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EMA workshop on pre-licencing activities

March 9, 2016

In collaboration with EMA, E-Rare will organize a workshop dedicated to Interactions between EMA and RD researchers on pre-licensing activities. The workshop will take place on the 9 of March 2015 in Barcelona, Spain, before the official start of the RE(ACT) meeting. It will be open to all researchers and interested stakeholders.

The program will include 4 sessions:

•  Pre-licensing activities of EMA with the presentation of relevant EMA services (COMP, SAWP, PDCO, CAT).
•  Orphan designation and incentives for researchers including information on how to submit OD and Protocol assistance – how it works.
•  Lessons learnt from Horizon 2020 success stories on obtaining an OD.
•  Face-to-face meetings with EMA officers – session dedicated to researchers that already prepared a draft submission package for OD or protocol assistance.

The places for Face-to-face meetings with EMA officers are limited so if you would like to participate, please send an email to Juliane Halftermeyer for further details.


March 9, 2016



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