Wednesday FoREMS: The REMS Coordination Office
Wednesday, April 14th, 2010
The REMS Coordination Office: Organizing to Effectively Manage REMS
The REMS Coordination Office (RCO) is the organizing hub among a Sponsor’s cross-functional team responsible for various aspects of REMS and the activities of outside vendors and/or agencies. The RCO features a core team of individuals tasked with managing REMS activities and processes. Establishing an RCO allows the cross-functional teams to effectively contribute to REMS while limiting the demand of any one person and/or department. An RCO is one solution for organizing REMS implementation and can be an internal group, outsourced, or a combination of both.
Some of the functionalities and activities of the RCO include:
- Providing objective counsel/guidance for REMS design
- Defining reporting structures and governance to assure appropriate accountability
- Defining the new communications processes across all relevant disciplines
- Developing the essential implementation plan in a collaborative process
- Forming REMS implementation teams, steering committees, and/or designated work streams
- Conducting REMS readiness audits
- Preparing contingencies for FDA questions that may arise
This session of Wednesday FoREMS, includes a discussion by Jeff Fetterman on the structure, responsibility, and functions of an RCO; and considerations for establishing an RCO; with a discussion of case examples by Karen Lenoir, Regina Ruben, and Marc Deluca.
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