-
Archives
- June 2018
- February 2018
- May 2017
- January 2017
- December 2016
- November 2016
- October 2016
- May 2016
- April 2016
- March 2016
- February 2016
- January 2016
- December 2015
- November 2015
- October 2015
- August 2015
- July 2015
- June 2015
- March 2015
- February 2015
- September 2014
- July 2014
- January 2014
- November 2013
- July 2013
- June 2013
- April 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- June 2012
- May 2012
- March 2012
- December 2011
- November 2011
- July 2011
- March 2011
-
Meta
Category Archives: AHPPI News
New Committee Members
At our last managing committee meeting, the AHPPI welcomed the following new committee members. We are very fortunate to have them on the team and look forward to working with them. Dr Muna Albayaty Medical Director, PAREXEL, London Muna is a Consultant … Continue reading
Comments Off on New Committee Members
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
Comments Off on EMA stakeholder activity – User Acceptance Testing of new EU portal
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
Comments Off on Evening with the Experts
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
Comments Off on AHPPI Now Accepting GoCardless Direct Debit payments
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
Comments Off on AHPPI Attending the HRA Phase 1 Advisory Group Meeting, London, 09-Feb-2016
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
Comments Off on Statement on the Recent Serious Adverse Events During a Clinical Trial in Europe
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
Comments Off on Survey Results for AHPPI’s Annual Meeting
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
Comments Off on Sponsors have up to 30 months after the end of a trial to publish results of Category 1 trials under EU CTR
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
Comments Off on Update on the implementation of the new EU Clinical Trial Regulation’s transparency rules for early phase trials
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
Comments Off on Cardiac Safety – the regulatory perspective