Pharmacovigilance & Safety of Biosimilars

Biosimilars are interlinked with FDA activities that have as of now been declared to incorporate upgraded following and follow-up of post market issues, arranged changes in AERS, and pilots of new post advertise medicate observing systems. Current difficulties in pharmacovigilance, adverse medication responses with pharmaceutical items, Biosimilar rules for Pharmacovigilance practice and pharmacoepidemiology are the focuses that should be laid accentuation in this session.

  • Improve Pharmacovigilance through Patient and Provider Education
  • Regulatory updates and key drivers for registration approvals in US, EU and China
  • Regulatory requirement for biosimilar IND filing in the US

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