Marieke van Dalen
MARA Consultancy
Referent:innen
Cristina Jimenez Sala
Centrient Pharmaceuticals
Andrea Melloni
COUNCIL OF EUROPE - EDQM & Healthcare
Olaf Ludek
IMA Icelandic Medicines Agency
All times mentioned are CEST.
Zielsetzung
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:
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?
Furthermore, you will have the opportunity to reach clarification on ambiguous issues by bringing your questions up for discussion. Take advantage of the experiences of our speakers and send us your questions and challenges prior to the Live Online Training.
Hintergrund
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.
Zielgruppe
This Live Online Training has been developed for all who are dealing with API Sourcing, Manufacturing, Quality Assurance and Regulatory Affairs.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
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
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
Sonderkonditionen DB BahnTeilnehmerstimmen - das sagen andere über unsere Seminare:
