DIA Latin America Regulatory Conference

Virtual

February 22 - February 23, 2021

Virtual |

Join global regulators, industry, and academia to engage in a series of strategic discussions on current regulatory landscape, globalization, and harmonization initiatives in Latin America.

DIA brings you a symposium with interactive dynamics, where you will be engaged in discussions with key stakeholders influencing the advancement and implementation of regulatory convergence initiatives in Latin America.

Join us to discuss multi-regional cooperation, global harmonization, and best practices related to Latin America’s regulatory landscape. Sessions will highlight regulatory approaches and good practices to ensure reliance in Latin American and strategic initiatives to improve collaboration and cooperation.

Parexel Presentation

Session 5: Regulatory Pathways for IO drugs and How to Select the Right Endpoint(s)
Feb 23, 2021 11:30 AM – Feb 23, 2021 12:45 PM


From a medical and clinical point of view, it is important to point out that, when a disease is found in different stages, clinical studies to determine the safety and efficacy of the treatment are designed accordingly and regarding the disease to be treated /stage in which it is found. The intend of this session will be to discuss primary endpoints criteria of the clinical studies of IO drugs. In this session, we could bring with SME´s some of the most used valuation criteria. Guidance documents from the European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA) include endpoints that demonstrate clinical benefit and therefore can be used as primary endpoints in clinical trials seeking regulatory approval.
Learning Objective :

Surrogate Endpoints that FDA Accepts to Support an Accelerated Approval of IO Drugs
Amy McKee, Vice President, Regulatory & Access
 

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