Author: "Norbert Benda" / Publisher: elsevier - Searchworks@Jio Institute Digital Library Search Results

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Author: Abrar Alturkistani, Juanjuan An, Norbert Benda, Karina Bienfait, Adele R. Blackler, Martin Bøgsted, David Brindley, Karl Broich, Rasmus F. Brøndum, Patrick Brunhoeber, Matthew Bureau, Josip Car, Alison Carter, Tara Clarke, June Clements, Darren Cross, Brett Doble, Marisa Dolled-Filhart, Elena Domazetoski, Mark W. Duncan, Ehab A. ElGabry, Aaron R. Ellison, Kenneth Emancipator, Harald Enzmann, Maria Farooq, Janine Feng, Kimberley Foley, Evgenii Generalov, Ning Fei Go, Alexey Goltsov, George A. Green, Maria Hersom, Narimon Honarpour, Lahiru Iddamalgoda, Masayuki Ikeda, Suzanne Jenkins, Jan Trøst Jørgensen, Monesh Kapadia, Sylwia Karwowska, Sebnem S. Kuzulugil, Ching Lam, Jason S. Lewis, Jinbo Li, Oliver Liesenfeld, Gilberto Lopes, Dee Luo, Edward Meinert, Ralf Meyer, Amita Mistry, Nicholas Mitsakakis, Jens Mollerup, Michael C. Montalto, Lauren B. Murata, Muhammed Murtaza, Karsten Bork Nielsen, Saumya Pant, Jayson L. Parker, Patrícia M.R. Pereira, Manjunath Ramarao, Ted Rigl, Oliver Schildgen, Verena Schildgen, Catharina Scholl, Sidney A. Scudder, Donna Seyfried, Abha Sharma, Rumiko Shimazawa, Richard Simon, Shalini Singh, Nicholas B. Sobol, David A. Stanforth, Julia Stingl, Vijayaraghava Seshadri Sundararajan, Prashanth Suravajhala, Alessandra Tosolini, Jeff Tsou, Kathryn M. Tully, Eric E. Walk, Dianna Wu, Xiaolei Xu, and Karen Yu
Published: 2019
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Author: Karl Broich, Julia C. Stingl, Norbert Benda, Ralf Meyer, Harald Enzmann, and Catharina Scholl
Subjects: Biomarker, business.industry, Agency (sociology), media_common.cataloged_instance, Accounting, Business, Certification, European union, In vitro diagnostic, media_common
Abstract: In the European Union (EU), responsibilities for medicines and companion diagnostics (CDxs) are divided. The European Medicines Agency (EMA) and national agencies approve medicines, whereas notified bodies (NBs) certify CDx. The EU regulation on in vitro diagnostic medical devices of 2017 mandates NBs to consult regulatory authorities, usually the EMA, during the certification of a CDx. This consultation is required for an innovative CDx based on a new biomarker and introduced together with an innovative medicine, as well as for any new “generic” CDx for the same well-known biomarker and using the same methodological approach as an established reference CDx. EMA’s view how the CDx affect the benefit–risk balance of the corresponding medicines may well change NBs’ certification decisions. This chapter delineates EMA’s current and possible future principles in the assessment of the impact of CDx on the benefit–risk balance of medicines.
Published: 2019
Full Text: View/download PDF

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