The first part of this module explains how to build a good application for a new CEP and how to avoid deficiencies. The module is based on the top 10 most frequently asked questions after the initial evaluation of new CEP applications, along with expectations and recommendations on how to address specific deficiencies with reference to applicable guidelines. It is intended to help applicants to improve the quality of their dossiers, in order to facilitate and speed up the granting of a CEP.
The module also includes an introduction to preparing a revision application, provides an explanation of the basic principles for maintaining a CEP, the content of a revision application and the EDQM timelines for assessment. Participants are guided through the types of changes with examples and the supporting documentation to be submitted. The recording includes a Q&A session.
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Target audience
The module is of interest to all personnel involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.
It is ideal for those looking to build a solid foundation knowledge of both the Ph. Eur. and the Certification procedure, for example, newly graduated or early-career professionals.
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Duration: 1 hour, 45 minutes. |
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- How to build a good new CEP application, by Alma Kiso
- Introduction to preparing a revision application, by Paulina Gondek
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