Signal Management Throughout Products Life-Cycle 2018

Signal Management Throughout Products Life-Cycle 2018 is a workshop dedicated to new EudraVigilance requirements.

Topics

• Finding a balance between efficiency and ensuring no safety signals go unnoticed
• Signal Detection Methods Qualitative vs. quantitative assessment of ICSRs;
• Regulatory and Industry Requirements and Standards
• Signal Prioritisation differences between small, medium and big pharma
• New EudraVigilance requirements
• Quality system requirements: ensuring compliance and identifying gaps