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Regulatory

New guidances for gene therapy

Giuliana Miglierini -

Time to innovate the EU variation system

Giuliana Miglierini -

The principles to develop ePI

Giuliana Miglierini -

EMA’s view on Pharmacovigilance in 2030

Giuliana Miglierini -

Revised guidelines on the use of genetics and genetic testing in...

Giuliana Miglierini -

EMA’s view on method validation

Giuliana Miglierini -

A Staff Working Document on EMA’s fees published by the EU...

Giuliana Miglierini -

Latest advancements in the EU-US Mutual Recognition Agreement for Pharmaceuticals

Giuliana Miglierini -

Comments from stakeholders to EMA’s Regulatory Science Strategy 2025

Giuliana Miglierini -

EMA’s updates on the business continuity plan and preparation for the...

Giuliana Miglierini -
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