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Meta
Tag Archives: EMA
Revising the guideline on first-in-human clinical trials
The EMA yesterday published a guideline: Draft guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products The document can be found here. The consultation period ends 28-Feb-2017.
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EMA stakeholder activity – User Acceptance Testing of new EU portal
Q1 2016 saw the User Acceptance Testing of the new EU portal/Clinical Trial Application system begin. BioKinetic Europe, Niche Science & Technology and Richmond Pharmacology, all of whom have a network of active members in AHPPI are registered testers on behalf … Continue reading
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Sponsors have up to 30 months after the end of a trial to publish results of Category 1 trials under EU CTR
On 05 October 2015, the EMA signed the Appendix, on disclosure rules, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014”. In this document, the EMA introduces a new categorisation of clinical trials. Trials … Continue reading
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EUFEMED & EUCROF submission on publication of Category 1 clinical trial results
Following the recent stakeholder meeting on the transparency addendum for the EU portal and EU database, which took place at the EMA on 01 June 2015, the Exploratory Medicines Development (EUFEMED) and the European CRO Federation (EUCROF) have made a … Continue reading
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EUFEMED consultation response to EMA Draft proposal for an addendum, on transparency, to the ‘functional specifications for the European Union (EU) portal and EU database to be audited’
The EMA recently launched a public consultation on their “Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014”, for proposals and options on the application of … Continue reading
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