SMPMA3151U Regulatory Strategic Considerations during Global Drug Development

Volume 2013/2014
Education
The course provides comprehensive overview of regulatory strategic considerations and cenveys an understanding of the role of Regulatory Affairs Professionals in drug development in identifying key factors in the development of regulatory strategies, consultations with authorities and intellectual property rights.
Content

The first study element consists of the Medicademy module “Regulatory Strategic Considerations during Global Drug Development”. The key topics are:

- Draft regulatory strategies
- Development of target label
- Regulatory planning in submission step
- Intellectual property rights
- Pricing and reimbursement negotiation.

For further information please visit Medicademy homepage

The second study element is offered by the Faculty of Health and Medical Sciences. The definition of a case within the topic of Regulatory Strategic Considerations and the following project report will be supervised by maximal 4 hours. The final project report should contain 5-7 written pages (title page, tabel of content, abstract and litterature list excl). The project report must include:

- Title page
- Table of content
- Abstract
- Introduction including presentation of case relevant law frame and literature within regulatory strategic considerations during global drug development and definition of the case
- Discussion of case relevant law frame and literature within regulatory strategic considerations during global drug development
- Conclusions and future perspectives
- Literature list.

Learning Outcome
On completion of the course the participants should understand roles of regulatory experts in project teams and be able to make strategic considerations regarding regulatory plans and decisions within pharmaceutical drug development.
In order to apply for the course the applicant must have a relevant educational background at Bachelor level, e.g. a Bachelor 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 “Regulatory Strategic Considerations during Global Drug Development” which includes a two days residential module and approximately 1000 pages of self study. The module is followed by a written exam. For further information please visit 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 within the area of Regulatory Strategic Considerations.

In order to initiate the study element participants must have passed the Medicademy module.
  • Category
  • Hours
  • Exam
  • 4
  • Preparation
  • 79
  • Project work
  • 27
  • Total
  • 110
Credit
3 ECTS
Type of assessment
Written examination, 4 hours under invigilation
See Medicademy homepage
Exam registration requirements
See Medicademy homepage.
Marking scale
passed/not passed
Censorship form
No external censorship
Exam period
See Medicademy homepage
Criteria for exam assesment
See Medicademy homepage
Credit
1 ECTS
Type of assessment
Written assignment
The final project report should contain 5-7 written pages (title page, tabel of content, abstract and litterature list excl).
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 and literature search of which the most important and relevant to the case is selected and peoperly referenced

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

The participant demonstrates correct application of terms and law frames within the field og regulatory strategic considerations during global drug development

The participant demonstrates that she/he is mastering to combine central concepts and disciplines witin regulatory strategic considerations during global drug development in her/his analysis of the case

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

Grade 7

The participant has written an original project report which demonstrates thorough law frame and literature search of which the most relevant to the selected case has been properly referenced

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

The participant demonstrates fairly correct application of terms and law frames within the field of regulatory strategic considerations during global drug development

The participants demonstrates that she/he is mastering central concenps and disciplines within regulatory strategic considerations during global drug development and has the ability to relate those to the selected case

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

Grade 2

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

The participants demonstrates ability to understand, report and occasionaly evaluate relevant law frames and literature for the selected case

The participant demonstrates knowledge to apply terms and law frames within the field of regulatory strategic considerations during global drug development

The participant demonstrates that he/she understand central ceoncepts and disciplines within regulatory strategic considerations during global drug development of relevance to the selcted case

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