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Session 6 Track C: Topics of Special Interest for Regulatory Writers
Session Chair(s)
Christine Dale, MBA, MS
Independent Contract Writer
XWrite, LLC, United States
We have three presentations on current “hot topics” for regulatory writers: REMS Assessment Reports, Health Technology Assessments, and Benefit-Risk Assessment of Medicines. These are rapidly emerging areas needing writing support and may be new to most regulatory writers.
Learning Objective : At the conclusion of this session, participants should be able to:
• Examine three assessment types in understanding their purpose and overall structure
• Discuss the emerging areas in need of writing support
Speaker(s)
Faculty
Christine Dale, MBA, MS
XWrite, LLC, United States
Independent Contract Writer
Faculty
Eleni Allen, PHARMD
Amgen Inc., United States
Senior Manager, REMS Program Management (RPM)
Faculty
Lawrence Liberti, PHD, RAC
The Kim Center/ USC DRQS, United States
Director, D.K. Kim International Center for Regulatory Science