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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 Inc., 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)
Labeling in LATAM Region
Olga Lucia Anzola
Sanofi, Colombia
Head Center of Expertise Labeling LATAM
Labeling in Africa/Middle East Region
Nathalie Cunha-Da-Silva
Sanofi, France
Management Associate, Regulatory Excellence & Countries Management, Africa
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