MCC is excited to have a presence at the eXL 2nd European Clinical Quality Oversight Forum, in London, when Keith Dorricott, MCC Ambassador, co-leads the preconference workshop. The workshop is titled: Aligning to ICH E6 R2: Identifying Critical Variables, Assessing Risk and Defining Control Measures for Aligning With ICH E6 R2 and is on Monday, February 26, 2018 from 8:30 AM –Noon.
Keith and Tammy Finnigan (COO, Triumph Research Intelligence) will work through the practicalities of determining critical data in a protocol, identifying and evaluating the associated risks and ways to control the risks. They will be using ICH E6 (R2) 5.0 Quality Management as the guide.
Keith and Tammy will be providing an approach to each of the steps along with background and examples, such as using the bow-tie analysis to demonstrate how risk events, causes, consequences, preventions and contingencies tie together. The workshop will involve participants working together through a mock protocol with guidance from the workshop leads.
Participants will have the opportunity to share their knowledge and learn from others on aspects of the practical implementation of Quality Management.
For more information or if you would like to connect with Keith, email him at firstname.lastname@example.org.