Send a message to the show! The Identification of Medicinal Products (IDMP) standards promise to harmonise how pharmaceutical products and substances are described around the world. But how will that benefit patients and who will make sure the standards are properly implemented? Uppsala Monitoring Centre’s Malin Fladvad and Olle Lagerlund discuss the advanta ... Show More
Feb 2026
#44 Rethinking medical device safety, part 2 – Omar Aimer
Send a message to the show!Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk. In this two-part episode, Omar Aimer, President of ISoP and former co ... Show More
21m 22s
Mar 2023
Using Real-World Studies to Compare DMTs in MS
Tomas Kalincik, Head of the Clinical Outcomes Research Unit at the University of Melbourne, and Maria Pia Sormani, Professor of Biostatistics at the University of Genoa, discuss the use of real-world data to compare disease-modifying treatments (DMTs) in multiple sclerosis, inclu ... Show More
24m 43s
Mar 2022
QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices
FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device ind ... Show More
48m 59s
Oct 2021
How to Interpret and Use a Clinical Practice Guideline
<p>Romina Brignardello-Petersen, DDS, PhD, and Gordon Guyatt, MD, of McMaster University talk with JAMA Executive Deputy Editor Robert Golub, MD, about how to interpret clinical practice guidelines and recommendations, the subject of a recent Users' Guides to the Medical Literatu ... Show More
32m 32s