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Japanese Institute for Public Engagement
It stands for Specialist in Medicines Development.
The SMD program was launched in 2016 as a joint project by the International Federation of Associations of Pharmaceutical Physicians (IFAPP) and Pharmaceutical Medicine, a non-profit organization that promotes and educates the public about pharmaceutical medicine, starting with the development of drugs and leading to their proper use in the market. The SMD program was launched in 2016 as a joint project by the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), a non-profit organization that promotes and educates the public about pharmaceutical medicine, which begins with drug development and leads to its proper use in the marketplace, and PharmaTrain, a European non-profit organization that accredits pharmaceutical medicine education courses in various countries.
Unlike conventional educational courses, which mainly focus on classroom lectures to acquire basic knowledge, this program assesses and develops participants' competencies in the workplace. As a result, certification will be issued to individuals who have reached the international curriculum standards set by IFAPP and PharmaTrain.
With the development of drugs for intractable diseases through innovations in drug discovery technology, and the combination of such drugs with medical devices and the development of regenerative medicine attracting attention, there is a growing need internationally for drug development specialists who can bridge the gap between pharmaceutical R&D and medical practice. On the other hand, many workplaces have not established systematic educational curriculums and evaluation standards, and it is not easy to identify and systematically develop human resources with excellent competencies. In business, where concrete results through actions as well as knowledge are required, objective competency evaluation and effective human resource development are becoming increasingly important.
Therefore, we decided to implement a pilot project in Europe and Japan in 2016. In Japan, the Japanese Society of Pharmaceutical Medicine, the Japan ACRP, and the European Federation of Pharmaceutical Manufacturers and Associations jointly participated in the project under the auspices of the Japanese Society of Clinical Pharmacology (in Europe, Italy started the introduction at the same time). After a trial introduction, the system has been in operation at the corporation since August 2020, and continues to be supported by the Japanese Society of Pharmaceutical Medicine, ACRP Japan, and the European Federation of Pharmaceutical Manufacturers and Associations.
In particular, those who have completed the new PharmaTrain educational course offered by the Japanese Society of Pharmaceutical Medicine and Osaka University are expected to obtain SMD certification by having their competency assessed in the workplace.
| Domain 1 | Discovery medicine & early development |
Design clinical development to identify unmet medical needs, evaluate new development candidates and create Target Product Profile |
| Domain 2 | Clinical development & clinical trials |
Plan, conduct, and evaluate exploratory and validation clinical trials, and prepare publications and regulatory submission documents |
| Domain 3 | Medicines Regulation |
Understand the pharmaceutical and legal systems necessary for clinical development to ensure appropriate use and risk management throughout the drug lifecycle |
| Domain 4 | Drug safety surveillance |
Evaluate and interpret post-marketing surveillance to provide appropriate information to patients and subjects and to minimize risks |
| Domain 5 | Ethics and subject protection |
Understand and act on the fundamentals of clinical trial ethics and business ethics in conducting clinical trials and commercial activities |
| Domain 6 | Healthcare Marketplace |
Understand and act on ethical and legal standards necessary for the protection of human subjects in the promotion of drugs and the planning of clinical trials |
| Domain 7 | Communication & management |
Demonstrate the people management and leadership skills necessary to achieve results through effective communication skills and interpersonal relationship building |
If you apply for the SMD program as a group (workplace unit), you can consider group participation according to the years of experience of the target employees.
If you apply for the SMD program in a group (workplace unit), you can participate in a group according to the number of years of experience of the target employees. For example, if you apply for the program in conjunction with the annual schedule of the participating company, you can incorporate the evaluation results of the SMD program into the personnel evaluation.