On February 25, 2015 OCT and ReCon held the conference to review the latest legislative changes and their influence on pharmaceutical companies. The event gathered approximately 200 professionals among which were executive officers and employees from 96 pharmaceutical companies and developers of medicinal products, members of regulatory, medical, QA and business development units.
The first part of the event was focused on the selection of registration strategies in light of changes introduced to Federal Law No. 61-FZ and new EEU legislation. ReCon General Director Anna Astakhova shared her vision on these changes: “We live in times of regulatory and legal changes and thus it can be expected that over the next few years a number of mechanisms for launching new medicines into the market will appear both in Russia and in Eurasian Economic Union (EEU) member states. We cannot deny that there are still a lot of open questions, as the Russian legislative changes introduced from January 1, 2016 are not applied in practice yet and the new EEU registration procedure has also not come into force yet due to a number of unapproved regulations.”
R-Pharm Chief Medical Officer Mikhail Samsonov took part in the Q&A session at the conference: “We see that the pharmaceutical community, particularly the legal support service, is very interested in the legislative changes. It is not surprising as they aim to provide people with all the necessary range of modern medicines which are both effective and safe, and are registered in accordance with applicable laws.”
During the second part of the conference, Irina Bondareva, biostatistician at the Federal Medical & Biological Agency of Russia, Scientific Research Institute of Physical-Chemical Medicine, and Eugenia Radkova, medical writer at OCT, discussed the current situation and trends in the development of clinical trial design, medical writing, statistical planning, and analysis of results. The conference introduced the participants to observations on clinical trial protocols and the list of new types of documents required by the latest legislative changes. The discussion of statistical aspects of adaptive designs, which are becoming more and more applicable both in Russia and abroad, evoked great interest in the audience.
Unfortunately, the conference hall could not accommodate all those wishing to attend the event this time. Please contact us to resolve any outstanding issues: email@example.com