Aurélie Mahalatchimy
Biographic Data
| ID | 6308034 |
|---|---|
| NAME | Aurélie Mahalatchimy |
| GIVEN NAMES | Aurélie |
| FAMILY NAME | Mahalatchimy |
| SIGNATURE | MAHALATCHIMY A |
| AFFILIATIONS | Laboratoire Pacte |
| ORCID | 0000-0002-4365-2143 |
| VERIFIED | Yes |
| TOTAL WORKS | 5 |
| TOTAL CITATIONS | 2 |
| WORKS AS AUTHOR | 5 |
| WORKS AS EDITOR | 0 |
| FIRST PUBLICATION YEAR | 2012 |
| LATEST PUBLICATION YEAR | 2025 |
| H-INDEX | 1 |
Participation in SoHO and ATMP public consultations
In the European Union (EU), the recent adoption of the Substances of Human Origin (SoHO) Regulation in June 2024 brings into force new harmonised rules for human cells, tissues and blood. This legislation interacts with the pre-existing Advanced Therapy Medicinal Products (ATMP) Regulation. This paper looks at the recent EU public consultations on the proposed SoHO Regulation and compares them with the prior consultations on the ATMP Regulation g…
Deciphering the Fragmentation of the Human Genome Editing Regulatory Landscape
Genome editing techniques have generated a growing interest following the discovery of the so-called CRISPR-Cas technique. It has raised a global uproar as regards its use in humans, especially after the 2018 announcement of a Chinese scientist who had used CRISPR to edit the genes of twin embryos. Indeed, one of the greatest concerns, although not the only one, has been the use of genome editing technologies to modify the human germline. In such…
The politics of valuation and payment for regenerative medicine products in the UK
The field of regenerative medicine (RM) faces many challenges, including funding. Framing the analysis in terms of institutional politics, valuation studies and “technologies of knowledge”, the paper highlights growing debates about payment for RM in the UK, setting this alongside escalating policy debates about “value”. We draw on interviews and publicly available material to identify the interacting and conflicting positions of institutional st…
Producing ‘Human Elements Based Medical Technologies’ in Biotech Companies
This article is based on the findings of an EU-funded qualitative research project, entitled ‘From GMP to GBP: Fostering good bioethics practices [GBP] among the European biotechnology industry’, which seeks to improve the understanding of bioethical issues through the observation of the daily practices in European biotechnology companies and proposes a methodology approaching ethical issues. The comparative study was carried out in biotech compa…
The Legal Landscape for Advanced Therapies
In 2007, the European Union adopted a lex specialis , Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (ATMPs), a new legal category of medical product in regenerative medicine. The regulation applies to ATMPs prepared industrially or manufactured by a method involving an industrial process. It also provides a hospital exemption, which means that medicinal products not regulated by EU law do not benefit from a harmonized regim…
The Legal Landscape for Advanced Therapies
In 2007, the European Union adopted a lex specialis , Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (ATMPs), a new legal category of medical product in regenerative medicine. The regulation applies to ATMPs prepared industrially or manufactured by a method involving an industrial process. It also provides a hospital exemption, which means that medicinal products not regulated by EU law do not benefit from a harmonized regim…
The Legal Landscape for Advanced Therapies
In 2007, the European Union adopted a lex specialis , Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (ATMPs), a new legal category of medical product in regenerative medicine. The regulation applies to ATMPs prepared industrially or manufactured by a method involving an industrial process. It also provides a hospital exemption, which means that medicinal products not regulated by EU law do not benefit from a harmonized regim…
Producing ‘Human Elements Based Medical Technologies’ in Biotech Companies
This article is based on the findings of an EU-funded qualitative research project, entitled ‘From GMP to GBP: Fostering good bioethics practices [GBP] among the European biotechnology industry’, which seeks to improve the understanding of bioethical issues through the observation of the daily practices in European biotechnology companies and proposes a methodology approaching ethical issues. The comparative study was carried out in biotech compa…
The politics of valuation and payment for regenerative medicine products in the UK
The field of regenerative medicine (RM) faces many challenges, including funding. Framing the analysis in terms of institutional politics, valuation studies and “technologies of knowledge”, the paper highlights growing debates about payment for RM in the UK, setting this alongside escalating policy debates about “value”. We draw on interviews and publicly available material to identify the interacting and conflicting positions of institutional st…
Deciphering the Fragmentation of the Human Genome Editing Regulatory Landscape
Genome editing techniques have generated a growing interest following the discovery of the so-called CRISPR-Cas technique. It has raised a global uproar as regards its use in humans, especially after the 2018 announcement of a Chinese scientist who had used CRISPR to edit the genes of twin embryos. Indeed, one of the greatest concerns, although not the only one, has been the use of genome editing technologies to modify the human germline. In such…
Participation in SoHO and ATMP public consultations
In the European Union (EU), the recent adoption of the Substances of Human Origin (SoHO) Regulation in June 2024 brings into force new harmonised rules for human cells, tissues and blood. This legislation interacts with the pre-existing Advanced Therapy Medicinal Products (ATMP) Regulation. This paper looks at the recent EU public consultations on the proposed SoHO Regulation and compares them with the prior consultations on the ATMP Regulation g…
Business (5 works) · Political science (5 works) · Biomedical Ethics and Regulation (4 works) · Law (4 works) · Law (3 works) · Biology (2 works) · Engineering (2 works) · European union (2 works) · Framing (construction (2 works) · Geography (2 works)