Pharmacovigilance Challenges and Safety

 

 

<p justify;"="" style="text-align: justify;">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 comparatively more than other pharmaceutical products. 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.


  • Current problems in Pharmacovigilance
  • Adverse drug reactions with Pharmaceutical products
  • Detection and evaluation of drug safety signals
  • 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
  • Role of Pharma industries in the improvement of Pharmacovigilance system

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