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European Pharma Prepped for New Drug Development Rules Effective This Week

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The 2nd annual Avoca Quality Consortium (AQC) European Summit, which took place in Dublin, Ireland this year, prepared members for the new ICH E6 R2 guidelines which will be implemented across Europe on the 14th June 2017.

The Summit, which brought together industry leaders across Europe from the clinical trials space, hosted a wide range of speakers and discussion forums, to debate how the European clinical trial industry could advance with best practice in a changing landscape.

Ms. Patricia Leuchten, CEO and Founder of The Avoca Group, opened the conference with a welcome address highlighting the changing landscapes of clinical trials across Europe. This was supported by the Consortium’s new ‘Regulatory Roadmap’ which is a set of practical guidelines, tools, and documents, recently released by the group, to empower AQC members to understand and better prepare for the newly rolled out ICH E6 R2 guidelines.

“The AQC’s focus is on supporting our members and the work they do by providing them with leading practices and information that will help them drive efficiency and identify and mitigate risks in clinical trial execution. For example, Avoca began our work on the components of ICH E6 R2 five years ago, and as a result, we are now well placed to support the industry when the new regulatory guidelines are released in Europe next week," said Ms. Leuchten.

Professor Dipak Kalra, President of the European Institute for Innovation through Health Data, who addressed the Summit as one of the key note speakers, spoke of the current challenges facing the clinical trial space in Europe.

“There is a real need from society and healthcare systems for greater clinical trials efficiency to deliver new medicines faster to patients. Pharma and CROs need to make better, more trustworthy use of hospital electronic clinical records systems across Europe to optimise clinical trial protocols and facilitate patient recruitment.”

While much discussion at the Summit was focused on operational issues, panellists and attendees also raised critical questions about how to continue to build a culture of quality within individual organizations. "The landscape of clinical trials is evolving, and the pace of change is rapid," says Leuchten. "The Summit is an opportunity for us to make decisions about how to address the complexities we face as an industry. Through our collaboration model, our goal is to elevate quality while introducing greater efficiency into the clinical trials process for the collective benefit of the industry."

December 2016 was the fifth anniversary of the Quality Consortium and 2017 is the second year that, due to member interest, the AQC held a Summit in Europe. Ideas discussed at the Summit are put into practice through the work of the Consortium. 

This article has been republished from materials provided by AVOCA Quality Consortium. Note: material may have been edited for length and content. For further information, please contact the cited source.