2014 - Alicante - Spain

PAGE 2014: Other Topics
Terry Shepard

How European Regulators are Facilitating the Use of Modelling and Simulation: MSWG History, Activity and Future

Theresa Shepard (1), Jacob Brogren (2), Efthymios Manolis (3) and Robert Hemmings (1)

(1) Medicines and Healthcare products Regulatory Agency, London, UK, (2) Medical Products Agency, Uppsala, Sweden and (3) European Medicines Agency, London, UK

Objectives: The Modelling and Simulation Working Group (MSWG) was established in January 2013 to answer EMA’s commitment to increase the regulatory M&S competence in Europe by coordinating the expertise across member states to provide a consistent approach in product-related and methodology related discussions [1].

Methods: The MSWG is comprised of experts across member states with advanced knowledge of modelling and simulation methodology, hands on experience in computational techniques, such as population PK, PK/PD, PBPK (physiologically based pharmacokinetic) and complex statistical M&S.  Procedures are referred to MSWG from the Scientific Advice Working Party (SAWP), the Paediatric Committee (PDCO) and the Committee for Medicinal Products for Human Use (CHMP).  The MSWG provides feedback in the form of written reports during monthly meetings in parallel with SAWP plenary and discussion meetings.

Results: During 2013, a total of 59 procedures were referred by SAWP (54, including three qualification procedures), PDCO (4) and CHMP (1).  Most frequent applications of modelling and simulation included dose finding, dose recommendations and extrapolation.  Specific examples, including feedback on experience of documentation will be presented as well as other activities (e.g. development of guidelines) and collaborations (e.g. EFPIA).

Conclusions: The MSWG have begun to increase awareness and acceptance of modelling and simulation approaches across the European national authorities through their involvement in procedures to date.  CHMP endorses M&S as a systematic quantitative approach to support well informed drug development and regulatory decisions.  In the longer term, it is envisaged that integrated data analysis encompassing all stages of development, based on modelling and simulations, will be important during MAA assessment, with the objective to reduce uncertainties, inform the SmPC and optimise the risk management plan (RMP).  In addition it is expected that M&S (i.e. systems models) could serve as a knowledge management platform combining data across products which could be used to assist development and regulatory decisions. The MSWG, through published annual work plans will continue to work to facilitate the CHMP vision.

[1] 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>.
[2] CPT Pharmacometrics Syst. Pharmacol. (2013) 2, e31; doi:10.1038/psp/2013.7

Reference: PAGE 23 (2014) Abstr 3298 [www.page-meeting.org/?abstract=3298]
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