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1.
Animals (Basel) ; 12(20)2022 Oct 14.
Article in English | MEDLINE | ID: mdl-36290164

ABSTRACT

A significant debate is ongoing on the effectiveness of animal experimentation, due to the increasing reports of failure in the translation of results from preclinical animal experiments to human patients. Scientific, ethical, social and economic considerations linked to the use of animals raise concerns in a variety of societal contributors (regulators, policy makers, non-governmental organisations, industry, etc.). The aim of this study was to record researchers' voices about their vision on this science evolution, to reconstruct as truthful as possible an image of the reality of health and life science research, by using a key instrument in the hands of the researcher: the experimental models. Hence, we surveyed European-based health and life sciences researchers, to reconstruct and decipher the varying orientations and opinions of this community over these large transformations. In the interest of advancing the public debate and more accurately guide the policy of research, it is important that policy makers, society, scientists and all stakeholders (1) mature as comprehensive as possible an understanding of the researchers' perspectives on the selection and establishment of the experimental models, and (2) that researchers publicly share the research community opinions regarding the external factors influencing their professional work. Our results highlighted a general homogeneity of answers from the 117 respondents. However, some discrepancies on specific key issues and topics were registered in the subgroups. These recorded divergent views might prove useful to policy makers and regulators to calibrate their agenda and shape the future of the European health and life science research. Overall, the results of this pilot study highlight the need of a continuous, open and broad discussion between researchers and science policy stakeholders.

2.
Biologicals ; 78: 17-26, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35840492

ABSTRACT

This online workshop Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps was organized on October 14th, 2021, by the Animal Free Safety Assessment Collaboration (AFSA), the Humane Society International (HSI), the European Federation of Pharmaceutical Industries and Associations (EFPIA), in collaboration with the International Alliance of Biological Standardization (IABS). The workshop saw a participation of over a hundred representatives from international organizations, pharmaceutical industries and associations, and regulatory authorities of 28 countries. Participants reported on country- and region-specific regulatory requirements and, where present, on the perspectives on the waiving and elimination of the Abnormal Toxicity Test. With AFSA, HSI, EFPIA and IABS representatives as facilitators, the participants also discussed specific country/global actions to further secure the deletion of ATT from all regulatory requirements worldwide.


Subject(s)
Toxicity Tests , Vaccines , Drug Industry , Humans , Reference Standards , Vaccines/adverse effects
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