Eliza Slawther

4 days ago | insights.citeline.com | Eliza Slawther

Industry Highlights Issues With EU HTA Regulation’s PICO Framework For VaccinesVaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says. The PICO framework used for EU-level HTA assessments might be unsuitable for vaccines (Shutterstock)

1 week ago | insights.citeline.com | Eliza Slawther

EU HTA Regulation: Don’t Forget About Vaccines, Industry WarnsEurope’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years. The vaccines industry warns that the EU HTA Regulation could pose challenges for immunizations (Shutterstock)

1 week ago | insights.citeline.com | Eliza Slawther

Industry Keen On ‘Stepwise’ PIPs, But Future Hinges On EU Pharma Legislation ReformIndustry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says. Industry is eager to implement a new stepwise approach to pediatric investigation plans in the EU (Shutterstock)

1 week ago | insights.citeline.com | Eliza Slawther

EU Regulators Push For Better Support For Sponsors On Using Animal Study AlternativesThe European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies. Sponsors need clarity on when they can use alternatives to animal testing in drug development (Shutterstock)

2 weeks ago | insights.citeline.com | Eliza Slawther

Industry Urged To Respond To EU Expectations On Using Animal Testing AlternativesThe chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies. EU regulators are updating scientific guidelines around alternatives to animal testing (Shutterstock)