Open AccessCommentary on the MID3 Good Practices Paper
Author(s) -
Manolis Efthymios,
Brogren Jacob,
Cole Susan,
Hay Justin L.,
Nordmark Anna,
Karlsson Kristin E.,
Lentz Frederike,
Benda Norbert,
Wangorsch Gaby,
Pons Gerard,
Zhao Wei,
Gigante Valeria,
Serone Francesca,
Standing Joseph F.,
Dokoumetzidis Aris,
Vakkilainen Juha,
van den Heuvel Michiel,
Mangas Sanjuan Victor,
Taminiau Johannes,
Kerwash Essam,
Khan David,
Musuamba Flora Tshinanu,
Skottheim Rusten Ine
Publication year - 2017
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.12223
Subject(s) - harmonization , documentation , consistency (knowledge bases) , agency (philosophy) , dialog box , working group , best practice , process management , political science , management science , operations research , public relations , computer science , engineering management , engineering , sociology , law , world wide web , social science , physics , artificial intelligence , acoustics , programming language
During the last 10 years the European Medicines Agency (EMA) organized a number of workshops on modeling and simulation, working towards greater integration of modeling and simulation (M&S) in the development and regulatory assessment of medicines. In the 2011 EMA – European Federation of Pharmaceutical Industries and Associations (EFPIA) Workshop on Modelling and Simulation, European regulators agreed to the necessity to build expertise to be able to review M&S data provided by companies in their dossier. This led to the establishment of the EMA Modelling and Simulation Working Group (MSWG). Also, there was agreement reached on the need for harmonization on good M&S practices and for continuing dialog across all parties. The MSWG acknowledges the initiative of the EFPIA Model‐Informed Drug Discovery and Development (MID3) group in promoting greater consistency in practice, application, and documentation of M&S and considers the paper is an important contribution towards achieving this objective.