New IRISS Topic Group: Acquisitions, Mergers & Divestitures (AM&D)

The Acquisitions, Mergers, and Divestitures (AM&D) Topic Group will primarily focus on the discussion and identification of (AM&D) approaches to structured and unstructured documents, data, associated metadata, lifecycle status, publishing information, and global corporate functions impacted by the (AM&D) process:

* Define due diligence required during evaluation phase

* Explore experience of participants and highlight issues, obstacles, challenges associated with (AM&D) activities.

* Utilize and apply defined/published regulatory standards to develop best practices to facilitate the (AM&D) process including but not limited to:

** IT/System Integration/Interoperability

** Procurement/Contracting

** RIM Reference Data Exchange Standards

** Timeline Standardization

** Clinical Data

** Human Resources

* Evaluate the opportunity to influence either standards, organizations, and/or solution providers to develop/alter accelerators

* Facilitate discussions focusing on the interpretation of regulatory requirements from a regulatory perspective and share knowledge of best practices as it relates to (AM&D) activities

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