The patients in all jurisdictions are expecting timely access to high-quality medicines and vaccines when they need them. To facilitate this public health goal, strengthening of regulatory systems in all regions is currently ongoing under the leadership of the WHO. A strong regulatory system is an essential piece for a well-functioning health ecosystem. Collaboration and sharing of information among regulatory agencies are new trends in regulatory science.

The COVID pandemic has catalyzed increasing cooperation and collaboration amongst regulators and more frequent communication with applicants. Regulators piloted new ways of working to increase speed of regulatory actions, achieve global alignment and focus available resources on important public health matters. The post-pandemic years have witnessed an increase in collaboration and in the implementation and use of Reliance to support regulatory system innovation and strengthening.

Harmonization of requirements towards global standards, convergence of regulatory processes and frameworks that allow sharing of confidential information are foundational to support agency collaboration across countries and regions. In addition, the speed of technology innovation is accelerating, and regulatory workload is increasing. To cope with this demand, regulators are implementing reliance pathways for different regulatory activities, such as initial applications, inspections, lab testing, post-approval changes and pharmacovigilance. Regulatory reliance has become a 21st century regulatory science tool for more efficient decision making and smarter use of regulatory resources.

Transparency and trust are necessary to establish more collaboration between regulators and contribute to global convergence. Collaboration with Industry users is key to ensure efficient, practical implementation across international markets.

This Reliance Pre-Conference Workshop will bring together regulators from the different countries participating in the DIA Latin America Annual Meeting and industry stakeholders to discuss the practical aspects of collaboration and convergence of country-specific requirements towards global standards.

We aim to provide perspectives from regulators and Industry to achieve a common understanding and co-create solutions for current bottlenecks.

Join us at DIA’s Reliance Workshop to connect with regulators and industry leaders to co-create solutions for global regulatory alignment and strengthen collaboration.