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Signal Management Throughout Products Life-Cycle

Are you ready for new EudraVigilance requirements?

Meet expert trainer

  • Shelley Gandhi
  • Strategic Advisor
  • NDA Group, United Kingdom
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KEY TOPICS

Signal Detection Methods Qualitative vs. quantitative assessment of ICSRs;

Finding a balance between efficiency and ensuring no safety signals go unnoticed

Signal Prioritisation differences between small, medium and big pharma

Regulatory and Industry Requirements and Standards

Quality system requirements: ensuring compliance and identifying gaps

New EudraVigilance requirements

Key takeaways:

Understand

√ New GVP IX and GVP VI and impact for signals

√ Qualitative vs. quantitative assessment of ICSRs

√ Challenges for signal detection including new E2B (R3) standard

Learn

√ About methods for signal detection

√ Statistical methods in the EudraVigilance data analysis system

√ About breakdown of signal detection processes and PRAC involvement

Gain

√ Kowledge about the use of eRMR and new EVDAS tools

√ Best practices in Triage methodologies

√ Maintaining an Audit Trail and being Inspection Ready

REGISTRATION

Delegate fee

from 2396 € Buy

CUSTOMIZE THIS TRAINING TO YOUR COMPANY NEEDS

Based on your requirements, we will build a practical training including content tailored to your specific needs, our cutting edge methodologies and relevant modules from our training portfolio.

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PARTNERS AND SPONSORS

This event is supported by the following companies.

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Staalmeesterslaan 410, 1057 PH, Amsterdam

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