Blog

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

ISSCR publishes guidelines for stem cell science

The International Society for Stem Cell Research (ISSCR), an international organization that gathers scientists from the area of stem cells, is currently preparing a document, that will provide information on good practices in stem cell research and stem cells based experimental therapies. Draft of the document has been already posted on-line but now the organization it accepting comments from the scientific community before publishing the final version.

The draft version gives recommendations on the procedures of tissues donation for stem cell isolation, in particular it provides guidelines on the information which should be provided to the donor. For example the donor should be informed if the cells would be genetically manipulated or used commercially in allogenic transplants. The donor should be tested for infectious agents and genetic diseases.

The isolated cells must be expanded in a Good Manufacturing Practice (GMP) compliant laboratory, which enforces strict testing of the cells at all stages of manufacturing. Furthermore, animal-derived additives used in the production process should be replaced by human-derived supplements or by chemically-defined substances. If the process of cellular product preparation involves extensive cell manipulations in vitro, for example prolonged culture or genetic modification, the tumorigenic potential and genetic integrity of cells should be checked.

The document also rises specific issues on the acquisition of embryonic stem cell and induced pluripotent stem cell lines. The document will be published for the purpose of guidance only and will not provide compulsory regulations. However, the policymakers in particular countries might include some of the recommendations in the relevant legal acts.

Source: http://www.isscr.org/

Drug Device Combination – mała rewolucja ?

Przysłuchując się dzisiejszemu spotkaniu Multi-stakeholder webinar to support implementation of the Medical Devices Regulation …

Medical device file / Dokumentacja wyrobu medycznego – ISO 13485

Medical device file / Dokumentacja wyrobu medycznego wymieniona w punkcie 4.2.3 Normy PN-EN ISO 13485 czasem nazywana przez …

UDI a wyroby Drug Device Combination Products

System niepowtarzalnych kodów identyfikacyjnych wyrobów ( „systemem UDI”), opisany w załączniku VI część C …