All Regulatory submissions articles
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JournalNavigating regulatory scrutiny: An analysis of requests for information in EU combined clinical trials
This article explores aspects of IVDR and how to implement these during clinical trial processes including submissions.
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JournalNavigating the landscape of paediatric clinical trials under US FDA guidelines
This article explores paediatric clinical trials under the guidelines of US Food and Drug Administration (FDA) legislation, focusing on research development and ethics.
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FocusThe changing role of regulatory operations
The regulatory profession has always attracted diverse individuals with a wide range of professional experiences. Top talent has migrated from preclinical labs, clinical operations, quality, and a range of functions to pursue a career in regulatory operations. The role of the regulatory operations professional has and continues to evolve as the requirements for the position have changed drastically. These professionals have witnessed a substantial change in the responsibilities associated with their role. These changes are directly related to those in global submission requirements and associated standards, emerging technologies, and shift ing resourcing models, among other factors.