Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies

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Date: 26/11/2018
Location: European Medicines Agency, London, UK

The aim of this workshop is to discuss scientific and regulatory approaches which could be used to facilitate development and preparation of robust quality data packages, to enable timely access to medicines for patients whilst assuring that patient safety and product quality are not compromised. 

Participants will look at specific industry case studies covering chemicals, biologicals and advanced therapies and experiences across different regions. 

EMA and the United States Food and Drug Administration (FDA) launched PRIME and Breakthrough Therapy schemes to strengthen their support to the development of medicines for unmet medical needs to help patients to benefit from these therapies as early as possible. This workshop is a joint collaboration between EMA and the FDA.

EMA will publish a report on the workshop and consider developing recommendations and further guidance for applicants based on the experience gained so far and the feedback received during the event.  

Those interested in participating are invited to register by 31 October 2018. Due to limited space available, EMA will allocate places on specific criteria. For more information, see the draft agenda.

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