Regulatory Science, Meiji Pharmaceutical University

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LaboratoryDepartment of Regulatory Science, Division of Clinical Pharmacy | Laboratories | Research | Meiji Pharmaceutical University
Prof. MaedaHideki Maeda – My portal – researchmap

Department of Regulatory Science, Division of Clinical Pharmacy, Meiji Pharmaceutical University

Promote research on the strategic and efficient clinical development of effective and safe drugs and medical devices in a practical and scientific manner through research based on regulatory science in the development of drugs and medical devices and post-marketing.

1. Research on strategic and effective development of clinical development

We conduct research on the topic as follows.

  • Trial design endpoints (true endpoints and surrogate endpoints)
  • Procedure for clinical trials and post-marketing clinical studies
  • International comparisons and considerations of regulatory practices and guidelines for marketing approval
  • Biomarker studies
  • Consideration on possibility of regulatory approval using real world data
  • Investigate the relationship between drug and medical device prices and development strategies
  • Create a systematic methodology for the development of drugs and medical devices

2. Research on early patient access and drag lag

To organize and propose regulatory recommendations for early access to new drugs and medical devices for patients, we conduct research on drug lags, off-label use, compassionate use, etc. in Japan, Asia, EU and the United States.

3. Research on safety evaluation and compensation

We conduct research on post-marketing safety monitoring, safety measures, post-marketing surveillance, and compensation for adverse events, and investigate and sort out issues related to post-marketing drugs and medical devices.

4. Other

We also conduct research and study on performance evaluation of regulatory agencies, objective analysis of new drug and medical device clinical development, the role and organization of pharmaceutical companies in the healthcare industry, and industry-government-academia collaboration.