Safety Observer - Regulatory Intelligence for Pharmacovigilance

• 
  November 2018

  Latest ReleaseSafety Observer 150

  • New EU GVP Chapter on paediatrics

  • Revised PV Guidance for MRPs

  • New ISoP GVP Manual for LATAM

  • New FDA Guidance documents

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• 
  October 2018

  Safety Observer 149

  • MHRA consults on "no-deal Brexit" proposals

  • ICH updates ICH E2B(R3) Q&As

  • New FDA Draft Guidance

  • GPvP in Brazil

  • Quinolones and fluoroquinolones

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• 
  September 2018

  Safety observer 148

  • Brexit preparedness

  • EudraVigilance and MAH obligations

  • EU Clinical Trial Safety

  • FDA Draft Guidance

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