At the IX Pan-Russian GMP Conference, held in Ufa from August 21 to 23, 2024, Stanislav Uiba, General Manager of Institute MECHNIKOV delivered a presentation focused on the specifics of registration and promotion of pharmaceutical products in Latin America and the Caribbean.
In his speech, Mr. Uiba detailed the current regulatory requirements and harmonization processes in this vast and diverse region, with total population of over 670 million people within 41 countries with diverse regulatory systems. He highlighted that despite unification efforts, the region still faces logistics challenges and differences in regulatory approaches.
Stanislav Uiba paid special attention to the CTD dossier importance, various document requirements and their translation, as well as the opportunities provided by international organizations such as the World Health Organization (WHO) and the Pan American Health Organization (PAHO). He emphasized the importance of WHO prequalification for expedited registration and the potential to participate in vaccine procurement tenders held by international foundations.
Uiba also discussed the achievements of the Institute MECHNIKOV, noting that to date the Institute has supplied over 26 million doses of vaccines, including flu vaccines and COVID-19 vaccine ConvacellÒ that currently undergoes the technology transfer process. He stressed that the Institute is actively developing its regulatory practices and successfully implementing plans to expand its presence in international markets.
The Pan-Russian GMP Conference is the largest annual event in the field of good manufacturing practices, bringing together pharmaceutical industry specialists, testing centers, and regulatory authorities to discuss current issues, share experiences, and optimize the processes for bringing products to market.
In his speech, Mr. Uiba detailed the current regulatory requirements and harmonization processes in this vast and diverse region, with total population of over 670 million people within 41 countries with diverse regulatory systems. He highlighted that despite unification efforts, the region still faces logistics challenges and differences in regulatory approaches.
Stanislav Uiba paid special attention to the CTD dossier importance, various document requirements and their translation, as well as the opportunities provided by international organizations such as the World Health Organization (WHO) and the Pan American Health Organization (PAHO). He emphasized the importance of WHO prequalification for expedited registration and the potential to participate in vaccine procurement tenders held by international foundations.
Uiba also discussed the achievements of the Institute MECHNIKOV, noting that to date the Institute has supplied over 26 million doses of vaccines, including flu vaccines and COVID-19 vaccine ConvacellÒ that currently undergoes the technology transfer process. He stressed that the Institute is actively developing its regulatory practices and successfully implementing plans to expand its presence in international markets.
The Pan-Russian GMP Conference is the largest annual event in the field of good manufacturing practices, bringing together pharmaceutical industry specialists, testing centers, and regulatory authorities to discuss current issues, share experiences, and optimize the processes for bringing products to market.