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The Introduction to European Regulatory Affairs conference provides you with a clear understanding of the EU regulatory structure and ensures your submissions meet the standards required by the regulators.
The three day Introduction to European Regulatory Affairs conference is designed to give you new strategies to improve your regulatory affairs activities and optimise drug submission procedures. Some of the many topics that will be discussed include compiling a drug registration dossier: a practical and detailed analysis of what information is needed and how to present it; clarifying the obligations of the marketing authorisation holder; mastering specific regulatory areas: post-approval obligation, variations, and clinical trials requirements; working effectively with the EMEA; and many other key topics.
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