Tailored scientific advice to support step-by-step development of new biosimilars

16 December 2016 - Pilot project to commence in February 2017. ...

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EMA hosts workshop on adaptive pathways

13 December 2016 - Broad range of stakeholder questions addressed. ...

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Twelfth joint EMA/EUnetHTA dialogue meeting

5 December 2016 - The 12th joint meeting between the EMA and the European network for Health Technology Assessment (EUnetHTA) will ...

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Development challenges for medicines for central nervous system disorders

29 November 2016 - EMA conducts analysis of applications submitted between 1995 and 2014. ...

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Workshop: towards new treatments for tuberculosis

18 November 2016 - The event will be broadcast on 25 November 2016. ...

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How can clinical research networks support developers of medicines for children?

16 November 2016 - Event to be broadcast live on 1 December 2016. ...

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The European Commission launches a public consultation on the Paediatric Regulation

15 November 2016 - This marks ten years since the legislation entered into force. ...

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Revising the guideline on first-in-human clinical trials

15 November 2016 - Changes are open for comments until end of February 2017. ...

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Modelling and simulation in the development of medicines

14 November 2016 - Watch live broadcast of expert discussion at EMA. ...

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How to facilitate development of cancer treatment based on genetically modified T-cells

8 November 2016 - Watch live broadcast of expert discussion at EMA. ...

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How big data can be used for the development and regulation of medicines

8 November 2016 - EMA workshop broadcast live on 14-15 November. ...

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Opening up clinical data on new medicines

20 October 2016 - EMA provides public access to clinical reports. ...

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EMA updates list of PRIME priority medicines

19 October 2016 - The EMA has added three new technologies to the list following last week's CHMP meeting. ...

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Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards

19 October 2016 - Measures of health-related quality of life and other patient-reported outcomes generate important data in cancer randomised trials ...

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EU-US collaboration to boost medicine development for rare diseases

26 September 2016 - The EMA and the U.S. FDA have set up a new ‘cluster’ on rare diseases to share ...

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