As part of the 9th Pan-Russian GMP Conference with international engagement, three master classes will be held to be dedicated to the functions of qualified persons, licensing issues, as well as the most frequent non-conformities identified during inspections.
One of the hallmarks of the GMP Conference is master classes in the format of business games, which involve the exchange of practical experience between regulators and highly qualified experts with pharmaceutical industry representatives. From year to year, the number of master classes increases. This time, they will take place every day.
The first day of the business program will end with a master class «Qualified persons». Ms. Elena Denisova, Deputy Director of the Department for Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation, will be an expert on the Supervisory Board. The game-based format of the event will allow key personnel of pharmaceutical companies to apply their knowledge of the history of the pharmaceutical industry development, awareness of legislation and its practical application. Three teams of six people will participate in the master class.
Another master class titled «Licensing» is organized by the Department for Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation. Participants will have the opportunity, taking into account their experience in production, to demonstrate their ingenuity, dexterity, knowledge and skills in licensing matters. The master class will provide real-world cases that will help to better understand the regulation and what lies behind its requirements, as well as what happens if these requirements are not met or are incorrectly interpreted.
Traditionally, the third day of the GMP Conference will be dedicated to the «Inspecting» master class. The unifying theme of this event will be the most frequent non-conformities with the requirements of Good Manufacturing Practice identified during inspections. Participants will address cases associated with the most common mistakes that manufacturers make during inspections and will receive comments from representatives of the pharmaceutical inspectorate.
«Master classes, as a form of advancement and continuous improvement of practical skills, allow pharmaceutical companies to consolidate the knowledge obtained in a new format, «look at themselves from the outside», and then apply this knowledge in real life to take their production to a new level. Every year, as part of the GMP Conference, we try to hold such educational events in the format of business games on the most pressing topics that raise the greatest number of questions among pharmaceutical manufacturers. And, for sure, master classes are a platform for open dialogue between regulators and drug manufacturers,» said Mr. Vladislav Shestakov, Director of the Federal State Institution «SID & GP» of the Ministry of Industry and Trade of the Russian Federation, «So, encourage everybody to take advantage of this opportunity and actively participate in all master classes of 2024!»