Second international awareness session for international regulators, academia and non-governmental organisations
Date:
08/03/2018 to 09/03/2018
Location:
European Medicines Agency, London, UK
This two-day awareness session for international regulators , academia and non-governmental organisations (NGOs) will give an insight into how the European medicines regulatory network works, the role of European Medicines Agency (EMA), scientific aspects of EMA's work and its interaction with scientific experts. It will address topics including the role of experts and benefit-risk evaluation. It will also provide networking opportunities with academics, NGOs staff and regulators from and outside the European Union. The event will be broadcast live. EMA will publish further material after the event.
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Agenda - Second international awareness session for international regulators, academia and non-governmental organisations (PDF/359.25 KB)
First published: 18/12/2017
Last updated: 13/02/2018
EMA/829042/2017 -
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Presentation - Module 1 - Setting the scene: Introduction to the EU regulatory network (PDF/2.47 MB)
First published: 28/03/2018
Last updated: 28/03/2018 -
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Presentation - Module 2 - Engagement with stakeholders (PDF/2.18 MB)
First published: 26/03/2018
Last updated: 26/03/2018 -
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Presentation - Module 3 - Early engagement on medicine development (PDF/2.2 MB)
First published: 28/03/2018
Last updated: 28/03/2018 -
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Presentation - Module 4 - Advanced therapy medicinal products (ATMPs) (PDF/1.38 MB)
First published: 28/03/2018
Last updated: 21/09/2018 -
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Presentation - Module 5 - Clinical trials in the European Union (PDF/1.02 MB)
First published: 28/03/2018
Last updated: 28/03/2018 -
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Presentation - Module 6 - EMA support to innovation (PDF/2.09 MB)
First published: 28/03/2018
Last updated: 28/03/2018 -
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Presentation - Module 7 - Benefit-risk assessment and good regulatory practice (PDF/2.24 MB)
First published: 28/03/2018
Last updated: 28/03/2018 -
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Presentation - Module 8 - Dealing with specific populations and types of products (PDF/1.21 MB)
First published: 28/03/2018
Last updated: 28/03/2018 -
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Presentation - Module 9 - Good practice and inspections (PDF/3.12 MB)
First published: 28/03/2018
Last updated: 28/03/2018 -
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Presentation - Module 10 - Patient safety and pharmacovigilance (PDF/2.43 MB)
First published: 28/03/2018
Last updated: 28/03/2018 -
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Presentation - Module 11 - International cooperation (PDF/1.63 MB)
First published: 28/03/2018
Last updated: 28/03/2018