Don’t worry, we’re not talking Shakespeare and it’s ‘B’ for baselines – we want to help you understand when a baseline might be required and what it should contain. From January 2019 the EU eSubmissions Roadmap will mandate the use …
With a background in analytical chemistry and operational leadership I am now the performance manager of a team of scientific classifiers in the Information Processing Unit within the Transformation Division at MHRA. The team is responsible for the technical and content validation of submissions in a high throughput, fast paced environment and provides resolution of eSubmission and validation related queries.
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An official blog of the Medicines and Healthcare products Regulatory Agency (MHRA), providing expert insight on the latest regulatory thinking and all aspects of medicines regulation.