Workshop on the development of new medicines to treat tuberculosis

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Date: Venerdì, 25 Novembre 2016, All day
Sede: European Medicines Agency, Amsterdam, the Netherlands

The workshop brings together experts and stakeholders from the academic, regulatory and industrial sectors to discuss key issues and new developments in the field of development of antimycobacterial medicines to treat tuberculosis. The presentations and discussions support the finalisation of the newly drafted addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to mycobacterium tuberculosis. The workshop will be broadcast live.

Documents

Agenda - Workshop on development of antimycobacterial medicinal products (to treat Mycobacterium tuberculosis)

Adopted Reference Number: EMA/427839/2016

English (EN) (81.02 KB - PDF)

Pubblicato per la prima volta: 15/11/2016 Ultimo aggiornamento: 23/11/2016

List of participants - Workshop on development of antimycobacterial medicinal products (to treat Mycobacterium tuberculosis)

Reference Number: EMA/632391/2016

English (EN) (80.78 KB - PDF)

Pubblicato per la prima volta: 16/03/2017 Ultimo aggiornamento: 16/03/2017

Presentation - Aims and objectives of the workshop on development of antimycobacterial medicinal products (to treat Mycobacterium tuberculosis) (Mair Powell)

English (EN) (162.48 KB - PDF)

Pubblicato per la prima volta: 16/03/2017 Ultimo aggiornamento: 16/03/2017

Presentation - Topic 1 - In vitro models and animal models (Debra Hanna)

English (EN) (2.76 MB - PDF)

Pubblicato per la prima volta: 16/03/2017 Ultimo aggiornamento: 16/03/2017

Presentation - Topic 1 - Selection of agents, doses and regimens for clinical study (David Barros)

English (EN) (1.46 MB - PDF)

Pubblicato per la prima volta: 16/03/2017 Ultimo aggiornamento: 16/03/2017

Presentation - Topic 2 - Efficacy endpoints in clinical trials (Lawrence Geiter)

English (EN) (270.17 KB - PDF)

Pubblicato per la prima volta: 16/03/2017 Ultimo aggiornamento: 16/03/2017

Presentation - Topic 2 - Endpoints that may correlate with cure (Gerry Davies)

English (EN) (16.97 MB - PDF)

Pubblicato per la prima volta: 16/03/2017 Ultimo aggiornamento: 16/03/2017

Presentation - Topic 2 - Industry developers perspective (Robert Wallis)

English (EN) (453.41 KB - PDF)

Pubblicato per la prima volta: 16/03/2017 Ultimo aggiornamento: 16/03/2017

Presentation - Topic 2 - Trial design considerations for evaluation of new treatment regimens, an academic perspective (Andrew Nunn)

English (EN) (368.39 KB - PDF)

Pubblicato per la prima volta: 16/03/2017 Ultimo aggiornamento: 16/03/2017

Presentation - Topic 3 - Clinical development strategies and trial designs for new TB treatment regimens, Bedaquiline case study (Myriam Theeuwes)

English (EN) (2.65 MB - PDF)

Pubblicato per la prima volta: 16/03/2017 Ultimo aggiornamento: 16/03/2017

Presentation - Topic 3 - Clinical development strategies and trial designs for new TB treatment regimens (Carl Mendel)

English (EN) (136.69 KB - PDF)

Pubblicato per la prima volta: 16/03/2017 Ultimo aggiornamento: 16/03/2017

Presentation - Topic 3 - Evaluation of new treatment regimens, a clinicians perspective (Andreas Diacon)

English (EN) (55.57 MB - PDF)

Pubblicato per la prima volta: 16/03/2017 Ultimo aggiornamento: 16/03/2017

Presentation - Topic 3 - WHO perspective (Christian Lienhardt)

English (EN) (1.83 MB - PDF)

Pubblicato per la prima volta: 16/03/2017 Ultimo aggiornamento: 16/03/2017