Day Two – 17 June 2025Tuesday, 17 June 2025 - CEST Time Zone

• The beginnings of the BE

• Intent of a BE

• Definitions and foundations

• Standard intent vs regulator interpretation

• As IVDs and Pharmaceuticals become ever more intertwined, how are both industries finding collaboration?

• Commonalities in regulatory processes, experiences and pain points

• How can both sides support each other?

• How does increased collaboration impact diagnostic market availability?

Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• Utilizing Design inputs

• How to properly define intended use and device categorization

• Literature search

• How to reference competitive devices

• Clinical evaluation data integration

• Group divisions and BEP creation exercise

• E&L test requirements and set up

• Correct Dose Base Threshold (DBT) for device

• Calculation of Analytical Evaluation Threshold (AET)

• Method Uncertainty Factor (UF), sensitivity, solvent selection

• Applying to intended use and materials

• Traditional endpoint tests and critical factors

  • In-vitro vs In-vivo

  • Extraction time, temp, and ratios.

  • Determining gaps from E&L, literature, etc to determine appropriate endpoint test

• Group division and BEP completion

• Current status of regulating companion diagnostics under both IVDR and EMA

  • Are there differences in regulating oncology CDx vs others?

  • Does every assay need to be CE marked?

• Experiences with regulating these types of diagnostic

  • Comparison of competent authority, notified body, and industry experiences

  • Common challenges and methods to overcome

• E&L test reports and applying AET for compound analysis

• Acceptance criteria for traditional endpoint tests

• Common deviations

• What to do if you fail

• Addition of all test data and results determination

• Gap assessment to data, deviations, historical testing

• Developing a final conclusion

• Group division and BER completion

Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• tests and LDTs

  • How does regulation differ between the EU and US?

• What was changed for all stakeholders?

  • Areas of particular consideration for manufacturers

  • Longer term impact of more stringent regulations

• Future outlook on wider patient health and safety

• Evaluating compounds

• NOAEL/LOAEL

• Cramer categorization

• Unknown determination

• MOS calculation per ISO 10993-17

• Group division and Tox assessment

• With the US shifting to align with QMS 13485, what does this mean for manufacturers operating in the US market?

  • Is there much difference between the existing QMSR and 13485?

  • How much does a manufacturer need to change?

  • What impact will there be, if any, on the European market?

• What does this harmonisation mean for the future?

  • Can further harmonisation between the EU and US be expected on other regulations?

Have burning questions left over from the last 2 days? Take the opportunity to connect with our speakers and raise those final questions in our ‘Ask the Experts’ panel!