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Boris Romanov
[email protected]
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
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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
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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
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Methods of Expert Evaluation
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Boris Romanov. Expert Evaluation of Medicinal Products. MedChem Russia - 2017