Health Technology Assessment (HTA) is an instrumental part of the process in obtaining reimbursement and market access for pharmaceuticals and medical device products in countries around the world.
Statisticians have substantially contributed to meet the demands of these different agencies. However, it is apparent that much more can still be accomplished, especially when considering new data sources (molecular profiles and omics, sensors and wearables), advanced analytics, precision medicine, novel clinical decision support tools, and regulatory labels purely based on real world data.
This seminar will consist of presentations as well as moderated panel discussions with the experts to discuss 3 overarching HTA topics:
1. What has been accomplished in the last 10 years
2. What challenges will the scientific advances and new data sources create for different stakeholders:
- How will these affect clinical R&D and commercialization in the biopharmaceutical and medical device industry?
- How will regulators and HTA balance traditional clinical trials and new real world evidence?
- What will the impact be for patients and on society?
3. Where are the major gaps and what still needs to be done
The Basel Biometric Society (BBS) and the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) are pleased to host a scientific meeting on this relevant topic with experts from the pharmaceutical industry, academia and the European HTA bodies.