What is in the Programme of V GMP-conference?
On the official site of V All-Russia GMP-conference with international participation published a business program of the event. Thanks to the online format, Conference organizers were able to ensure the participation of the representatives of regulatory agencies of Italy, Hungary, Japan, UAE, Saudi Arabia, India, Spain, Bosnia and Herzegovina, USA, Jordan, Croatia, South Korea, France, Azerbaijan, the EAEU and the EDQM, who on 30 September will discuss the lessons learned from the pandemic and exchange perspectives of working in the conditions of a new reality.
Today the organizers of All-Russia V GMP-conference have made the program of the Conference, which will be held under the motto “Common GxP Rules – Quality for the greater health”, publicly available. Over the period of 5 years GMP-Conference has been consistently expanding not only the geography of participants, but also the number of practices, falling under the orbit of discussion. Program of the Conference covers all issues related to quality of drugs, access to them, efficacy for patients, and the online format of this event has enabled to bring the speakers from different parts of the world.
This year the Ministry of Industry and Trade of the Russian Federation in conjunction with State Insitute of Drugs and Good Practices proposed to regulators and representatives
of pharmaceutical companies to dedicate the Plenary session not just to the subject, which is not coming off front pages of media agencies, but to the lessons learned and development of effective mechanisms that hinder proliferation of global threats and destabilization of working processes.
“Special conditions of work”, that all have encountered, are changing the traditional aproaches and accustomed ways. State Insitute of Drugs and Good Practices of the Russian Ministry of Industry and Trade, as most of the GMP inspectorates under the impact of COVID-19, has begun to use the mechanism of remote inspections of foreign manufacturers of drugs for human use, taking into account the submitted documents and risk-based evaluation of a site, and from the month of May became the first to conduct to online-inspections. Such transformation has led to the idea
of changing the format for the most popular and anticipated by the participants GMP master-class, – reveals the Director of State Institue of Drugs and Good Practices Vladislav Shestakov. – We are going to depart from standard “question-answer” style or pre-prepared presentation by an inspections on the most frequently identified non-conformities during inspections in the past year. Instead of this there will be a lot of practicial content, thereby making the session a “two-way street” . This also includes a quiz “Walk in inspector`s shoes”, and a real time preparation of an inspection site for conduction an inspection. With the help of factories, which had successfully passed inspection, our inspectorate modelled some situational video-tasks, by solving which, the participants will be able to test themselves through identifying hidden non-conformities. And
the master-class will be concluded by an online inspection. On the whole there will be many non-standard and interesting moments, which will not allow the audience to be indifferent and unengaged”.
The subject of a single market EAEU has also not been overlooked by the organizers of the GMP Conference. There are two sessions dedicated to this issue. Currently the Ministry of Industry and Trade of the Russian Federation is activiely involved in alignment of the national legislation with the GMP rules of the EAEU. The work of joining the PIC/S is still underway. In the EAEU itself the issue is being increasingly raised on the necessity to establish integration mechanism for the earliest possible implementation of the single market functioning. These issues will be the subject of a discussion between regulators of all the EAEU member-states and pharmaceutical manufacturers that issue and market their products in the Eurasian market.
What else interestesting is there in the program?
- Virtual meetings with trade representatives of the Russian Federation in Latin America, Asian and Pacific region, Africa and Europe, which will present an overview and current state
of the pharmaceutical markets, speak about the countries’ demand for drugs, Personal Protective Equipment (PPE), vaccines and medical devices at times of the pandemic, and also provide practical recommendations on entering the pharmaceutical market of those countries.
- Discussion devoted to overcoming dependency of the pharmaceutical market on the supplies from Southeast Asia.
- Roundtable on further education and training of specialists in the pharmaceutical industry.
- Good Pharmacy Practices in the Eurasian Economic Union (EAEU) in the fields of GLP and GDP.
- Current trends in global legislation and global harmonization.
- Roundtable dedicated to technological solutios of “continuous manufacturing”.
- Special session on immunobiologicals and much more.
The program of the 5th All-Russia GMP Conference with a full list of participants and their presentation topics can be viewed here: http://gosgmp.ru/en/conference-program/
Time period of the Conference: 30 September – 1 October.
The General partner of the Anniversary V GMP conference is MSD Pharmaceuticals,
the strategic partner this year is Gedeon Richter and the official partners are Teva and Astellas Pharma. The conference is supported by companies such as R-Pharm, Novartis Group in Russia and Pharmeco. Several companies chose to support more attractive sessions for themselves of the Anniversary V GMP conference: PRO.MED.CS Praha a.s., Pharmasyntez, Akrikhin and Nanolek. The special partners of the event are Abbott and Nacimbio.
- The contest «The best Technical Director» has been announced
- FSI “SID & GP” of the Russian Ministry of Industry and Trade shared its perspectives on conducting GMP inspections in the conditions of aseptic process with the Institute for Medicines and Medical Devices of Montenegro during an educational webinar
- Summing up the results of International Student Festival “GxP-Fest”
- Vladislav Shestakov: GLP system must be viewed by the pharma in a common set with all good practices”
- Commencement of International student festival GxP-Fest