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This course will provide an up-to date overview of the European pharmaceutical regulatory environment, procedures and obligations. You will learn about the legal basis of regulation, development strategies and the strategic importance of pre-submission actions, the format for presentation of data, how the registration procedures work and post-authorisation strategies and obligations.
It will be of value for regulatory affairs personnel and also for those who interact with regulatory personnel in order to understand action timelines and information requirements.
Benefits of attending:
Understand the legal basis of the EU regulatory environment
Discuss development strategy and pre-submission activities
Review procedures for applying for an EU marketing authorisation
Discuss post-authorisation strategic considerations and obligations
