ICH GCP E6 revision 2 is due to be finalized this summer and implemented later this year.
The impact on any company running clinical trials is going to be significant.
Companies need to start planning now to ensure adequate time for change management and implementation to occur.
This free webinar, focusing on quality management, will allow companies to quickly gain an understanding of the changes required by the guideline and what they are going to mean for them in real terms regarding their quality management practices, systems, and staff.
This webinar is free to all employees of companies actively engaged in the running of clinical trials.
The webinar will cover the following:
– What is the timeline for changes, and when do we expect adoption with EU and US regulatory agencies?
– What are the key components of the changes and what do they mean in terms of processes, roles and technology?
– What is the relationship between the changes and risk-based monitoring?
– What will it take to be compliant with the changes?
– What will it take to implement the changes?
– What solutions can be adopted to enable compliance?
– What your adoption road map should look like
Duncan Hall, CEO and founder, Triumph Research Intelligence
Duncan has over fifteen years of consultancy experience, thirteen of which have been within clinical R&D in both CRO and Pharma businesses. Duncan started Triumph in 2002 with the aim of building a global business which would be focused on improving the delivery, quality and value of clinical systems. Duncan now takes a primarily strategic role in TRI, but still performs client delivery roles where possible.
Peter Brummitt, Director, Triumph Research Intelligence
Peter’s GCP expertise spans routine and for-cause investigations across five continents, assessments of vendors and systems (from full-service to niche providers) as well as preparation for, support during and follow-up post regulatory inspections. Peter has supported the training and development of QA professionals across a variety of our customers.
Peter has a particular interest in the alignment of quality management with business risk evaluation as a way to drive improvement in performance and to optimize business opportunities. This has particular relevance to the selection of optimal vendors and how these are managed subsequently