Challenges in Biosimilars Pharmacovigilance

This session of the Biosimilars 2016 will look into the future and FDA initiatives that have already been announced to include enhanced tracking and follow-up of post marketing surveillance issues, planned improvements in AERS, and pilots of new post market drug-monitoring strategies and ADR related issues.Biosimilar guidelines for pharmacovigilance practice and pharmacoepidemiology are the points that shall be laid emphasis in this session.

U.S. average annual spending growth from 2002 to 2007 was 16% for biologics, compared with 3.7% for drugs. In same proportion pharmacovigilance for biosimilars has been comparitively more than other pharmaceutical products.

  • Current problems in biosimilar pharmacovigilance
  • Adverse drug reactions with biologics and biosimilar products
  • Detection and evaluation of drug safety signals
  • Role of pharma industries in the improvement of pharmacovigilance system
  • Good pharmacovigilance practice and pharmacoepidemiology

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