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This publication is protected and can be accessed only from certain IPs.

Title: EU and Polish regulatory environment applicable to bacteriophage products (as representatives of innovative or non-standard medicinal products) and options for improvement

Author:

Jujeczka, Ludwik

Date:

2021

Type:

Praca doktorska

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.

Place of publishing:

Kraków

Level of degree:

2 - studia doktoranckie

Degree discipline:

choroby zakaźne ; zdrowie publiczne

Degree grantor:

Rada Dyscypliny Nauki o zdrowiu

Promoter:

Pilc, Andrzej ; Bochenek, Tomasz

Date issued:

2021

Identifier:

oai:dl.cm-uj.krakow.pl:4592

Call number:

ZB-134476

Language:

pol

Access rights:

tylko w bibliotece

Subject and keywords:

bacteriophage phage therapy regulatory

Object collections:

Last modified:

Apr 8, 2024

In our library since:

Mar 31, 2022

Number of object content hits:

1

Number of object content views in PDF format

0

All available object's versions:

http://dl.cm-uj.krakow.pl:8080/publication/4593

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Edition name Date
ZB-134476 Apr 8, 2024

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