TOPRA symposium: Panel Discussion on Clinical Evidence Generation in Europe

It was wonderful to be able to participate in a panel discussion with Alexandra Pacurariu Claus M?ldrup Elisabeth Kasilingam Jerome de Barros at TOPRA that was expertly chaired by Denise Umuhire

Using DARWIN use cases and industry use cases, we discussed the value and challenges of using RWD, and also the learnings from the use cases, and also the role of EHDS. Claus and Elizabeth shared the perspectives of the NCA and patient organisations, which added additional dimensions to our discussions. A shout out to the audience as well, as there were great questions.

In addition to the use of RWD for regulatory decision making, I also mentioned the growing urgency to bridge clinical research and clinical practice, using pragmatic trials or embedding trials into clinical practice as a way of generating clinical evidence that may meet the need of multiple stakeholders including regulators and payors.

Also thanks to my EFPIA colleagues álmath Spooner Aneta Tyszkiewicz and the EFPIA team that developed the case studies.