Global CMC Requirements - Quality data for marketing authorisations outside the ICH region
- Quality data for the dossier - you have to display the data in this format
- Pharmaceutical documentation for Latin America, Russia and Asia - how to fulfill the CMC requirements
- Import testing - country-specific requirements
- Global stability programmes - this stability testing is essential for worldwide registration
- How to manage the CMC lifecycle
This seminar will focus on the CMC
requirements outside the ICH region.
Which data and which formats have
to be provided for a marketing
authorisation?
Two CMC experts will give you a detailed
overview of the general requirements
and pass on their in-depth knowledge of
the Latin American, Russian and Asian
markets.
After attending the seminar you will have
a good understanding of your CMC duties
in the various regions and will have new
input on how to set up global stability
programmes.
Termin
| Datum: | 07.07.2016 |
| Ort: | Capri by Fraser Europa-Allee 42 -60327 Frankfurt |
| Preis: | 990,00 EUR zzgl. MwSt. |
Zielgruppe
This seminar addresses the needs of
those working in the pharmaceutical
industry. It will particularly benefit
those dealing with international
CMC topics, such as
- CMC managers
- Regulatory affairs managers
- Managers of the
quality assurance department.
Kontaktinformationen
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