How Mergers & Acquisitions Impact Regulatory Operations Part II

Executive management may consider creating a strategic plan for in/out-licensing and mergers and acquisitions. This strategic plan should include the technical aspects of such an undertaking. Such topics as systems to be used, network and security, and staff involvement (including when to involve staff) are important strategies to ensure success.

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EDM Reference Model Metadata and eCTD Submissions

Many of you are no doubt familiar with the EDM Reference Model. This is a cross-SIAC initiative by the DRM (Document and Records Management (DRM) SIAC. [A SIAC is a Special Interest Area Community within DIA.] As a quick refresher, the goal of this group is to define a minimum set of metadata to enable the context of use of regulatory submission for CTD documents and supporting documents. In other words, what metadata should be used...

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