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Harmonizing Your Regulatory Submissions for Pharmacovigilance & RMPs
Session Chair(s)
Helena Pontes Pedrosa, PHARMD, PHD
Associate Director, Global Case Processing, Pharmacovigilance
UBC, Switzerland
Global patient safety activities require consistency across data while adhering to different requirements across varying geographies. Join UBC as we walk through a case study demonstrating development, implementation, challenges, and takeaways for global regulatory harmonization from clinical trial through post-marketing.
Speaker(s)
Harmonizing Your Regulatory Submissions for Pharmacovigilance & RMPs
Philippe Botteron, MD
UBC, Switzerland
Senior Safety/Project Physician, Pharmacovigilance