EMA event supporting materials
Table of contents
- Brochure on EMA's role in medicines regulation across the EU
- Timeline and brochure on the journey of a medicine from lab to patient
- Annual report on EMA's activities in 2022
- Brochures on medicines authorised via EMA in 2022
- How EMA contributes to tackling COVID-19
- EMA's responsibilities in overseeing clinical trials
- EMA's strengthened role in the veterinary field
- How EMA supports SMEs
- Guides for companies developing advanced therapies
- Report on EMA's work in the international arena
- Data analytics
- Pharmacovigilance
EMA has selected this series of key materials for attendees of DIA so that you have quick access to information about how EMA works and its recent initiatives.
Check our interactive timeline to learn about each stage a medicine goes through from initial research to patient access, and about how EMA supports medicine development, assesses the benefits and risks of medicines and monitors their safety.
To find out more, see:
Learn about the Clinical Trials Regulation, including how it overhauled the oversight of clinical trials in the EU, and EMA's new responsibilities in this area.
Read our news announcement on the entry into application of the Veterinary Medicinal Products Regulation to find out how the Regulation changed the rules on the authorisation and use of veterinary medicines in the EU, and to learn about EMA's strengthened role in the veterinary field.
To find out more, see:
To find out more, see
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Guide on advanced therapy medicinal products - Quality flowchart (PDF/144.33 KB)
First published: 29/11/2021
Version 1.0 -
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Guide on advanced therapy medicinal products - Non-clinical development flowchart (PDF/145.37 KB)
First published: 29/11/2021
Version 1.0 -
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Guide on advanced therapy medicinal products - Clinical development flowchart (PDF/147.32 KB)
First published: 29/11/2021
Version 1.0
To find out more, see:
To find out more, see:
- Ongoing clinical trials raw data pilot
- Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation
- Vaccine Monitoring Platform
- Guideline on registry-based studies
- Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use