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