Category Archives: AHPPI News

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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Evening with the Experts

This year we shall be offering a new benefit for members. We are looking to host two hour meetings held in the evening (e.g. 18:00 to 20:00) up to four times a year. The venues would probably be a Phase I unit, … Continue reading

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AHPPI Now Accepting GoCardless Direct Debit payments

AHPPI has launched a new way for you to pay your annual membership subscription, using GoCardless, a simple, secure service to set-up Direct Debit payments on line, authorised by the Financial Conduct Authority. This method will be applicable to holders of … Continue reading

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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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