Drug Safety Reporting, Regulations, and Risk: What is Required Today and Where Will We Be Tomorrow?


28th May, 2008

Time: 11:00 am (EST) 16:00 (BST)

Presentations by:

Leanne Larson, MHA
Vice President, Registry Consulting, ICON Lifecycle Sciences Group

Donelle Bussom, RN
MSN Senior Director, Drug Safety

Topics to be covered include:

  • Current status of FDA and EMEA perspectives on risk management and safety reporting
  • Insights into future global regluatory requirements and their impact on product review
  • Various approaches to meeting requirements, including trials and registries

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