Межотраслевое объединение Фармпробег | Workshop at the Federal State Budgetary Institution of Technology of the Russian Federal Medical and Biological Agency Day 1. GLP and communications

Workshop at the Federal State Budgetary Institution of Technology of the Russian Federal Medical and Biological Agency Day 1. GLP and communications


From July 29 to August 1, 2019, the first module of the series of seminars “Continuity and Consistency of GxP in the Pharmaceutical Industry” was held at the Federal State Budgetary Institution of Medical Technologies of Russia. The goal of the project is to familiarize participants with the system of good practices and connect them with the communication environment. Within the framework of the first module, participants plunged into the GLP (Good Laboratory Practice) system of norms and learned the basics of building effective communications in the professional community. We present to your attention a material devoted to the first day of the past event.

The start of the project on July 29, 2019 was marked by the participation and support of honorary project participants. So, the welcoming remarks were made by: Maxim Ivanov, Director of the Federal State Budgetary Institution of Technology of the Russian Federal Medical and Biological Agency and Dmitry Chagin, Chairman of the Board of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union. Honorary participants noted the importance of this initiative, especially in the context of creating a professional communication environment in the direction of exchange of experience between representatives of different institutions. Indeed, the event was able to bring together representatives of such structures as: Federal State Budgetary Institution for Science and Technology of the Federal Medical Biological Institute of Russia, St. Petersburg Research Institute of Medical Biology of Russia, the Federal State Budget Scientific Institution Scientific Research Institute of Medical Primatology, and the Federal State Budget Scientific Research Center for Oncology named after N.N. Petrova ”, contract research organization X7 Research.

After greeting the honorary participants, Alisa Belskaya, head of research at the Testing Center for Preclinical Research of the Federal State Budgetary Institution of Medicine of the FMBA of Russia, MD of the Laboratory of Drug Toxicology, who made a presentation on “Good Laboratory Practice as a Project for the Implementation of Export Activities on the Basis of the Federal State Budgetary Institution of Medicine of the Russian Federal Medical Academy,” took the floor. . At the end of the presentation, participants visited the preclinical research test center accredited in accordance with OECD GLP standards. Today, the staff of the testing center includes forty-one employees, among them – 7 doctors of sciences and 10 candidates of sciences in the field of pharmacology and toxicology. In the period from 2014-2018. 154 studies were carried out at the center: 40 projects of foreign manufacturers, 114 projects of Russian manufacturers.

Participants of the tour were convinced in practice that GLP is a lifestyle. GLP is a reliable future. GLP is a circle of trust in product safety. A solid bridge between good manufacturing and clinical practice.

Then, after the completion of the GLP block, an intensive course on the theory and practice of communications began, led by Anna Plesovskikh, a business trainer, the head of the intersectional association “Pharmprog”. First of all, the participants examined the basic concepts and determined how communication differs from the communication process, realized how you can be a great conversationalist, but a bad communicator and vice versa. In addition, the training participants identified the purpose and types of communications, learned the basic classification of communications and went through 8 steps of the communication process.

During an active discussion, one of the training participants admitted that she had avoided public speaking all her professional activities, as she had a strong fear of the audience. As the main reason for this block, the participant identified the fear that the listeners of her performance may be more knowledgeable and professional than herself. To the question “Does she love her job?” The participant was inspired and shared her love for her work, talked about how she was passionate about her profession. The only thing left is to overcome the communication barriers that the training participants worked on throughout the afternoon of the first day course.

First of all, participants learned the nature of fears that lead to communication barriers. We discussed the concept itself and the factors that impede communication, and also listed all possible communication barriers and worked out in detail communication barriers in the context of cause-effect relationships. Using the fear of public speaking as an example, the group worked out its own picture of the world in terms of fear of external evaluations and received the basic techniques and keys to overcome internal fears.

To consolidate the topic of “communication barriers”, the training participants went to the FlyArena complex in St. Petersburg, where an aerodynamic simulator with an experienced staff of trainers in flight training in a wind tunnel is located. The unique free fall simulator allows you to experience the same sensations as when jumping with a parachute, which is an excellent way to overcome communication barriers – the most important thing is to decide to take the first step into the unknown and “jump” into your own fear. It is this step that allows you to start working with internal attitudes and familiar patterns of thinking.

“For me, the flight was scary at first, but with the first positive result, there was confidence that everything would work out. There was enough time and approaches to repeatedly consolidate a positive result and begin to enjoy the process. Thanks to the hints of more experienced colleagues and their support, everything worked out! ”Said the training participant Alla Panchenko, head of the quality assurance department of the FSBI NII MP (Sochi).

In turn, experienced FluArena instructors noted the high degree of training of the group of beginners of the training: “Everyone flied without exception as if they already had flight experience. It pleasantly surprised me. Perhaps just the training helped. Well done, ”commented Vlad Takhtarov, instructor of the FlyArena complex.

“I’m sure that two factors influenced this result. Firstly, the amazing experience of the instructors of the complex, which, in my opinion, is of paramount importance. And secondly, a deep study of communication barriers and mechanisms for working with the world picture, which contributed to the formation of internal readiness for flights, ”said Anna Plesovsky, the host of the training.

The following materials will provide details of the next days of the event, as well as the effect of the work done on the first day of the training. To be continued.