Avexima participates in the «RegLek 2024» Conference

Avexima took part in the landmark scientific and practical conference «RegLek 2024» for the pharmaceutical industry, organized by the Scientific Center for Expert Evaluation of Medicinal Products of the Russian Ministry of Health.

This unique event brings together leading experts, heads of regulatory agencies from the EAEU member states, and representatives of the pharmaceutical industry to exchange views and engage in constructive dialogue on current issues of regulatory review and drug registration, clinical trials, and pharmacovigilance.

Among the conference participants were representatives of regulatory authorities from EAEU countries, Uzbekistan, Brazil, Cuba, Vietnam, and Indonesia.

In recent years, a new vision of regulatory requirements for conducting studies, preparing, and submitting registration dossiers has been actively developing within the EAEU regulatory framework.

Participation in the conference provides an excellent opportunity to learn about and discuss the latest updates and changes in the regulatory framework, and their practical application in the field.

Within the session «Approaches to Quality Assessment of Various Dosage Forms Considering the Requirements of National and Union Regulatory Acts in Drug Registration», Natalia Stepushina, Director of Registration and Clinical Trials at Avexima JSC, delivered a presentation on «Challenging Issues in Preparing the Quality Module of a Drug Registration Dossier». In her presentation, she shared the company's experience in addressing challenges that arise when compiling registration dossiers in accordance with EAEU regulations.