A workshop on pharmacovigilance in Russia and the EurAsEC was held by ReCon on December 10, 2015. The event gathered around 80 participants including representatives of pharmaceutical companies (members of registration, pharmacovigilance, QA, medical and clinical departments), distributors and developers of medicines.
ReCon Managing Partner Anna Astakhova provided an overview of requirements for pharmacovigilance system, key features and challenges of its establishment and functioning in business entities. Two regulatory documents governing pharmacovigilance in Russia and the EurAsEC are currently in their final stage of approval. Despite the fact that their final versions are not available as of now, starting from January 1, 2016 the changes will be enacted and apply to every company operating in Russia. Invited experts Ekaterina Andrianova (ОСТ) and Kristina Leus (Data MATRIX) shared their visions on the means of complying with pharmacovigilance requirements both from the standpoint of a clinical trial provider and that of a software solution provider for the industry. In particular, Kristina Leus spoke of the development of a new pharmacovigilance software module as part of the MATRIX Cloud system.
“Many aspects of setting up a pharmacovigilance system have sparked an active discussion among the participants. It was a remarkable experiment, as they could not only enrich their theoretical knowledge, but also share their experience and obtain answers to their questions. We thank all our guests for friendly atmosphere and their active participation. Next year we also plan to hold workshops on the most current issues for industry experts,”