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Scientific guidelines (human and veterinary)
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Last updated 7 days ago
Draft guideline on quality aspects of mRNA vaccines for veterinary use
7 days ago
Draft guideline on quality aspects of mRNA vaccines for veterinary use
Concept paper for the revision of the guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management (EMA/522332/2021)
15 days ago
Concept paper for the revision of the guideline on veterinary good pharmacovigilance...
Concept paper on the need of a guideline on clinical investigation of medicinal products in the treatment of Myasthenia Gravis
15 days ago
Concept paper on the need of a guideline on clinical investigation of...
ICH M15 Guideline on general principles for model-informed drug development - Step 5
17 days ago
ICH M15 Guideline on general principles for model-informed drug development - Step...
Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation
19 days ago
Concept paper on the revision of the guidelines on Good Manufacturing Practice...
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk - with tracked changes
21 days ago
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant...
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final considerations on pregnant and breastfeeding women and their children exposed in utero or via breastmilk
21 days ago
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with...
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk
21 days ago
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations III: Pregnant...
Concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development
28 days ago
Concept paper for the development of a reflection paper on the use...
Concept paper on the revision of the guideline on clinical evaluation of diagnostic agents and its appendix 1 on imaging agents
28 days ago
Concept paper on the revision of the guideline on clinical evaluation of...
Concept paper on the development of a guideline for using owner assessment as efficacy parameter
about 1 month ago
Concept paper on the development of a guideline for using owner assessment...
Draft guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees - Revision 2
about 1 month ago
Draft guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees...