Caroline Pothet Head of advanced therapies and haemato-oncology at the European Medicines Agency, shared a post on LinkedIn:
“The 2026 workplan of the Committee for Advanced Therapies is available with plenty to look forward to from webinars on the new guidelines, a reflection paper on gene editing, an update on the QandA on gene therapies and much more
This is also an excellent opportunity to reflect on 2025 Key Achievements beyond product assessment and support to developers:
- Published the Guideline on quality, non-clinical, and clinical requirements for investigational ATMPs
- Started a review of EU ATMP Clinical Trial Analysis with a manuscript in development
- Genome Editing – scientific workshop held (Sept 2025)with concept drafting set for 2026
- Responsible AI in Medicines – CAT training delivered and AI experts onboarded
- Real-World Data (RWD) – contribution to CAR-T studies and patient perspective integration
- Scientific Consultation and Evidence Generation – CAT contributed to joint HTA–regulatory workshop series and publication
- Companion Diagnostics and Biomarkers – provided support to EMA/CHMP and guideline development
- International Harmonisation – active collaboration to the ICH CandG Therapy discussions group and WHO workshops.
- Proud of the CAT’s contribution and progress made in strengthening innovation and fostering a fast path to safe and effective advanced therapies.”
Other articles featuring Caroline Pothet on OncoDaily.