COMMENTS: Filling the gap between pharmaceutical grade cannabinoid derivative production through RWE. FDA will need to tighten up it’s response to CBD products with legal cannabis production booming in the Continue Reading
Comments – Part of the EMA’s continued commitment to RWE in support of medicinal product utilisation. When you see regulators investing in infrastructure like this, you know they are serious Continue Reading
COMMENTS: Part of the growing trend for big pharma to secure bid data sources for their own use. IMPACT: A move in the right direction towards ‘regulatory grade’ RWE, READ Continue Reading
Quick Notes: CONTEXT: USA, IVDs, RWE, Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics (IVDs) IMPACT: step forward in providing the valuable information that IVD manufacturers and others Continue Reading
EXPERT NOTES: CONTEXT: EU, Commercial RWD Data Source IMPACT: Access to EU RWD, drive cutting edge improvements in patient outcome Time Taken = 3 mins QUOTES FROM SOURCE: 1. “NEW Continue Reading
EXPERT NOTES: CONTEXT: Decentralized Clinical Trials IMPACT: Enabling technology for ‘Decentralized Clinical Trials’ a.k.a ‘Virtual Trials’ Time Taken = 2 mins QUOTES FROM SOURCE: 1. “As mentioned earlier, COVID-19 has Continue Reading
EXPERT NOTES: CONTEXT: Cool Shit REACTIONS: Expert 1: “We are all doomed…someone turned on SkyNet and the AIs became self aware.”Expert 2: “Nice human interest story”Expert 3: “Centaurs guys, … Continue Reading
Quick Notes: *Within the report the “conditional marketing authorisations” and “monitoring in real-life” are the “go to” section to see what the post-authorisation obligations were and what the EMA is Continue Reading
