Japanese Initiative for Education in Pharmaceutical Medicine and Clinical Research Training

Akiko Kishi, Ichiro Uchida, Daisuke Koide, Kyoko Imamura

Abstract

Development of new medicines has become increasingly difficult with less possibility of success in seeds-finding and ever rising operational costs. Failure to comply with ethical standards for human research protection also erodes social trust in clinical development. In order to develop competence of professionals in medicines development such as clinical investigators and drug development scientists, a variety of educational courses and training programs have been developed and executed worldwide. As Japan is no exception and shares the same concerns, significant governmental and non-governmental efforts have been made to invest in the development of academic educational courses and adherence to international standards. This article introduces examples of the adoption of technologies to realize a user-friendly and sustainable learning management as well as an adaptation of syllabuses and core curricula to meet international standards in the era of global medicines development.


Keywords

PharmaTrain; CLIC; CREDITS; JAPhMed; SMD; pharmaceutical medicine; learning management system; continuous education

Full Text:

PDF

References

PharmaTrain Manual Curriculum Standards and Best Practices ver. 2.0, 2014, n.d., viewed October 15 2016, < http://www.PharmaTrain.eu>

DiMasi JA, Grabowski HG, Hansen RW, 2016, Innovation in the pharmaceutical industry: New estimates of R&D costs, J Health Econ., May;47:20-33. doi: 10.1016/j.jhealeco.2016.01.012. Epub 2016 Feb 12..

Nosengo N, 2016, New tricks for old drugs, Nature, 534: 314-16

Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK., n.d., viewed October 15 2016,

Dubois D, Jurczynska A, Kerpel-Fronius S, et al. 2016, Fostering competence in medicines development: The IFAPP perspective, Frontiers in Pharmacology, vol. 7: 1-7, DOI 10.3389/fphar.2016.00377,

PharmaTrain Mastering Medicine Development, n.d., viewed October 15 2016,

Ono S, Tsutani K, Shibata T, et al. 2003, Clinical trials in Japan after implementation of the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) Guidelines, Pharmaceutical Development and Regulation, vol. 1: 81-89.

Pacific Bridge Medical, n.d., viewed September 28 2016,

University Hospital Medical Information Network Center, n.d., viewed September 28 2016, < http://www.umin.ac.jp/english/whatisumin.htm >

Clinical Data Interchange Standard Consortium, n.d., viewed September 28 2016,

< http://www.cdisc.org/>

Pharmaceuticals and Medical Devices Agency, n.d, viewed September 28 2016,

< http://www.pmda.go.jp/english/index.html>

Moodle, n.d., viewed September 28 2016,

< https://moodle.org/>

The Ethical Guidelines for Medical and Health Research Involving Human Subjects, Ministry of Health, Labour and Welfare, (Provisional Translation (as of March 2015)),

List of Swissethics recognized Research Ethics and GCP course providers

Statement of clinical investigator competence, APPI Consensus

Statement, Monitor, August 2011: 79–82

A European Syllabus for Training Clinical Investigators, European Science Foundation, July 2003, viewed Oct 24 2016,

Boeynaems J-M, Canivet C, Chan A, et al. 2013, A European Approach to Clinical Investigator Training, Frontiers in Pharmacology, vol. 4: 1-5, DOI: 10.3389/fphar.2013.00112,

eCLIC n.d., viewed Oct 20 2016,

Responsible Conduct of Research (RCR), CITI-Japan Program, n.d., viewed Oct 20 2016,

PharmaTrain Specialist in Medicines Development (SMD) Procedural Document, April 2014 n.d., viewed October 15 2016,

Silva H, Stonier P, Buhler F, et al. 2013, Frontiers in Pharmacology, 4: 1-8, DOI : 10.3389/fphar.2013.00105,


DOI: http://dx.doi.org/10.18063/jmds.v3i1.166
(18 Abstract Views, 12 PDF Downloads)

Refbacks

  • There are currently no refbacks.


Copyright (c) 2017 KYOKO IMAMURA

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.