Pharmaceuticals - Regulatory Guidelines
In major commercial territories across the world including the European Union, the United States, Japan and elsewhere, national health authorities are requiring or strongly recommending the delivery of product information in standards-based formats in order to facilitate faster review and approval/revision and to speed the delivery of products and product information to the public. Examples of these types of new guidances include Product Information Management (PIM) in the EU and Structured Product Labeling (SPL) in the U.S.
Underscoring this movement in product information, there is also a global movement toward the submission of all medicine approval information using standards-based XML technology. This is perhaps best characterized through the work of the International Committee for Harmonization (ICH) and it’s initiative to standardize the format and content of marketing licenses for new drug introductions through the universal application of the electronic Common Technical Document (eCTD).
CSW's Knowledge Management Suite (KMS) is similarly well positioned as a tool to help pharmaceutical companies achieve this goal both in the EU and US.
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XML-based Knowledge Management Suite |
Cross-Agency, Shared-Care Electronic Health Records |
Improves Bed Management & Reduces Average Length of Stay |
