Bioanalysis Zone

EBF addresses… the future of the regulatory framework in bioanalysis


In this first video, the EBF panel addresses the regulatory framework within the bioanalytical community. Over the last 2 decades the number of regulations and guidelines has increased, greatly impacting the industry. The Panel discuss how the regulatory framework needs to evolve to ensure efficient scientific advancement whilst maintaining data integrity.

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Discussion highlights:

  • Instances where the complexity and diversity of regulations can cause conflict with science and innovation.
  • The benefits of having the ICH M10 Guideline to harmonize bioanalytical regulations and put regulations in context.
  • The importance of keeping science at the fore-front of any regulatory framework.
  • Keeping guidelines flexible and adaptable to keep up with the rapid rate of change within the industry and emergence of new technologies.
  • The role EBF has to bring the community together in order to promote global harmonization within the regulatory framework and create a global consensus.

Click to view the next video: EBF addresses… the future challenges and opportunities in biomarkers

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