Workshop on the development of new medicines to treat tuberculosis
Date:
25/11/2016
Location:
European Medicines Agency, London, UK
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.
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Agenda - Workshop on development of antimycobacterial medicinal products (to treat Mycobacterium tuberculosis) (PDF/81.02 KB)
Adopted
First published: 15/11/2016
Last updated: 23/11/2016
EMA/427839/2016 -
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List of participants - Workshop on development of antimycobacterial medicinal products (to treat Mycobacterium tuberculosis) (PDF/80.78 KB)
First published: 16/03/2017
Last updated: 16/03/2017
EMA/632391/2016 -
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Presentation - Aims and objectives of the workshop on development of antimycobacterial medicinal products (to treat Mycobacterium tuberculosis) (Mair Powell) (PDF/162.48 KB)
First published: 16/03/2017
Last updated: 16/03/2017 -
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Presentation - Topic 1 - In vitro models and animal models (Debra Hanna) (PDF/2.76 MB)
First published: 16/03/2017
Last updated: 16/03/2017 -
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Presentation - Topic 1 - Selection of agents, doses and regimens for clinical study (David Barros) (PDF/1.46 MB)
First published: 16/03/2017
Last updated: 16/03/2017 -
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Presentation - Topic 2 - Efficacy endpoints in clinical trials (Lawrence Geiter) (PDF/270.17 KB)
First published: 16/03/2017
Last updated: 16/03/2017 -
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Presentation - Topic 2 - Endpoints that may correlate with cure (Gerry Davies) (PDF/16.97 MB)
First published: 16/03/2017
Last updated: 16/03/2017 -
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Presentation - Topic 2 - Industry developers perspective (Robert Wallis) (PDF/453.41 KB)
First published: 16/03/2017
Last updated: 16/03/2017 -
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Presentation - Topic 2 - Trial design considerations for evaluation of new treatment regimens, an academic perspective (Andrew Nunn) (PDF/368.39 KB)
First published: 16/03/2017
Last updated: 16/03/2017 -
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Presentation - Topic 3 - Clinical development strategies and trial designs for new TB treatment regimens, Bedaquiline case study (Myriam Theeuwes) (PDF/2.65 MB)
First published: 16/03/2017
Last updated: 16/03/2017 -
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Presentation - Topic 3 - Clinical development strategies and trial designs for new TB treatment regimens (Carl Mendel) (PDF/136.69 KB)
First published: 16/03/2017
Last updated: 16/03/2017 -
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Presentation - Topic 3 - Evaluation of new treatment regimens, a clinicians perspective (Andreas Diacon) (PDF/55.57 MB)
First published: 16/03/2017
Last updated: 16/03/2017 -
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Presentation - Topic 3 - WHO perspective (Christian Lienhardt) (PDF/1.83 MB)
First published: 16/03/2017
Last updated: 16/03/2017
To watch the broadcast click on 'Multimedia' tab.