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Session 5: Latin America, Middle East, and Africa Labeling Updates
Session Chair(s)
Gerrit Nijveldt, MS, MSC
Global Labeling Consultant , Opus Regulatory, United States
This session will discuss the requirements for labeling submission and regulatory agency approval in the Latin America and Middle East/Africa regions. Labeling strategies, including the use of shared labeling processes within some of the Latin American and Middle East/Africa countries, and the use and need for approved reference labeling prior to submission to agencies in some of the countries will be explored.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe labeling regulations for the LATAM and Africa/Middle East regions
- Discuss labeling for Deferred Action countries
Speaker(s)
Olga Lucia Anzola
Head Center of Expertise Labeling LATAM, Sanofi, Colombia
Labeling in LATAM Region
Nathalie Cunha-Da-Silva
Management Associate, Regulatory Excellence & Countries Management, Africa , Sanofi, France
Labeling in Africa/Middle East Region