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Scientific guidelines (human and veterinary)
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Last updated 4 days ago
Concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development
4 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
4 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
11 days 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
11 days ago
Draft guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees...
Draft guideline for the evaluation of efficacy of ectoparasiticides - general requirements
11 days ago
Draft guideline for the evaluation of efficacy of ectoparasiticides - general requirements
Draft guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) - Revision 1
12 days ago
Draft guideline on the requirements for combined vaccines and associations of immunological...
Reflection paper on investigation and assessment of cardiovascular safety of anticancer medicinal products
12 days ago
Reflection paper on investigation and assessment of cardiovascular safety of anticancer medicinal...
Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals
about 2 months ago
Concept Paper on the revision of Annex 3 of the guidelines on...
Guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2
about 2 months ago
Guideline on the clinical investigation of medicinal products in the treatment of...
ICH E22 Guideline on general considerations for patient preference studies - Step 2b
about 2 months ago
ICH E22 Guideline on general considerations for patient preference studies - Step...
Guideline on stability testing for applications for variations to a marketing authorisation - Revision 3
about 2 months ago
Guideline on stability testing for applications for variations to a marketing authorisation...
Questions and answers on post approval change management protocols (PACMP) - Revision 1
about 2 months ago
Questions and answers on post approval change management protocols (PACMP) - Revision...