On September 24, Moscow hosted the 7th annual scientific and practical conference "Real Clinical Practice. Possible and Achievable," featuring international participation. Larisa Matveeva, Executive Director of the Association of International Pharmaceutical Manufacturers (AIPM), addressed the plenary session. She emphasized the crucial role of real-world evidence (RWE) for Russia's future.
International manufacturers acknowledge the crucial role of real-world evidence (RWE) in combating socially significant diseases and advancing national goals. AIPM is actively shaping RWE development in Russia across three key domains, as Larisa Matveeva elucidated:
With the AIPM working group's involvement, three guidelines on using real-world evidence for regulatory decisions have been developed and submitted to the EEC. To enhance expertise, an educational course has been held for employees of member companies. Additionally, a methodological guide for doctors conducting RWE studies is in the works.
International manufacturers acknowledge the crucial role of real-world evidence (RWE) in combating socially significant diseases and advancing national goals. AIPM is actively shaping RWE development in Russia across three key domains, as Larisa Matveeva elucidated:
- Regulatory: Collaborating in the adaptation of international documents for the Eurasian Economic Commission.
- Educational: Enhancing skills among manufacturers and healthcare professionals.
- Scientific: Conducting research, delivering presentations, and publishing industry insights.
With the AIPM working group's involvement, three guidelines on using real-world evidence for regulatory decisions have been developed and submitted to the EEC. To enhance expertise, an educational course has been held for employees of member companies. Additionally, a methodological guide for doctors conducting RWE studies is in the works.
«To ensure the production of high-quality, effective, and safe medicines that compete in both domestic and international markets, it is crucial to expand the regulatory use of real-world clinical practice data. This is not a matter of "to do or not to do" but rather how to execute it efficiently and consistently. The EAEU already has a legal foundation; now, operational standards need to be established. Regulatory tools must be developed to assess the quality of non-interventional studies of innovative drugs for registration in Russia and the EAEU. It is proposed to initiate this dialogue at the EEC platform and support the introduction of amendments to regulatory acts,» Larisa Matveeva noted.
Globally, RWE has evolved into a full‑fledged tool for regulatory assessment. The WHO acknowledges RWD/RWE as a valuable source of evidence, while the FDA and EMA rely on them as primary sources for regulatory decisions. Japan and China use RWE as supplementary evidence. In Russia, RWE holds significant potential. It can expand the regulatory application of DRCP, aiding in the effective implementation of state strategies. RWE also serves as a tool for monitoring federal and regional programs, calculating medical product needs, assessing morbidity and healthcare quality, conducting economic evaluations, and forecasting budget impacts. Early assessment using RWE can expedite the launch of promising medical innovations, while compliance with international regulatory standards can boost the export of Russian medicines.
The AIPM will continue to champion high-quality and standardized approaches to RWE use in Russia and the EAEU. The association plans to support regulators in transitioning to value-based healthcare, promote RWE for regulatory purposes, and establish international standards as the cornerstone of the regulatory framework.
The AIPM will continue to champion high-quality and standardized approaches to RWE use in Russia and the EAEU. The association plans to support regulators in transitioning to value-based healthcare, promote RWE for regulatory purposes, and establish international standards as the cornerstone of the regulatory framework.