EMA Events

EMA Scientific Advisory Group on Advanced Therapies Meeting

August 22, 2025

3 min read

EU Regulatory Team

Key discussions on emerging trends and regulatory challenges in advanced therapy development.

EMA Scientific Advisory Group on Advanced Therapies Meeting

The European Medicines Agency's Scientific Advisory Group on Advanced Therapies (SAG-AT) will convene in Amsterdam on August 22, 2025, to address pressing scientific and regulatory challenges in ATMP development.

Meeting Agenda and Key Topics

The two-day meeting will feature discussions on cutting-edge scientific developments and their regulatory implications:

Next-generation CAR-T cell therapy developments
In vivo gene editing regulatory considerations
Tissue engineering product classification challenges
Combination product regulatory pathways
Pediatric ATMP development strategies

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Scientific Discussion Points

The meeting will address several complex scientific and regulatory questions:

Potency assay development for novel cell therapies
Biomarker qualification for gene therapy efficacy assessment
Long-term safety monitoring requirements
Quality control strategies for personalized medicines
Environmental risk assessment for gene therapies

Topics Covered

EMASAG-ATAdvanced TherapiesScientific Advisory

EMA Scientific Advice

Strategic guidance for EMA scientific advice procedures and Scientific Advisory Group interactions.

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About the Author

Our EU Regulatory Team consists of experienced regulatory professionals with deep expertise in pharmaceutical development and regulatory strategy.

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