Human Medicines | Symposium 2022 | Collections

Human Medicines Stories

HM1: A decade of innovative clinical trials: What have we learned and where are we going?
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.
HM2: Are expedited programmes delivering on the promise to accelerate drug development and patient access?
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.
HM3: Lessons learned and strategic priorities
2022-12-05T00:19:00+00:00By Sobhey Nassar
The profession needs to adapt to the power of technology and the widespread dissemination of misinformation on social media is causing real-world harm.
HM4: Assessing the value of innovative therapies: trends, challenges and learnings
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.
HM5: Digital health opportunities and advancements in healthcare
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.
HM6: Innovation in regulatory science – The path from data to evidence and the promise to streamline the regulatory lifecycle
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.
HM7: Are patients the missing piece in the global drug development puzzle?
2022-12-05T00:15:00+00:00By Sarah Heraghty
This session focused on patient engagement from different stakeholder perspectives.
HM8: The present and future of developing and commercialising cell and gene therapies in a global world
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.
HM9: Strategy under uncertainty — Improving the odds of regulatory success
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.