@misc{Jujeczka_Ludwik_EU_2021,
 author={Jujeczka, Ludwik},
 address={Kraków},
 howpublished={online},
 year={2021},
 school={Rada Dyscypliny Nauki o zdrowiu},
 language={pol},
 abstract={The PhD thesis evaluates the current EU and Polish regulatory environment applicable to bacteriophage products used for therapeutic applications in humans (as representatives of non-standard or innovative medicinal products). The thesis was focused on market approval options, expectations relevant to manufacturing conditions (including good manufacturing practice and control over the supply chain) as well as regulations relevant to conducting clinical trials. The thesis provides: i) results of evaluation of EU regulations and regulations of some EU and non-EU countries relating to bacteriophage preparations, ii) results of systematic review of proposals of revision of the EU regulations applicable to bacteriophage preparations published in the scientific literature as well as iii) results of a survey distributed to EU regulatory agencies and academic or industrial units engaged in development, manufacture or administration of bacteriophage preparations. An overall discussion is focused on options to improve the current regulations so that to increase the availability of bacteriophage products (and other non-standard or innovative medicinal products) for patients while ensuring an appropriate level of supervision.},
 title={EU and Polish regulatory environment applicable to bacteriophage products (as representatives of innovative or non-standard medicinal products) and options for improvement},
 type={Praca doktorska},
 keywords={bacteriophage, phage therapy, regulatory},
}