The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop
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The European Medicines Agency (EMA) and the Federation of Pharmaceutical Industries and Associations (EFPIA) hosted a workshop on modeling and simulation (M&S).1 Representatives from industry, academia, and regulatory agencies from Europe and beyond discussed the role of M&S in the development and registration of medicinal products within plenary and breakout sessions (BOS). This manuscript summarizes the plenary discussion (Table 1) focusing on the European perspective. Deliverables from each BOS are included in separate papers. CPT: Pharmacometrics & Systems Pharmacology (2013) 2, e31; doi:10.1038/psp.2013.7; advance online publication 27 February 2013
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An overarching framework for modeling and simulation in regulatory decision making was proposed for drug development.
“An overarching framework for modeling and simulation in regulatory decision making was proposed for drug development.12”
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- European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop report. < http://www.ema.europa.eu/docs/en_GB/ document_library/Report/2012/05/WC500127118.pdf >
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- Authors
- Manolis, E., Rohou, S., Hemmings, R., Salmonson, T., Karlsson, M., & Milligan, P.
- Affiliations
- European Medicines Agency (NL)
- Global Medicines Development, Regulatory Affairs, AstraZeneca R&D London UK
- Uppsala University (SE)
- Pfizer, Pharmacometrics, Global Clinical Pharmacology Sandwich UK
- Corresponding author
- Manolis, E
- ORCID
- Karlsson, M
- Venue
- CPT: Pharmacometrics & Systems Pharmacology
- Publisher
- Wiley
- Published
- 2013-02
- Volume
- 2
- Issue
- 2
- Pages
- 1-4
- ISSN
- 2163-8306 (ISSN-L)
- PMC
- PMC3600760
- OpenAlex
- W2059056324
- Cited by
- 70
- References
- 7
- Citations by year
- 2026: 3 · 2025: 2 · 2024: 5 · 2023: 4 · 2022: 4 · 2021: 13 · 2020: 4 · 2019: 5 · 2018: 6 · 2017: 6 · 2016: 5 · 2015: 2 · 2014: 2 · 2013: 9
- FWCI
- 5.58
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- CPT Pharmacometrics & Systems Pharmacology (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Computer Science › Computational Theory and Mathematics › Computational Drug Discovery Methods
- Keywords
- modeling and simulation, regulatory science, drug development, drug registration, European Medicines Agency, EFPIA, European perspective
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