Pharmaceutical Regulatory Affairs: The European Centralized Procedure (CP)
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Download Saturday, May 16, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline:Introduction: This session provides background information. It specifies the types of product for which the CP is mandatory and those for which it is optional. It discusses the types of Marketing Authorization Application, and characteristics of the application procedure. Procedure: This session takes you through the entire process from pre-submission to what happens after an Opinion has been received. Guidance: This session describes the advice process and provides details on how to receive SAWP advice. | Objectives:Students completing this course should be able to: Provide an overview of the CP process. Identify which products may/must use the CP. For products for which the CP is optional, outline the advantages and disadvantages of the CP compared with other routes to marketing authorization. Describe requirements on content, format and timing of submissions. Describe how to get advice from the Scientific Advice Working Party (SAWP). Specify the sequence and duration of the stages of the CP and the responsibilities of the participants. Describe the role of the European Medicines Agency and its relevant competent committee. Outline fast-track provisions. Describe the appeals procedure. | |
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