Expert Evaluation of Medicinal Products

Romanov B.K. Expert Evaluation of Medicinal Products «НЦЭСМП» 2017.

Transcript

1. Boris Romanov Romanov@expmed.ru Expert Evaluation of Medicinal Products Federal State-Funded Institution «Scientific Centre for Expert Evaluation of Medicinal Products» under the Ministry of Health of the Russian Federation
2. 2 Boris Romanov. Expert Evaluation of Medicinal Products. MedChem Russia - 2017 Life Cycle of Medicinal Products Development steps: 2016-2021 3. Clinical trial Dossier Expert Evaluation of Medicinal Products Ministry of Health of the Russian Federation 5. Registration / confirmation Ministry of Health of the Russian Federation 4. Samples of medicinal products 2. Preclinical trials (studies) Report Ministry of Health of the Russian Federation Permission to conduct the clinical trial Report Dossier Ethical Review 1. Development of new molecules & technology
3. 3 Expert Evaluation of Medicinal Products  Expert evaluation of preclinical studies results and documents for conducting clinical trials in Russia (including IMCTs).  Examination of drug authorisation documentation and post-authorisation changes (quality, efficacy & safety).  Documentary and laboratory expert evaluation of drug quality during authorisation  Evaluation of interchangeability (“Russian “Orange Book”)  Maintenance of the Drug Register in Russia  Certification of immunobiological drugs  Scientific activities: research, development of monographs and other texts for the Russian Pharmacopoeia, publication of three scientific journals  Educational work Boris Romanov. Expert Evaluation of Medicinal Products. MedChem Russia - 2017
4. Methods of Expert Evaluation 4 Boris Romanov. Expert Evaluation of Medicinal Products. MedChem Russia - 2017