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Session 3: Labeling Markets
Session Chair(s)
Deborah Bebbington
Head Global Labeling
Bayer Plc, United Kingdom
Theresa Brunone, MLS, MS
Head-Labelling Compliance and Implementation, Global Labeling
GlaxoSmithKline, United States
The details of labelling regulations vary greatly between markets. In some regions, multi-market guidelines have been developed to aid markets in creation and management of labelling. This session will illustrate examples of changes in regulatory strategy in areas beyond US, EU and Japan including the evolution of drug prescribing information regulations in Latin America and the Caribbean, and in Australia.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand the regulations supporting drug prescribing information in Latin America and the Caribbean
- Identify the changes in UK MHRA regulations as a result of Brexit – both those that are new and still in transition
Speaker(s)
Regulation of Drug Prescribing Information in Latin America and the Caribbean
Urimara Argotti-Rodriguez, MBA
Productos Roche S.A. DE C.V., Mexico
Regional Regulatory Policy LATAM Region, Global International Regulatory Policy
Australian Labelling Requirements and PV Audit Considerations
Jalpa Patel, PhD
Vertex Pharmaceuticals (Europe) Ltd, United Kingdom
Associate Director (ROW Labeling Lead)
Regulation of Drug Prescribing Information in Latin America and the Caribbean
Mariana Ramírez-Telles, PharmD
Roche Central America and the Caribbean, Costa Rica
Drug Regulatory Affairs Specialist
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