Regulatory Affairs/CMC and GMP Inspections in Russia and the EAEU - Regulatory Affairs and GMP Compliance in Russia, Belarus, Kazakhstan and Ukraine

- National registration in Russia, Kazakhstan, Belarus and Ukraine
- Marketing authorisation with a focus on CMC-document requirements
- Regulatory and GMP compliance
- GMP inspections in Russia, Kazakhstan and Belarus
- Handling regulatory non-compliance in GMP inspections

This seminar provides you with in-depth knowledge on the current challenges when applying for a new marketing authorisation, as well as the maintenance activities and challenges of GMP inspections in EAEU countries.
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After having attended days one and two, you will be aware of the dossier requirements for Russia, Kazakhstan, Belarus and Ukraine, particularly with regard to CMC. You will also be able to prepare the CTD dossier, especially Module 3 and the Normative document for Russia. Moreover, you will be familiar with the change management requirements to achieve regulatory and GMP compliance.
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Day three will provide you with in-depth knowledge on the current requirements for GMP inspections in Russia, Kazakhstan, Belarus and other EAEU countries. You will be able to prepare for and pass these GMP inspections, and you will know what Russian GMP inspectors expect.

Termin

Datum: 03.06.2019
Ort: NH Frankfurt Airport
Mörfelder Str. 113
-65451 Frankfurt
Preis: 0,00 EUR zzgl. MwSt.
 

Zielgruppe

This seminar is primarily intended for those:
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- dealing with regulatory affairs/CMC in EAEU countries (Russia, Kazakhstan and Belarus in particular) and/or Ukraine; and
- preparing for and/or attending GMP inspections in these countries.
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Regulatory affairs, CMC, quality and business development staff will particularly benefit from this seminar.
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All registered participants are welcome to send their questions to the speakers prior to the seminar.

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