OCT is organizing a seminar devoted to the process of bringing medicinal products to the Russian market, starting with pre-clinical studies conduct and resulting in marketing authorization of the drug. This seminar is aimed to inform participants in a detailed way about the up-to-date approaches and peculiarities of the process of medicinal products in-vitro and in-vivo research and drug registration in Russia.
Speakers from the OCT side will be covering core methodologies and principles of pre-clinical and clinical trials program design, and use real-life examples how those approaches are used. Special attention will be paid to the process of drug registration in Russia, which is what OCT does for its clients among other services.
As a full-service CRO, OCT provides support on every step of the clinical trial conduct process, including collection and processing of data derived as a result of a clinical trial which is done by our Data Management and Statistics department, as well as writing final study reports which is done by OCT experienced medical writers.
A separate part of pre-clinical and clinical development of the drug is quality assurance at each phase: an experienced auditor and OCT Quality Assurance Manager Maria Zaitseva will make examples of the most common deficiencies and errors discovered during numerous GCP audits performed.
This workshop will be extremely useful for pharmaceutical and biotechnology companies, as well as for the biomedical start-ups which plan to bring their own medicinal products to the Russian market and are in need of a detailed description of the whole process and advice on their projects. During the workshop, all participants will have opportunities to ask questions of their prime interest and discuss situations they face in their everyday lives.
OCT has the in-depth expertise and resources to help our clients find the best solutions and work out optimal plans of their drugs’ research and development.
OCT will be represented by the experienced specialists from the clinical operations department – Irina Petrova, Head of Clinical Operations, Evgeniya Radkova, Medical Writer; quality assurance department - Maria Zaitseva, Quality Manager; data management and statistics department – Kristina Leus, Director of DataMATRIX (OCT’s recent spin-off).
April 25th, 2014
“Skolkovo” Innovation Center, Hypercube