EJP RD advanced Webinar - Real World Data, Machine Learning & Deep analytics in Rare Diseases

Описание: Keynote presentations 
00:00:01 Marc Van Dijk (UCB): Data and technologies that offer solutions for challenges in rare diseases 
00:22:15 Luis Pinheiro (EMA): From Data to Decision 
Panel discussion (highlights on some questions discussed)
(Jose/patient, Cécile/regulatory science, Meelis/tech developer, Dinko & Tom/drug developers, Luis/regulator)
00:48:05 Points to consider when using new technologies to generate robust data 
01:01:27 Solutions to develop better data (technologies and examples)
01:03:30 Synthetic data (part 1: context of use, value)
01:06:40 AI doctor (scientific and regulatory validation)
01:07:22 Synthetic data (part 2: regulator's perspective)
01:08:27 AI doctor (acceptability of technologies, patient perspective)
01:10:35 Conventional methods vs. New technologies and methods 
01:12:02 Data protection aspects when generating regulatory evidence
01:13:36 Pre-competitive collaboration to de-risk and accelerate progress 
01:15:55 Evolution of technology and its limitation 
01:18:12 Blockchain in drug development 
01:19:20 Key principles/imperatives from understanding the disease up to regulatory context
01:28:45 Interplay between medicines and medtech and AI regulations
01:31:50 Patient perspective on digital health technologies 
01:33:05 Take home message - recommendations from the panel