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Monthly Archives: November 2015
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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Cardiac Safety – the regulatory perspective
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
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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Introduction to EUFEMED & European Training Course in Human Pharmacology
Dr Jörg Täubel, EUFEMED Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link). Jörg explained that the AHPPI is a founder member of EUFEMED, which was born after a long gestation on 20 … Continue reading
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Use of a Novel Risk Rating System in Early Clinical Trials
Dr Brian Leaker, Respiratory Clinical Trials. Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link). Brian outlined the structure of his unit and, in particular, the research side of the operation. The … Continue reading
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We’ve setup a company page on Linkedin
To complement the private group that we have had running on Linkedin for some time, we have now opened up a public ‘company page’. You may follow us there!
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Risk Management for Early Trials in Biologicals
Dr Richard FitzGerald, Royal Liverpool University Hospital. Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link). Starting with TeGenero and referring to subsequent guidelines for Phase I trials from such bodies as … Continue reading
Risk Management in a CRO Phase I Unit
Dr John Lambert, PAREXEL. Proceedings from AHPPI’s conference on Risk Management in Early Phase Clinical Trials, 29 Oct 2015 (link). John introduced his talk by describing the changing face of early phase clinical trials and the potential for ‘risk’ in … Continue reading
AVAILABLE NOW: 2015 AHPPI Conference Presentations
Thursday 29-October-2015 Academy of Medical Sciences, London The presentations from this year’s AHPPI Annual Meeting have been uploaded to the conference page (link).
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