SMPMIF091U The Regulatory Affairs in Japan

Volume 2013/2014
Content

The firststudy element consists of the Medicademy module “The regulatory affairs environments in Japan”. The key topics are:

- Introduction to Japanese culture
- The Japanese Ministry of Health, Labor and Welfare (MHLW)
- Pharmaceutical legislation in Japan
- Case study on successful Japanese regulatory affairs strategy
- Chemical pharmaceutical documentation requirements (CMC)
- Clinical studies in Japan
- Japanese drug application including an effective summary (GAIYO/CTD)
- Typical differences between Japanese and EU/US requirements

For further information please visit the Medicademy homepage

The second study element is offered by Department of Pharmacy. The definition of a case within the topic of the regulatory affairs in Japan and the following project report will be supervised by at maximum of 7 hours. The final project report should contain 7-10 written pages (excl. title page, table of content, abstract and literature list). The project report must include:

- Title page
- Table of content
- Abstract
- Introduction includes presentation of the case/topic, the relevant Japanese low frame, guidelines, literature and data related to the case/topic

- Discussion includes analysis and balanced discussion of relevant Japanese law frame, guideline, literature and data related the case/topic
- Conclusions and future perspectives
- Literature list

Learning Outcome
The course aims to provide a comprehensive knowledge with regard to understand, apply, analyze, discuss and describe key elements in Japanese regulatory affairs from a drug substance in early development to post approval.

On completion of the entire course the participants are aimed to be able to understand, apply, analyze, discuss and describe key elements of Japanese legislation.
In order to apply for the course the applicant must have a relevant educational background at Bachelor level, e.g. a Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutics, Health Science, Technical Science or equivalent. The applicant should have at least 2 years experience within Drug Regulatory Affairs or equivalent qualifications. Further more, applicants must be able to understand, speak, read and write English at an advanced level.
The course consists of the following 2 study elements:

1) The Medicademy module “The regulatory affairs environment in Japan” which includes a two-three days residential module and approximately 1500 pages of self study. The module is followed by a written exam. For further information please visit the Medicademy homepage

2) An individual project report which is written under the guidance of supervisors at The Faculty of Health and Medical Sciences. As part of the study element participants must define a relevant case/topic within the area of regulatory affairs in Japan.

In order to initiate the study element participants must have passed the Medicademy module.
  • Category
  • Hours
  • Exam
  • 1,5
  • Lectures
  • 18
  • Project work
  • 29
  • Project work
  • 55
  • Total
  • 103,5
Credit
1,7 ECTS
Type of assessment
Written examination, 1,5 hours under invigilation
See Medicademy homepage
Exam registration requirements
See Medicademy homepage
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment

See Medicademy homepage

Credit
2 ECTS
Type of assessment
Written assignment
The final project report should contain 7-10 written pages (excl. title page, table of content, abstract and literature list).
Marking scale
7-point grading scale
Censorship form
No external censorship
Criteria for exam assesment


The grade awarded for the project report constitutes the grade awarded for the course in its totality.

Grade 12

The participant has written an original project report which demonstrate thorough and complete law frame, literature and data search of which the most important and relevant to the case/topic is selected and properly referenced.

The participant demonstrates that he/she masters to analyze, recapitulate critically evaluate and describe the most important and relevant law frames, literature and data for the selected case/topic

The participant demonstrates correct application of terms and law frames within the regulatory affairs in Japan.

The participant demonstrates that he/she is mastering to combine central concepts and disciplines within Japanese regulatory affairs to his/her analysis of the topic/case

The participant has written a coherent project report in which the various subtopics of the selected case/topic are excellently balanced and perform within the size limits and frame of the project report

Grade 7

The participant has written a original project report which demonstrate thorough law frame, literature and data search of which the most relevant to the selected case/topic has been properly referenced

The participant demonstrates ability to analyze, recapitulate, partly evaluate and describe relevant law frames and literature for the selected case/topic

The participant demonstrates fairly correct application of terms and law frames within Japanese regulatory affairs

The participant demonstrates that he/she is mastering central concepts and disciplines within Japanese regulatory affairs and has the ability to relate those to the selected case/topic

The participant has written a coherent project report in which the various subtopics of the case/topic is properly balanced and perform within the size limits and frame of the project report

Grade 02

The participant has written a project report in his/her own words which demonstrate a satisfactory law frame, literature and data search of which some of the most relevant to the selected case has been referenced.

The participant demonstrates ability to understand, report, occasionally evaluate and describe relevant law frames and literature for the selected case/topic

The participant demonstrates knowledge to apply terms and law frames within the Japanese regulatory affairs

The participant demonstrates that he/she understands central concepts and disciplines within Japanese regulatory affairs of relevance to the selected case/topic.

The participant has written a project report in which important subtopics of the case/topic is described within the size limits and frames of the project report