Reflection Paper is to clarify the practical application of requirements for clinical trials conducted outside of the EU/EEA and submitted in Marketing Authorisation Applications to the EMA (through the centralised procedure) or to National competent Authorities (through decentralised, mutual recognition, or national procedures) . The Paper set up practical steps to be undertaken during the provision of guidance and advice in the medicine development phase and during the evaluation of Marketing Authorisation Applications.
View this resource Bookmark this resourceEMA
Guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic
Published by EMA
Clinical TrialsPandemyThe guidance provides concrete information on changes and protocol deviations which may be needed in the conduct of clinical trials to deal with extraordinary situations, e.g. if trial participants need to be in self-isolation or quarantine, access to public places (including hospitals) is limited due to the risk of spreading infections, and healthcare professionals are being reallocated
View this resource Bookmark this resource
Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
Published by EMA
Clinical TrialsPandemyThis document points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
View this resource Bookmark this resourceThis document was developed by a working group of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) 1 and sets out recommendations for discussions about clinical trial preparedness in paediatrics.
View this resource Bookmark this resource
Clinical Trials Facilitation and Coordination Group Guidance document for sponsors for a Voluntary Har
Published by EMA
Clinical TrialsThe main objectives of the assessment of the CT are to ensure the quality of the IMP and the safety of the trial subjects.
View this resource Bookmark this resource
ICH E9 (R1) Addendum on Estimands and Sensitivity
Analysis in Clinical Trials to the Guideline on Statistical
Principles for Clinical Trials
Step 5
Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)EMA
Statistical PrinciplesClinical TrialsThis document is an addendum on estimands and sensitivity
analysis in clinical trials to the guideline on statistical
principles for clinical trials
