29.Apr.2014

OCT has successfully conducted a workshop on practical aspects of clinical development at the Skolkovo Innovation Center

April, 25-th, OCT team spoke at the workshop “Bringing a drug product to the market: from pre-clinical to registration. Practicalities”, organized in joint with the Cluster for Biological and Medical Technology of the Skolkovo Fund.

The workshop has gathered representatives of the pharmaceutical and biotechnology companies, as well as the biomedical start-ups planning to bring their medicinal products to the Russian market. More than 80 participants attended the event to listen to the presentations of the speakers who tried to cover the most vital topics and observed efficient balance between the important theoretical and the applicable practical parts in their speeches.

audience

The seminar was opened by a leading researcher of the Institute of public health of the Russian Academy of Sciences professor Elena Telnova who has held a speech on the regulatory part of the drug registration process in Russia, current problems and perspectives of the issue.

OCT experienced executives joined in with their in-depth presentations and expert views on the whole process of drug research – starting from the legal environment in Russia and the problem of harmonization of the Russian and the international requirements for clinical trials conduct, and pre-clinical program development (Maria Zaitseva, Quality Manager, auditor, MRQA*), moving to the clinical studies design and elaboration (Evgeniya Radkova, Medical Writer)and clinical trials organization and conduct (Irina Petrova, Head of Clinical Operations), data management and statistics (Kristina Leus, Director of Data Matrix**), and up to the most frequent and interesting findings during the audits conducted in the process of clinical research. The workshop was moderated by Elena Startseva, OCT Head of Business Development.

sk

It was a pleasure for OCT team to receive positive judgments and words of respect and gratitude from the people who took part in the workshop. We are happy that the knowledge we shared with the participants was useful and the topics we covered found keen interest among the audience.

This was for sure not the last event of such type that OCT organized in joint with the Cluster for Biological and Medical Technology of Skolkovo Fund – next time we will devote a similar workshop to the topics no less urgent for our audience, and we will be happy to receive requests and comments from the participants regarding the themes they would like us to cover next time.

You are welcome to send your comments and request to

Anna Yanaeva,  
Business Development, Associate  
ayanaeva@oct-clinicaltrials.com

* Mass rearing and quality assurance

**Data Matrix is a subsidiary in OCT Group Holding