Global Labeling Conference

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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