20.Sep.2016

OCT to hold the 4th Annual Conference: 4 hours, 20 speakers, 300 guests

The 4th annual conference “Clinical Trials In And Outside Russia” was held by ОСТ last Wednesday, September 14, 2016. This time the event brought together about 300 clinical research professionals.

Apart from the representatives of pharmaceutical companies, R&D establishments, development institutions, and investment funds, among the conference speakers there were specialists of FSBI “SCEEMP”, Eurasian Economic Commission, and FSBI “CMCEE” spoke at the Conference: Dmitry Goryachev, Dmitry Rozhdestvenskii, Igor Ivanov, and Marina Sergeeva.

The 4 panel discussions covered the following issues:

  • Clinical trials today and tomorrow: the speakers discussed the legislative requirements of the EurAsEC, aspects of pivotal clinical studies, issues related to updated ICH GCP guidelines, CORE Reference for reporting, and other trends.
  • International development of Russian pharmaceutical projects: the renowned Atlas oncology diagnostics project and interaction between pharmaceutical companies or investors and biotech startups were used as examples in the discussion of challenges related to the entry of Russian projects into the international market, its competitive landscape, and new opportunities provided by development institutions.
  • Qualitative data for successful start of a clinical trial: the issues discussed included planning and starting of a clinical trial in terms of clinical data management (CRF development, patient randomization, work of biostatisticians during study startup, and challenges faced by pharmaceutical companies or CROs). Further emphasis was placed upon the latest changes in the Russian legislation, which now regulates the quality of services provided by clinical data management vendors. 
  • Registration of medical devices: the discussion covered recommendations and outstanding issues related to registration and classification of medical devices. A complex approach to the registration strategy was discussed as part of a case study on additive technologies (3D printing of joints). During the session over 30 participants’ questions were discussed.

Dmitry Sharov, OCT President: “It is great that we’ve managed to expand the conference discussion and to secure the participation of many subject matter experts as speakers. For us, this annual meeting is not only an opportunity to share the most up-to-date information with our colleagues, but also a discussion platform and a chance for active industry participants to consider all important issues together.”

The conference was organized by: ОСТ, Data MATRIX, Primer Capital, ReCon.

Follow the link to see the event gallery.