Regulatory Affairs/CMC and GMP Inspections in Russia and the EAEU - Regulatory Affairs and GMP Compliance in Russia, Belarus, Kazakhstan and Ukraine
Kurs
In Berlin
Beschreibung
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Kursart
Kurs
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Ort
Berlin
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Dauer
3 Tage
-
Beginn
nach Wahl
- Regulatory framework in Russia, Kazakhstan, Belarus, Ukraine and the EAEU
- Marketing authorisation with a focus on CMC-document requirements
- Variations and change management
- The new certification process in Russia
- GMP inspections in Russia, Kazakhstan and Belarus
Standorte und Zeitplan
Lage
Beginn
Beginn
Hinweise zu diesem Kurs
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.
Meinungen
Erfolge dieses Bildungszentrums
Sämtlich Kurse sind auf dem neuesten Stand
Die Durchschnittsbewertung liegt über 3,7
Mehr als 50 Meinungen in den letzten 12 Monaten
Dieses Bildungszentrum ist seit 16 Mitglied auf Emagister
Themen
- Compliance
- Marketing
- Marketingplan
- Marktchancen
- Marktwirtschaft
- Marktposition
- GMP
- EAEU
- Marketing Trend
- Märkte 2020
Inhalte
- 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.
- Day three will provide you with in-depth knowledge on the current requirements for GMP inspections by local authorities in Russia, Kazakhstan and Belarus. You will be able to prepare for and pass these GMP inspections, and you will know what Russian GMP inspectors expect.
Regulatory Affairs/CMC and GMP Inspections in Russia and the EAEU - Regulatory Affairs and GMP Compliance in Russia, Belarus, Kazakhstan and Ukraine