Course “CMC writing and submission strategies”
Lunedì 15 Luglio 2013 12:25
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This course will provide in-depth instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and post approval drug applications in the US, Europe and Japan. Additional considerations and integrative approaches for submissions in emerging markets will be discussed.
Course Topics include:
  • Drug Substance and Drug Product Data in Clinical Trial and Marketing Applications
  • Regulatory CMC Strategies for Global Filings
  • Regulatory Compliance and Change Management Considerations
  • Case Studies

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