PREFER receives a positive qualification opinion from the European Medicines Agency
The PREFER project developed a framework with points to for method selection that can be used by industry, regulators and health technology assessment bodies for how to use patient preferences as input in medical product decision making. We asked the European Medicines Agency and EUnetHTA to coordinate the assessment of our framework and its points to consider for method selection and issue a public qualification opinion on how useful the PREFER approach is from the regulatory perspective. Join us on 9 June, when we present and discuss the opinion in an online event at 16:00 CEST.
This month, the CHMP, the European Medicines Agency's (EMA) committee responsible for human medicines, adopted a positive qualification opinion on the PREFER framework and points to consider for method selection for a patient preference study. In their discussion for a positive opinion, the CHMP stated that the framework is comprehensive and enables planning and conducting patient preference studies. The framework "may furthermore support interactions between industry, regulators (and HTA bodies/payers, as well as patients….[Additionally], the points to consider chapter can support designing future PPS to generate evidence on patients’ views with the goal of informing decision-making." The CHMP stress the importance of seeking regulatory scientific advice if such preference studies are being considered by sponsors to support a medical product's approval.
To learn more about the CHMP positive opinion, we invite you to join us as we discuss key findings from the process and potential future implications.
The 1-hour online event will occur on 9 June 2022 at 16:00 CEST.
Speakers:
- Rebecca Noel, PREFER Deputy Project Leader, Eli Lilly and Company
- Mireille Muller, Novartis
- Jürgen Kübler, QSciCon
- Kristin Bullok, Eli Lilly and Company
- Isabelle Huys, KU Leuven
- Brett Hauber, Pfizer
- Bennett Levitan, Janssen R&D, LLC
Panelists:
- Laura Lee Johnson, FDA CDER
- Irina Cleemput, KCE
- Isabelle Stoeckert, Head Regulatory Affairs, Bayer AG