Day Three – 18 June 2025Wednesday, 18 June 2025 - CEST Time Zone

• What does the latest revision to ISO 10993-1 really mean for you?

• What are the biggest changes between versions?

• What do manufacturers and testing facilities need to do differently?

• Case study example of adhering to –1 before and after revision

• One of the key revisions for –1 centres around genotoxicity, but what does this mean?

• Which groups is this endpoint applicable to now?

• Why has this change materialised?

• What does this increased evaluation mean for wider public health?

• Best practices for applying genotoxicity to those who have not previously

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• With –17 having been in place for 1 year, what are industry’s first experiences of adhering to the standard?

• Are there differences in EU and FDA acceptance?

• Can we expect further alignment?

• Which parts are causing the most confusion?

• Possible solutions to ease working under -17

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• What are these updates?

• Are there any impacts for manufacturers?

• Do biological evaluations and modalities need to be revised?

• Which alternatives are available, and should we consider using them?

• As the debate rumbles on, where are we with global acceptance of in vitro vs in vivo testing?
  • Has the US moved more towards acceptance?
• Industry implications
  • Can industry streamline testing methods to be applicable for both regions?
  • Which areas commonly cause issues with submissions?
    • Practices to overcome