10:00–11:30
M15
Session 1: Regulatory Cycle of Innovations: Clinical Trials, Registration, HTA, Pricing, and Patient Access – A Dialogue with the Regulator of the Russian Federation and the EAEU
- Regulatory aspects of clinical trials and drug registration
- GMP/GCP inspections as an element of trust in the manufacturer
- Exchange of experience in the field of health technology assessment (HTA)
- Pricing practices for innovative and orphan drugs
- Criteria and procedures for inclusion in formularies and the drug supply system
- Introduction of Russian drugs to the Chinese market; opinion of the Chinese regulator regarding the inclusion of the Russian Federation in MRCTs (Multiregional Clinical Trials) for the purpose of obtaining data for subsequent registration in the EAEU