News related to Regenerative Medicine, Tissue Engineering, Medical devices, Pharmaceutical industry with focus on achievements and the legal, ethical, and regulatory aspects of the field

New regulations in in vitro fertilization procedure in Poland

The new act sets strict regulations in the in vitro fertilization procedure. Destruction of embryos capable of normal development will be prohibited. Preimplantation genetic testing for selection of phenotypic traits will be also forbidden. Genetic screening will be only possible if the child would be likely to suffer from a severe genetic disease.

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Statement of the Minister of Health

Minister of Health recalls that all activities within the scope of the “Polish Act on the collection, storage and transplantation of cells, tissues and organs” (Journal of Laws No. 169, item 1411, as amended) on the basis of only the consent of the Bioethics Committee, without the permission of the Minister of Health is violation of regulations of the Act. The law penalizes all activities conducted without the required permit.

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Public Stem Cell Bank

Public Stem Cell Bank at Regional Science-Technology Centre in Podzamcze was launched on November 4th. The Bank was established as a result of the project within the framework of the Regional Operational Programme 2007-2013 for Świętokrzyskie region. Public Stem Cell Bank in Podzamcze joined the elite group of five other public banks of umbilical cord blood in Poland. BMCT held patronage over the press conference promoting the project.

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Czy należy ubezpieczyć nasze wyroby medyczne?

Nie jest to nowością, że sponsor i badacz w badaniu klinicznym są zobowiązani do posiadania ubezpieczenia od odpowiedzialności …

EUDAMED a informacje publiczne

Niedawno został opublikowany dokument który pokazuje w jaki sposób będzie realizowana polityka przejrzystości informacji …

MedTech Europe help for Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union

The “Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union” …