On Tuesday 7 May at 12:00 Maximilian Salcher-Konrad will hold a guest lecture titled 'Conditional approval of cancer drugs in Europe and the United States: a matched comparison' in the Senate Hall at Rīga Stradiņš University (RSU).
European and US medicinal products regulators commonly use conditional pathways for approval of cancer drugs with preliminary evidence about their benefit-risk profile, requiring additional evidence to be collected. While EMA and FDA have similar conditional approval pathways at their disposal, there appear to be differences in their use, suggesting differential approaches to handling uncertainty in the approval of new medicines. Using a sample of 21 matched drug-indication pairs with conditional approval by the EMA, FDA, or both, we reviewed pivotal trial evidence, regulatory approval pathways, approved indications, and post-marketing obligations to assess differences in evidence standards, regulatory processes, pathways, and outcomes between the two agencies.
This study was conducted by Maximilian Salcher-Konrad (London School of Economics and Political Science) and Courtney Davis (King’s College London).
About the guest lecturer
Maximilian Salcher-Konrad (pictured) is a PhD student in the Department of Health Policy at the London School of Economics and Political Science (LSE) and a Research Officer at the Personal Social Services Research Unit and LSE Health. He holds an MSc in Health Policy, Planning and Financing from LSE and the London School of Hygiene and Tropical Medicine. His research is focused on evidence requirements for drug marketing authorisation, comparative effectiveness research and the role of randomised and non-randomised studies, as well as evidence synthesis for decision-making.
The lecture is organised by the RSU Institute of Public Health and the Faculty of Pharmacy.
The research is funded by Stichting Health Action International and the lecture is funded by Jean Monnet European Centre of Excellence.