Tenders Are Invited For Employee Training (Dels)

1. Requirements For The Registration Dossier Of Biosimilars: General Principles. Principles For Establishing Biosimilarity. Preclinical And Clinical Assessment Of The Safety Of Medicinal Products Obtained Using Biotechnological Methods (Basic Requirements), Assessment Of Immunogenicity (At The Stage Of Preclinical And Clinical Trials). 2. Biosimilar (Biosimilar) Medicinal Products Containing Biotechnological Proteins As Active Pharmaceutical Substances. Issues Of Preclinical And Clinical Studies Of Biosimilar (Biosimilar) Drugs: - Biosimilar (Biosimilar) Medicinal Products Containing Monoclonal Antibodies; - Recombinant Erythropoietin;- Recombinant Granulocyte Colony-Stimulating Factor;- Biosimilar (Biosimilar) Drugs Based On Low Molecular Weight Heparins; - Biosimilar (Biosimilar) Medicinal Products Containing Recombinant Insulin And Insulin Analogues;- Biosimilar (Biosimilar) Medicinal Product Of Recombinant Interferon Alpha, Interferon Beta;- Biosimilar (Biosimilar) Medicinal Product Of Somatotropic Hormone;- Biosimilar (Biosimilar) Medicinal Productrecombinant Follicle-Stimulating Hormone (Up To 30 People)