Safety labeling has become recognized as an integral part of a company’s global pharmacovigilance system. As important as for risk-related information is worldwide consistency for usage-related information that serves to ensure a positive benefit/risk balance. This highly interactive conference convenes regulatory/labeling and pharmacovigilance professionals from large and small companies to discuss and exchange experiences in meeting increasingly strict regulatory expectations. Key topics will include the design of the interface between the PV and global labeling process; creation of core safety information and supporting rationales that meet regulatory expectations; specific process features and policies; tracking targets, approaches, granularity and tools; and labeling self-audits.
Benefits of Attendance
Now available! Discover key topics and planned exercises when you download the current program agenda.
Elizabeth Moyle, Biomarin Pharmaceutical, Inc.
Executive Director, Regulatory Global Labeling
Paul Neihouse, PharmD Celgene
Global Labelling, Corporate Operations for Regulatory Affairs
Date: October 5 – 6, 2017
Location: DoubleTree by Hilton – Crystal City, Arlington, VA
Course Rate: $1795
This course has concluded. Please check the website soon for Spring 2018 course information.
DoubleTree by Hilton
Washington, DC – Crystal City
300 Army Navy Drive
Arlington, VA 22202