This course, a Thomson Reuters Cortellis Regulatory Online Learning module, covers how to register a pharmaceutical using the centralized procedure. It details the products the procedure applies to and the steps that need to be considered in the pre-submission phase. Participants learn the administrative aspects of a submission and the procedural steps that need to be completed, from day 1 to day 210. The course concludes by reviewing the procedure’s decision-making process and the main post-authorization activities.
Register a pharmaceutical using the centralized procedure
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Participants who complete this course should be able to:
- Identify the legal basis and scope of the centralised procedure
- Describe the procedural and administrative aspects of a submission
- Clarify the aspects related to the quality section of the dossier
- Outline the steps to take before the procedure commences
- Review the steps and actions taken from Day 1 through Day 210 of the review process
- Explore the aspects taken in the decision-making process
- Identify the main post-authorization activities
The course takes an average of two hours to complete.