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[V3-S2] [Educational Session] Understand the Rules and Process of the US and EU Labeling
Session Chair(s)
Rie Matsui, RPh
Senior Director, Regional Labeling Head for APAC, International Labeling
Pfizer R&D Japan G.K., Japan
Centralized labeling within global companies has been further facilitated by MRCT progress. It is necessary to revisit the rules of US and EU labeling to identify the difference between the US/EU and Japan in order to properly understand the global headquarters’ intention. Moreover, the ruling process such as US PRA or CBE, and EU labeling process such as CP or MRP will be discussed for greater understanding. This session is important for people who are actually involved in the division of labeling management, as well as for people in divisions related to the new drug development.
Speaker(s)
Regulatory Procedures for Changing the Content of Healthcare Professional Labeling and Associated Patient Labeling: USA
A. Leander Fontaine, MD
Pharmiceutics, LLC., United States
President
Rules and Processes of the EU Labelling
Francesco Pignatti, MD
European Medicines Agency, Netherlands
Scientific Adviser for Oncology