Building HTA insights into the drug development plan: current approaches to seeking early scientific advice from HTA agencies.
Sign Up to like & getrecommendations! Published in 2021 at "Drug discovery today"
DOI: 10.1016/j.drudis.2021.09.014
Abstract: There is a growing trend for pharmaceutical companies to seek scientific advice on drug development from a Health Technology Assessment (HTA) perspective, to improve the efficiency of their studies, enable better trial design, and support… read more here.
Keywords: hta; drug development; scientific advice; advice ... See more keywords
On the importance of clarity in scientific advice for fisheries management
Sign Up to like & getrecommendations! Published in 2018 at "Marine Policy"
DOI: 10.1016/j.marpol.2017.10.029
Abstract: Abstract Fisheries management is a difficult process that requires policymakers and scientists to work in concert with one another to set quotas or other management actions that conserve fisheries resources for long-term use. Policymakers take… read more here.
Keywords: advice; scientific advice; management; fisheries management ... See more keywords
COVID-19 and the Paradox of Scientific Advice
Sign Up to like & getrecommendations! Published in 2021 at "Perspectives on Politics"
DOI: 10.1017/s1537592721001201
Abstract: The scientific advisory committee is a neglected political institution whose importance became clear during the COVID-19 pandemic. What I call "the paradox of scientific advice"consists in that the two basic expectations from scientific advisory committees… read more here.
Keywords: paradox scientific; covid paradox; scientific advice; committee ... See more keywords
The Added Value of Patient Engagement in Early Dialogue at EMA: Scientific Advice as a Case Study
Sign Up to like & getrecommendations! Published in 2022 at "Frontiers in Medicine"
DOI: 10.3389/fmed.2021.811855
Abstract: The European Medicines Agency provides Scientific Advice to medicines developers and patient input has been an integral part of this process for many years. As end users of medicines, patients bring their perspectives to many… read more here.
Keywords: scientific advice; advice case; case study; value ... See more keywords
Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency
Sign Up to like & getrecommendations! Published in 2022 at "Frontiers in Medicine"
DOI: 10.3389/fmed.2022.893028
Abstract: With the implementation of the new EU regulation on in vitro diagnostics (IVDR) in May 2022, notified bodies will be required to assess Companion Diagnostics (CDx). The EMA and national medicines agencies will be consulted… read more here.
Keywords: advice; marketing authorization; scientific advice; cdx ... See more keywords