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Posted 01 September 2010
This issue of Regulatory Focus features our changing regulatory environment, specifically, recent changes taking place in Europe.
Ever-proliferating and changing global regulations generate complex challenges of execution in global market clearance operations. Such changes can critically impact executive decision making, regulatory process workflow and corporate governance. The lack of clarity regarding evolving regulations can cause delays in product release and market supply decisions, ultimately resulting in delayed or lost revenue. Regulatory process workflow issues can arise as a result of conflicting information from distributors, regulators and legacy resources as they are reconciled and definitive answers sought. Governance can be compromised as information gaps reduce assurance levels and impair management's ability to conduct compliant market clearance operations.