RAPS US Convergence

Developing an IDMP Change Management Programme

This session will provide a high-level review of the organizational impacts, workstreams and actions that should be considered as part of a change of control program for the implementation of IDMP

September 14, 2021
1:30PM-2:15PM EST


Karen Harry image

Karen Harry

Director Regulatory Information, RIM Consulting, Calyx

Karen Harry has extensive industry experience in Regulatory Operations and Regulatory Information Management particularly in the implementation of regulatory processes and compliance with regulations. In her current role at Calyx, she leads a team of Regulatory Consultants who provide strategic regulatory input into the RIM software development lifecycle and supports clients with their subject matter expertise to effectively manage complex regulatory processes, in alignment with the changing regulatory landscape.

Karen is a member of the IDMP/SPOR Task Force within the PMS group in addition to participating in several working groups including SPOR PMS, IRISS and a Focus Group for Process looking at the TOM for step 1.

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