Regulatory Affairs/CMC and GMP Inspections in Russia and the EAEU

This online 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. - 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.