Tag Archives: cardiac safety

Cardiac Safety – the regulatory perspective

Posted On 17-Nov-2015 by Steffan Stringer

Dr Krishna Prasad, MHRA Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link).     Krishna reviewed the status quo pointing out that the regulations were a success in that no drugs having undergone E14 … Continue reading →

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Cardiac Safety – the industry perspective

Posted On 16-Nov-2015 by Steffan Stringer

Dr Boaz Mendzelevski, BioClinica Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link).     This year marks the 10th anniversary of the introduction of the ICH E14 guideline which was introduced to provide … Continue reading →

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Faculty conversation: TQT study – this is the end!

Posted On 21-Jul-2015 by Sam Welgemoed

Recently, the FDA, other regulatory bodies, and pharmaceutical companies have been exploring options to replace TQTs with preclinical testing or with data collected during standard Phase I trials. Join colleagues from the FPM and also the British Pharmacological Society and … Continue reading →

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Message from Chair: Presentations from the Joint Conference of European Human Pharmacological Societies

Posted On 26-Feb-2013 by Kristy

Dear Members, I have recently returned from a very successful and interesting International meeting in France held between the French (Club Phase 1), German (AGAH), Belgian (BAPU) and UK (AHPPI),human pharmacological societies.  The meeting was entitled EARLY CLINICAL UTILITY ASSESSMENT … Continue reading →

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