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The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop.

ABSTRACT: 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.

SUBMITTER: Manolis E

PROVIDER: S-EPMC3600760 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop.

Manolis E E Rohou S S Hemmings R R Salmonson T T Karlsson M M Milligan P A PA

CPT: pharmacometrics & systems pharmacology 20130227

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 ...[more]

PMID: 23835942

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Project description:Background:Simulation-based education (SBE) is increasingly endorsed as an educational strategy. It allows health-care professionals to practice clinical skills within a safe learning environment, and requires devices for simulation or simulated patients, trained teachers, and an appropriate environment. The objective of this study was to evaluate perceptions of participants on SBE and an SBE workshop. Methods:A 1-day SBE workshop was conducted on September 4, 2018, in collaboration with Laerdal Global Health Nepal and the National Centre for Health Professions Education (NCHPE), Institute of Medicine, Kathmandu, Nepal. Semistructured pretest and posttest questionnaires were used to evaluate the perceptions of participants regarding SBE and the effectiveness of the workshop. Data were analyzed using SPSS 21. Results:The mean difference in participant perceptions of SBE before and after participation in the workshop was significant (P<0.05) on seven statements: enhances communication skills (pretest 4.53±0.72, posttest 4.84±0.75; P=0.03), helps in seeing and managing even rarest of cases (pretest 3.59±1.00, posttest 4.21±0.92; P=0.02), overcomes the problem of uncooperative patients (pretest 3.12±0.93, posttest 3.95±1.22; P=0.004), increases confidence of students in dealing with real patients (pretest 4.29±0.77, posttest 4.79±0.42; P=0.041), enables preparation of rating scales for skills and attitude evaluation (pretest 3.76±0.83, posttest 4.11±0.76; P=0.049), provides immediate feedback during simulation (pretest 4.06±0.9, posttest 4.58±0.51; P=0.016), and keeps materials/equipment ready before simulation (pretest 4.29±0.68, posttest 4.79±0.53; P=0.007). Mean scores for participant feedback on the workshop using a Likert scale of 1-5 (5= strongly agree, 1= strongly disagree) were notable: objective of workshop fulfilled (4.16±0.688), session very interesting (4.37±0.597), session useful for future job (4.47±0.513), scenario relevant to subject (4.21±0.787), what I learnt will be useful in practice (4.05±0.78), resource persons/facilitators were helpful and effective (4.37±0.597), professional (4.42±0.507), and answered all questions (4.32±0.478), and course content was presented clearly (4.26±0.452). Almost all participants found the workshop useful and well presented, and suggested conducting such workshops frequently. Conclusion:The SBE workshop produced substantial differences in perceptions of participants. Participants found the workshop effective in improving knowledge and understanding of SBE.

Dataset Information

The Role of Modeling and Simulation in Development and Registration of Medicinal Products: Output From the EFPIA/EMA Modeling and Simulation Workshop.

Publications

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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