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Meta
Tag Archives: CTR
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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Update on the implementation of the new EU Clinical Trial Regulation’s transparency rules for early phase trials
Dr Ulrike Lorch, AHPPI Chair-elect Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link). The new EU Clinical Trials Regulation (EU CTR) is intended to stimulate innovation, research and development in Europe. … 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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REFORMATTED 2014 AHPPI ANNUAL MEETING!
COMPLETELY NEW FORMAT FOR 2014 AHPPI ANNUAL MEETING! Academy of Medical Sciences, London, Thursday 30th October 2014. We are pleased to announce that AHPPI members are invited to speak at this year’s conference. In contrast to previous years, the meeting will … Continue reading
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