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Dec 2, 2015

MHRA wants to see paper records retained
MHRA commented in their discussion forum on retention of trial records

MHRA modifies its position on destruction of paper from that offered by the MHRA GCP Guide (2012): “The use of an eTMF would be considered as a prerequisite to the sponsor’s being able to destroy paper records and reduce storage requirements. ...transfer of the document to an eTMF repository could enable earlier destruction of the paper original. ...early, complete destruction of such records is not currently recommended or should only be undertaken on a risk-adapted approach. The current recommendation is to undertake a risk assessment in order to decide which documents do not need to be retained on paper, particularly focusing on whether the paper version could be obtained or not upon request (e.g. reprinted or from another location).”

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ICH announces organizational changes!
The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural meetings of its new Assembly and Management Committee on 23 October 2015

The reforms will mean that ICH is a truly global initiative, expanding beyond the current ICH members. More involvement from regulators around the world is welcomed and expected, as they will be invited to join counterparts from Europe, Japan, USA, Canada and Switzerland as ICH regulatory members. This is matched by the possibility of wider inclusion of global industry sectors affected by ICH harmonisation. The reforms strengthen ICH as the leading platform for global pharmaceutical regulatory harmonisation, and one that brings together in a transparent manner all key regulatory authorities and industry stakeholders.

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Widler & Schiemann to represent ACRES at EMA Inspectors Working Group
Peter Schiemann represented ACRES, the Alliance for Clinical Research Excellence and Safety at the EMA IWG Meeting on EDC systems and risk based monitoring in Clinical Trials

The EMA has called for an Inspectors Working Group on EDC systems and risk based monitoring in clinical trials on November 30, 2015 at their headquarters in London, UK. As one of global stakeholders, ACRES has been asked to send a representative to the meeting to partake in the discussions. The day is dedicated to discussing electronic systems supporting clinical trials, their advantages and associated risks. The second half of the day is dedicated to risk based monitoring approaches presented from industry and service provider perspective.

ACRES and Ethical GmbH, Switzerland to collaborate on eAdjudication
ACRES integrates eAdjudication into shared global platform of integrated technologies

The collaboration will initially explore opportunities for streamlining and improving the Endpoint Adjudication process effectiveness. Ethical GmbH's Endpoint Adjudication solutions bring the Ethical eAdjudication® Platform to ACRES shared global platform of integrated technologies to improve the integrity of data and reduce trial costs. Ethical GmbH and ACRES will also explore development of shared standards across service providers, stakeholders managing Endpoint Adjudication Committees and sponsors. Ethical GmbH will participate in ACRES' Foundation Initiatives related to quality management, contributing to the “dynamic accreditation” process being developed by the Alliance.

Beat Widler to present at the 2nd Academic Symposium
Beat Widler is invited to speak on the Clinical Research Quality & China New Drug 50 Roundtable Forum in Beijing, China

Beat Widler will speak at the conference about "Development and Management New Trends of Global Clinical Research" on December 4th 2015 in Beijing, China.


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