News Hub

by Laura Mendieta, PhD
Asphalion
Spain

Alejandro Barquero, MPharm, MSc
Almirall
Spain

• Real-world evidence framework to support EU regulatory decision-making: 2nd report on the experience gained with regulator-led studies from February 2023 to February 2024 - 01 August 2024
  https://www.ema.europa.eu/en/documents/report/real-world-evidence-framework-support-eu-regulatory-decision-making-2nd-report-experience-gained-regulator-led-studies-february-2023-february-2024_en.pdf
  
  
• ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate real-world evidence, with a focus on effectiveness of medicines – 02 August 2024
  https://www.ema.europa.eu/en/documents/scientific-guideline/ich-reflection-paper-pursuing-opportunities-harmonisation-using-real-world-data-generate-realworld-evidence-focus-effectiveness-medicines_en.pdf
  
  
• Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation application – 9 September 2024
  https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-establishing-efficacy-based-single-arm-trials-submitted-pivotal-evidence-marketing-authorisation-application_en.pdf

MHRA

• Clinical Trials Regulation (CTR) Collaborate Stakeholder meeting, supported by ACT EU – 11 September 2024
  https://www.ema.europa.eu/en/events/clinical-trials-regulation-ctr-collaborate-stakeholder-meeting-supported-act-eu
• EMA Account Management, what's new? – 20 September 2024
  https://www.ema.europa.eu/en/events/ema-account-management-whats-new 

• Sixth European Medicines Agency - EuropaBio bilateral meeting – 1 October 2024
  https://www.ema.europa.eu/en/events/sixth-european-medicines-agency-europabio-bilateral-meeting 
• Scientific Symposium on Advanced Therapy Medicinal Products ‘Contribution, evolution, revolution’ – 10 October 2024
  https://www.ema.europa.eu/en/documents/agenda/agenda-scientific-symposium-advanced-therapy-medicinal-products-contribution-evolution-revolution_en.pdf
• Clinical Trials Information System (CTIS): Information day – 17 October 2024
  https://www.ema.europa.eu/en/events/clinical-trials-information-system-ctis-information-day-0
• Small and medium-sized enterprises info day – 18 October 2024
  https://www.ema.europa.eu/en/events/small-medium-sized-enterprises-info-day
• New fee regulation: webinar for human industry stakeholders – 24 October 2024
  https://www.ema.europa.eu/en/events/new-fee-regulation-webinar-human-industry-stakeholders
• Translating innovation into access for ATMPs: 3rd EU-Innovation network multi-stakeholder meeting – 15 November 2024
  https://www.ema.europa.eu/en/events/translating-innovation-access-atmps-3rd-eu-innovation-network-multi-stakeholder-meeting