REGLEK
11 – 13 November
At the “Harmonization and Transition: Challenges and Solutions” session, Elena Popova, representing the AIPM, presented the Association's 2024 study on aligning with the legal framework of the Eurasian Economic Union (EAEU) to the regulators of the EAEU countries. Over 1,800 regulatory approvals have already been transitioned to the new regulations or are in the process of transition. Industry professionals and regulators discussed current procedures, methods for optimization, and adjustments to the regulatory framework. Anna Lakhtanova, Chair of the AIPM Regulatory Affairs Committee, highlighted the issues of mutual recognition and overcoming regulatory barriers during the session titled “You Can't Refuse to Admit — Where Should I Put the Comma?”. At another session focused on pharmaceutical inspections, participants reviewed legislation and current issues related to good practice inspections (GCP, GVP, GMP). Almira Galeeva, representing the AIPM, discussed the practical aspects of pharmaceutical inspections. All participants in the conversation stressed the significance of a fruitful discussion for the execution of GCP and GVP inspection protocols.
THE RIGHT TO HEALTH
31 October
Elena Popova (AIPM) facilitated a strategic conversation titled “The Future of the EAEU Markets” with representatives from regulatory bodies in Russia, Belarus, and Kazakhstan. Experts and regulators debated the benefits of establishing a unified pharmaceutical market within the EAEU, the intricacies of harmonized procedures, enhancing the accessibility of innovative products, the future of regulatory frameworks, the assessment of medical technologies, obstacles to operating in the common market, and strategies for overcoming them.
At the session “The significance of clinical guidelines in ensuring access to novel pharmaceutical treatments”, participants explored the necessity for the mandatory implementation of clinical guidelines (CG), with funding provided through the compulsory health insurance system. The significance of establishing uniform standards for evaluating the quality of healthcare, which are comprehensible to all stakeholders, was also highlighted. The event was facilitated by Alexander Martynenko (AIPM).
Furthermore, during the conference, the findings of a survey conducted among medical professionals regarding their digital literacy and their opinions on contemporary electronic healthcare services were shared. The survey was part of the nationwide study on the adoption of digital technologies in healthcare, which was supported by the All-Russian Medical Professionals Federation and the consulting firm “Right to Health”. Over 3,000 professionals participated in the survey.
NATIONAL HEALTHCARE
28–29 October
Larisa Matveeva and the members of the AIPM Board of Directors attended a series of meetings and a private gathering with representatives of the Russian Ministry of Health and the business community to discuss patent law and intellectual property protection. The focus of the discussion was on fostering innovation in the Russian pharmaceutical sector, promoting the development of domestic manufacturers capable of producing drugs from start to finish, and striking a balance between innovative companies and generic drug manufacturers. The participants shared a common objective — to expedite the market launch of effective and high-quality medications that meet the needs of patients, and to find a harmonious equilibrium between the interests of the state and business to establish a constructive partnership for the development of medicine safety strategies. The Russian and international approaches to the creation and regulation of medicine distribution can serve as a guide for future steps in this direction.
11 – 13 November
At the “Harmonization and Transition: Challenges and Solutions” session, Elena Popova, representing the AIPM, presented the Association's 2024 study on aligning with the legal framework of the Eurasian Economic Union (EAEU) to the regulators of the EAEU countries. Over 1,800 regulatory approvals have already been transitioned to the new regulations or are in the process of transition. Industry professionals and regulators discussed current procedures, methods for optimization, and adjustments to the regulatory framework. Anna Lakhtanova, Chair of the AIPM Regulatory Affairs Committee, highlighted the issues of mutual recognition and overcoming regulatory barriers during the session titled “You Can't Refuse to Admit — Where Should I Put the Comma?”. At another session focused on pharmaceutical inspections, participants reviewed legislation and current issues related to good practice inspections (GCP, GVP, GMP). Almira Galeeva, representing the AIPM, discussed the practical aspects of pharmaceutical inspections. All participants in the conversation stressed the significance of a fruitful discussion for the execution of GCP and GVP inspection protocols.
THE RIGHT TO HEALTH
31 October
Elena Popova (AIPM) facilitated a strategic conversation titled “The Future of the EAEU Markets” with representatives from regulatory bodies in Russia, Belarus, and Kazakhstan. Experts and regulators debated the benefits of establishing a unified pharmaceutical market within the EAEU, the intricacies of harmonized procedures, enhancing the accessibility of innovative products, the future of regulatory frameworks, the assessment of medical technologies, obstacles to operating in the common market, and strategies for overcoming them.
At the session “The significance of clinical guidelines in ensuring access to novel pharmaceutical treatments”, participants explored the necessity for the mandatory implementation of clinical guidelines (CG), with funding provided through the compulsory health insurance system. The significance of establishing uniform standards for evaluating the quality of healthcare, which are comprehensible to all stakeholders, was also highlighted. The event was facilitated by Alexander Martynenko (AIPM).
Furthermore, during the conference, the findings of a survey conducted among medical professionals regarding their digital literacy and their opinions on contemporary electronic healthcare services were shared. The survey was part of the nationwide study on the adoption of digital technologies in healthcare, which was supported by the All-Russian Medical Professionals Federation and the consulting firm “Right to Health”. Over 3,000 professionals participated in the survey.
NATIONAL HEALTHCARE
28–29 October
Larisa Matveeva and the members of the AIPM Board of Directors attended a series of meetings and a private gathering with representatives of the Russian Ministry of Health and the business community to discuss patent law and intellectual property protection. The focus of the discussion was on fostering innovation in the Russian pharmaceutical sector, promoting the development of domestic manufacturers capable of producing drugs from start to finish, and striking a balance between innovative companies and generic drug manufacturers. The participants shared a common objective — to expedite the market launch of effective and high-quality medications that meet the needs of patients, and to find a harmonious equilibrium between the interests of the state and business to establish a constructive partnership for the development of medicine safety strategies. The Russian and international approaches to the creation and regulation of medicine distribution can serve as a guide for future steps in this direction.