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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

Draft Guidance Documents on GLP for public comments

The Organisation for Economic Co-operation and Development (OECD) published draft GLP document on the management, characterisation and use of tested items. The document is designed to provide guidance on: the transportation, identity, receipt, handling, storage, archiving and disposal of all test items used on GLP studies. Test items include agrochemicals, industrial chemicals, pharmaceuticals and biological agents (vaccine, antibody, enzyme, etc.). The scope of the guidance also covers formulated test items and medical devices.

Deadline for comments – 22 June 2017

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” …