The Implementation of Good Regulatory Practices – Regulatory Impact and Effectiveness 

The Inter-American Coalition for Regulatory Convergence, Medical Technology Sector, under the MDRC Project and in collaboration with the US FDA, organized a session on “The Implementation of Good Regulatory Practices – Regulatory Impact and Effectiveness” with the purpose to provide in-depth discussion and recommendations for conducting Regulatory Impact Analysis and effectiveness of rules through a case study.

Agenda

Recording

Presentations

MDRC Update on GRP Related Activities in Latin America Region – Sandra Ligia González, MDRC

FIFARMA Update on GRP Related Activities in Latin America Region – Camilla Gomes, FIFARMA

Using Good Regulatory Practices to Inform Regulation Development and Regulatory Impact Analysis – Maria Kuecken, Senior Economist, Office of Economics and Analysis, FDA

How FDA Communicates Regulatory Information with Stakeholders – Kristan Callahan, Senior Public Health Advisor, Office of Trade and Global Partnerships, FDA