This Live Online Training has been developed for all who are dealing with API Sourcing, Manufacturing, Quality Assurance and Regulatory Affairs.
Objectives
This Live Online Training is intended to provide guidance on the format, content and submission procedures for drug substances within the newly implemented CEP 2.0.
You will be informed about the following topics linked to the CEP 2.0:
What’s new? Comparison of CEP and CEP 2.0
What’s expected by the authorities?
How to obtain a CEP 2.0?
How to use a CEP 2.0 outside and inside Europe?
Background
The implementation phase of the new CEP 2.0 was finalized in 2023 and replaced the formerly valid CEP (Certification of Suitability). From now onwards, applicants of a new dossier or renewals will receive a CEP 2.0. This will be available as a PDF file in the so-called sharing tool “DCEP” and will be signed electronically only. For revisions, that affected the content of the CEP, a so called “Hybrid CEP” will be issued. A switch from a valid CEP to a CEP 2.0 is now also possible for CEP holders.
Programme
EDQM's View on the CEP 2.0
Why do we need the CEP 2.0? What is new?
Cooperation with other authorities
Outlook to the future
How to obtain a CEP 2.0 and how to deal with the Users
What information is specific for the CEP 2.0?
Information to be provided to the customers
Wishful thinking about the future
National Competent Authority´s View on the CEP 2.0
Experiences with the new CEP 2.0
Are the current processes working?
Pitfalls
How to use the CEP in the Marketing Application in and outside of Europe
How to use the CEP 2.0?
Obtaining information from the holder of the CEP
Using the CEP outside of Europe
Further Information
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Testimonials
