Real World Evidence, Real World Industry
By Nige Hughes
A podcast by pharmaceutical industry colleagues on contemporary topics of relevance related to utilisation of Real World Health Data and generation of Real World Evidence
Real World Evidence, Real World IndustryDec 01, 2021
00:00
39:57
A discussion on the content and impact of recent FDA consultative guidance in RWD/RWE
In this first episode of the podcast, the panel debate the recent guidance from the FDA, out for consultation:
- Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products [link]
- Data Standards for Drug and Biological Product Submissions Containing Real-World Data [link]
We cover our views on the guidance, the drivers for them, what we believe will be most impactful, and conversely where we believe improvements could be made, and lastly the ultimate impact of them in raising the importance of RWD/RWE in decision-making internationally.
We hope you enjoy this first episode and look forward to new ones in the New Year.
Dec 01, 202139:57