COREX team has long been looking for a suitable platform where pressing issues faced by our industry can be freely discussed. Finding none, we have decided to create our own venue that would allow for exchange of ideas and sharing of experience on the most relevant topics. The selected format was the product of our desire to combine the formal setting of structured presentations by industry’s key opinion leaders with the informal atmosphere of a breakfast with colleagues.
The first speaker, Dmitry Goryachev, Director of the Center for Evaluation and Control of Medicinal Products, FSBI “SCEEMP” of the Ministry of Health of Russia, presented the regulatory authorities’ perspective on how the processes connected with drug circulation across the countries of the Eurasian Economic Community (EEC) will be shaping up based on new regulations that are now being ratified. His speech was very well received and during the ensued break a large queue of attendees formed to ask Dr. Goryachev one on one questions.
Igor Stefanov, General Manager of Synergy Research Group, outlined the major risks that the CROs face while outsourcing important clinical trials to logistics operators. The representatives of pharmaceutical companies agreed that risk mitigation is a very important part of any clinical trial and that advanced planning is the best approach to risk minimization.
The guests highly appreciated a presentation by Vitaly Shakhnazarov, COREX director of quality assurance. Vitaly introduced application of such analytical methods as GAP and SWOT which can be used as potential risk assessment tools; he likewise emphasized the key role of understanding the nature of anticipated risks at every stage of project planning. After his speech, Vitaly answered the questions that were mainly related to risk minimization at the stage of project launch and at subsequent stages of a clinical trial. These questions clearly demonstrated the pressing nature of the issues of quality assurance in clinical trial logistics.
The last presentation of the “Breakfast with a Logistician” was given by Roman Golubev, a recognized expert in insurance of temperature-sensitive cargo from “INGOSSTRAKH” company. Roman explained the fundamental aspects of insurance of such cargos and provided several valuable examples from his rich 12-year practice which very much captivated the audience.
The event was visited by the journalists from specialty media who found the topic of risks associated with temperature-sensitive cargos particularly meaningful to their readers. The flexibility of the business-breakfast format appeals to its attendees. After each event, we ask our guests to complete the questionnaires and provide their feedback regarding any changes to the event format they might have and which questions they would like to discuss at the next meeting. We, in turn, will continue to do our best to analyze all the feedback and organize subsequent events accordingly in hopes that our “Breakfast with a Logistician” continues to bring real value to the experts engaged in clinical trial logistics.
The pharmaceutical industry has faced numerous challenges since the beginning of 2021 including the rush to supply COVID-19 vaccines. The start of the year also saw the departure of the UK from the EU and theEuropean Medicines Agency (EMA). The Medicines and Healthcare Products Regulatory Agency (MHRA) is now fully in charge of all regulatory matters, oversight of clinical research and approval of medicines.
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