2022-12-05T00:21:00+00:00By Frederic Pailloux
The session gave some insight on the Accelerating Clinical Trials in the EU (ACT EU) and the EMA Q&As on CCTs, a guidance regarding scientific aspects and the planning, set-up and submission for CTA applications, as well as conduct, reporting, analysis and interpretation of CCTs.
2022-12-05T00:20:00+00:00By Segolene Saintpierre
Expedited programmes available in the US, Europe and UK all aim to streamline process and ensure early access of medicinal products to patients; however, they are not yet fully delivering on their promises.
2022-12-05T00:18:00+00:00By Claire Levee
This session focused on the evolution of the European Medicines Agency (EMA) and The European Network for Health Technology Assessment (EUnetHTA) collaboration.
2022-12-05T00:17:00+00:00By Celia Cruz
There are still many unanswered questions due to the silos between medicines and medical devices and there is a need for interdisciplinary cooperation – stakeholders with different skills – to optimally position Europe for innovation.
2022-12-05T00:16:00+00:00By Segolene Saintpierre
There is a global evolution in drug development and RWE policy, increasing contribution of RWD/RWE to clinical evidence generation.
2022-12-05T00:15:00+00:00By Sarah Heraghty
This session focused on patient engagement from different stakeholder perspectives.
2022-12-05T00:14:00+00:00By Nathalie Bourrit
Gene therapies are highly innovative products which have been approved only for the treatment of rare diseases so far. Changes in manufacturing processes during development as well as difficulties in gathering large clinical data sets explain the common challenges encountered by gene therapy developers to demonstrate the benefit of their ATMP.
2022-12-05T00:13:00+00:00By Francesca Buttigieg
Following last year’s success, Daniela Drago, Carlos Langezaal and Fortunato Fred Senatore were back to conduct another interactive session. Attendees gathered into groups to discuss and propose regulatory strategies based on a number of scenarios, three of which will be described here.
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