Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU

Dr. Gianni Dal Negro is an European Registered Toxicologist with over 30 years of experience in Research and Development applied to both the regulatory and non-regulatory areas in the pharmaceutical sector. In his career, he has represented the European Federation of Pharmaceutical Industries and Associations (EFPIA) in the ECVAM Scientific Advisory Committee (ESAC); he has been member of international committees and he has contributed to international initiatives relevant to the 3Rs (science, legislation, regulatory requirements). Before retiring, Dr. Dal Negro has been World-wide Director of 3Rs at GlaxoSmithKline Ltd, UK, Industry Chair of the European Partnership for Alternative Approaches to Animal Testing (EPAA), and member of the Royal College of Veterinary Surgeons in UK. He is past President of the Italian Association of Laboratory Animal Science (AISAL). Dr. Dal Negro has authored and co-authored several papers in peer-reviewed journals. He is also a member of the Editorial Board of the Journal Toxicology in Vitro (Elsevier). Dr. Silvia Sabbioni Pharm. D, PhD, is Professor in Laboratory Medicine at the University of Ferrara, Italy, where she teaches Microbiology. She is part of the Microarray Facility of the Emilia Romagna Region Life Sciences Technopole (LTTA) at the University of Ferrara, where she coordinates the microbiome studies in the NGS-based genome analysis service. Amongst her research activities, she is involved in the study of microRNAs in oncogenesis and, more recently, also in novel health surveillance approaches through microbiome analysis. She has authored and co-authored over 70 papers in peer-reviewed journals. Professor Sabbioni is also member of the Editorial Board of the Scientific Journal Cancers (MDPI, Basel, Switzerland). She is former member of the Emilia Romagna Region Ethical Committee and Chair of the Animal Welfare Body (AWB) of the University of Ferrara; currently, she is a AWB member at the same Institution and member of the Board of the Italian Association of Laboratory Animal Science (AISAL).

• 1. Ethics and law on human-animal relationship2. Communication and transparency in research involving animals3. Anatomy, physiological features, genetics and genetic alterations, breeding and strain differences relevant to the choice of the model-Impact of 3Rs 4. Animal welfare5. Methods of handling and procedures6. Animal health management and hygiene  7. Recognition of pain, distress, and suffering8. Harm to research animals, severity categories, and humane endpoints9. Anaesthesia, analgesia, and killing  10. Replacement  11. Design of procedures and projects