Scientific Guidelines
Scientific guidelines (human and veterinary)
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Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence
Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence -
Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure
Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure -
Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products
Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products -
Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling
Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling -
Concept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations
Concept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations