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Lewis Sheiner


2019
Stockholm, Sweden



2018
Montreux, Switzerland

2017
Budapest, Hungary

2016
Lisboa, Portugal

2015
Hersonissos, Crete, Greece

2014
Alicante, Spain

2013
Glasgow, Scotland

2012
Venice, Italy

2011
Athens, Greece

2010
Berlin, Germany

2009
St. Petersburg, Russia

2008
Marseille, France

2007
København, Denmark

2006
Brugge/Bruges, Belgium

2005
Pamplona, Spain

2004
Uppsala, Sweden

2003
Verona, Italy

2002
Paris, France

2001
Basel, Switzerland

2000
Salamanca, Spain

1999
Saintes, France

1998
Wuppertal, Germany

1997
Glasgow, Scotland

1996
Sandwich, UK

1995
Frankfurt, Germany

1994
Greenford, UK

1993
Paris, France

1992
Basel, Switzerland



Printable version

PAGE. Abstracts of the Annual Meeting of the Population Approach Group in Europe.
ISSN 1871-6032

Reference:
PAGE 28 (2019) Abstr 9208 [www.page-meeting.org/?abstract=9208]


PDF poster/presentation:
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Oral: Other Topics


C-07 Kristin Karlsson Regulatory model-informed drug discovery and development in EU – News flash and examples

Kristin E. Karlsson(1),(3) and Flora Musuamba Tshinanu(2),(3)

(1) Swedish Medical Products Agency, Uppsala, Sweden, (2) Federal Agency for Medicines and Health Products, Brussels, Belgium, (3) EMA Modelling and Simulation Working Party

Objectives: To provide an update on modelling and simulation involvement in the EU regulatory activities and procedures and highlight the latest news regarding MIDD in EU regulatory framework and to present examples of procedures where model-based approaches were essential for decision making.

Overview/Description of presentation: The presentation will provide some key statistics on M&S related regulatory activities and highlight some regulatory documents where model-based approaches are described and promoted. Examples of documents that have been published within the last year are Extrapolation Reflection Paper[1], Modelling and Simulation Working Party Paediatric Q&A[2], and Guideline on the reporting of physiologically based pharmacokinetic modelling and simulation[3]. Furthermore, there is ongoing work within various aspects of paediatric drug development, and the strategy document EMA Regulatory Science to 2025.

The second part of the presentation will focus on EU regulatory examples where model-based approaches played a vital role in the development and authorization of medicinal products. There are numerous examples of where model-based approaches have proven to be pivotal for the benefit/risk assessment in a market authorization application. Other regulatory interactions with increasing visibility of model-based drug development are central scientific advices (through the Scientific Advice Working Party) and paediatric investigation plans (through the Paediatric Committee) will be highlighted.   



References:
[1] https://www.ema.europa.eu/en/documents/scientific-guideline/adopted-reflection-paper-use-extrapolation-development-medicines-paediatrics-revision-1_en.pdf
[2] https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/clinical-pharmacology-pharmacokinetics/modelling-simulation-questions-answers
[3] https://www.ema.europa.eu/en/about-us/how-we-work/regulatory-science-2025