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Approach ICH-M2 seeks multinational agreement on recommending electronic standards and solutions for industry and regulators.
The establishment of common standards, especially at the international level, is a long, expensive, and complex process. This is mainly due to these fundamental needs:
The M2 EWG has gone to great lengths to ensure that, despite their disparate needs, the different regions come to a consensus before those needs are factored into the recommendations.
ICH M2 EWG pursued the challenging task of recommending international solutions by identifying the key areas (domains) that demanded M2's immediate attention. ICH M2 EWG concluded that the best approach would be to recommend a technological framework consisting of open international standards and inter-operable products, or to identify proprietary solutions that are de facto standards, since the products offer all the required functionality. The process of developing the technological framework and recommending solutions followed the logical path of gathering requirements, assigning specific tasks, evaluating international standards and products, and recommending a functional architecture. Main | Background | Objectives | Approach | Recommendations Functionality | Meetings | Glossary | Future | Contacts
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