ChorichFarm Company offers training sessions in Russian/English on issues connected with obtaining Marketing Authorization for medicinal products. Suggested training programs are made with due regards to specific requirements and are preliminarily approved by Client (description of complete Marketing Authorization procedure, or only part of it related to putting together document package, or training in requirements to RD and IMU drafts, mock-ups, etc.).
|Subject of training||Period|
|Procedure of medicinal products registration in Russia: phases, terms, regulatory documents, brief review of main changes. Registration Dossier structure. Main differences between Registration Dossiers for Russia and EurAsEC||4 hours|
|Introduction of alterations in Regulation documents: types of alterations, approach to Dossier formation. Practical training in the analysis of concrete forms of alterations.||2 hours|
|RD: Rules of drafting and creation. IMU: Principle of creation. Practical training.||3 hours|
Venue: Client office.
Target audience: Specialists, managers engaged in registration of medicinal products, and other interested persons.