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April 14, 2010

Wednesday FoREMS: The REMS Coordination Office 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

Wednesday FoREMS discussion

April 14, 2010 at 12:00 PM Eastern Time

The REMS Coordination Office (RCO): 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

If you have not yet registered for the Wednesday FoREMS series, follow this link: Wednesday FoREMS Registration.


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