The BIC Review Tool is designed to improve communication, it allows an “inventors interview”-type of approach, in addition to being a checklist for Technology Transfer Offices and Researchers. It is designed to improve communication between the stakeholders involved in the commercialization process and to facilitate collaboration. The tool is therefore in a completely different format than the Biomarker Commercialization (BIC) Guide. All introductions and explanations are missing by intention since they can already be found in the BIC Guide, Best & Pitfall Practices handbook or the Regulatory Guide.View this resource Bookmark this resource
This guidance is for qualification process addresses innovative drug development methods and tools. It will focus on the use of novel methodologies developed by consortia, networks, public/private partnerships, learned societies and pharmaceutical industry for a specific intended use in pharmaceuticals R&D.View this resource Bookmark this resource
This is a note for guidance on the preclinical evaluation of new vaccine products including combined vaccines, vaccines are those containing antigens not yet described in European Pharmacopoeia monographs or in WHO requirements and vaccines containing live organisms. It indicated the suitable animal models and ethics issues for vaccine preclinical testing.View this resource Bookmark this resource
EMAGuidelineVaccineToxicityAnimal ModelsNon-Clinical Testing
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on Adjuvants in Vaccines for Human Use. 2005 (EMEA/CHMP/VEG/134716/2004).
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on the Need for Non-Clinical Testing in Juvenile Animals of Pharmaceuticals for Paediatric Indications. 2008 (EMEA/CHMP/SWP/169215/2005).
Published by European Medicines Agency (EMA)EMAGuidelineAnimal ModelsNon-Clinical TestingJuvanile AnimalsPaediatric Indications
This document provides guidance on the need for, role and timing of studies in juvenile animals in the non-clinical safety evaluation of medicinal products for paediatric use. It is applicable to initial medicinal products applications and also to authorised medicinal products being further developed to include paediatric indications. It outlines potential safety concerns that cannot be adequately assessed in the adult population, in standard non-clinical studies, or in clinical trials.View this resource Bookmark this resource