Description
Recent US and European initiatives reflect a growing policy consensus favoring greater clinical trials and research transparency. New legislation, publishers and industry-driven projects promote independent verification of drug data, which provides a better framework for international collaboration. Greater transparency also increases public trust in research results, drugs and industry and the possibility of facilitating large cross-border clinical trials. Yet, the costs and concerns associated with opening up research and clinical trial data are also significant—for patients (protection of personal data and patient privacy), for research (misuse of clinical trial data) and for technology transfer and commercialization (obstacles to IP protection and increased exposure to litigation). This presentation will discuss these issues from an interdisciplinary perspective in order to sketch out legal mechanism that could be useful for unlocking and safe-guarding the full potential of greater transparency.| Period | 21 Apr 2016 |
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| Event title | The Future Directions in Regulatory Science: Regulatory Intelligence Gathering and Education: How to stay current on trends and events |
| Event type | Conference |
| Location | Copenhagen, DenmarkShow on map |
Keywords
- Regulatory sciences, pharmaceuticals, challenges