Category Archives: AHPPI News

AHPPI Attending the HRA Phase 1 Advisory Group Meeting, London, 09-Feb-2016

The National Health Service Health Research Authority (HRA) has a special interest group focusing on Phase 1 clinical trials. An excerpt from their web site: The Phase 1 Advisory Group is established by the HRA as a forum to discuss issues … Continue reading

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Statement on the Recent Serious Adverse Events During a Clinical Trial in Europe

The European Federation for Exploratory Medicines Development (EUFEMED) yesterday posted a statement about the widely reported death and serious illnesses occurring in an exploratory clinical trial in Europe (link PRNewswire). EUFEMED is headquartered in Brussels and constitutes the federated member associations of … Continue reading

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Survey Results for AHPPI’s Annual Meeting

Steffan Stringer, published 23-Dec-2015. Correspondence steffan.stringer@alwynconsulting.co.uk. ©2015 Steffan Stringer, Alwyn Consulting, www.alwynconsulting.co.uk This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original … 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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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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