In 2020, the European Directorate for the Quality of Medicines & HealthCare (EDQM) launched the “CEP of the future” project to design a “new-look” CEP to better meet the current needs of stakeholders, offer enhanced user-friendliness and provide greater information transparency. This project is now being implemented as the “CEP 2.0”. The aim of this webinar is to help CEP applicants and CEP holders to implement any necessary changes in their submissions, to ensure that their applications are processed smoothly. Participants are guided through the revised evaluation procedures (new applications, revisions, renewals) and receive instructions on the information these procedures require. New expectations regarding CEP dossiers are being clarified, and the impact on existing CEPs and ongoing applications are addressed.
The presentation is followed by a question-and-answer session.
This webinar is of interest to CEP applicants, holders and users, including manufacturers and competent authorities.
Download the presentations
- The CEP 2.0 Webinar for CEP holders and CEP users presented by the EDQM
- Introduction to Organisation Management Service (OMS) presented by EMA
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