The Regulatory Affairs Environment in the USA

Course content

The first study element consists of the Medicademy module “The Regulatory Affairs Environment in the USA”. The key topics are:

- Overview of various regulatory submissions

- Project development plans

- Communication with FDA during drug development, prior to submission, during review and post approval

- Clinical/nonclinical and quality requirements for the IND and NDA

- Abbreviated new drug applications (ANDA’s)

- Medical device/drug combination products

- Fast tract development, accelerated approvals, orphan drugs FDAMA and PDUFA I, II and III

For further information please visit the 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 affairs in the USA 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, statement of purpose, as well as description of relevant USA/FDA pharmaceutical law frame, guidelines, literature and data related to the case/topic
- Discussion includes analysis and balanced discussion of relevant USA/FDA pharmaceutical law frame, guideline, literature and data related the case/topic
- Conclusions and future perspectives
- Literature list

Education

Master of Phamaceutical Regulatory Affairs

Learning outcome

After completing the course the student is expected to be able to:

Knowledge

  • Explain and discuss pharmaceutical law frames in the USA from a drug substance in early development to post approval

Skills

  • Apply, analyze and consider pharmaceutical law frames in the USA from a drug substance in early development to post approval

  • Present data and results in the new drug application (NDA) from efficacy and safety studies

  • Organize, discuss and communicate a scientific problem in the form of a written project report

The course consists of the following 2 study elements:

The Medicademy module “The Regulatory Affairs Environment in the USA” which includes a 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

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 the USA.

In order to initiate the study element participants must have passed the Medicademy module.

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.

ECTS
See exam description
Type of assessment
Other, 3-4 hours under invigilation
“The Regulatory Affairs Environment in the USA”, 1,75 ECTS, 3-4 hours written exam, passed/failed.

Written project report, 2 ECTS, 7-point scale, no external censorship.
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

For further information please visit the Medicademy homepage

ECTS
See exam description
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 assessment

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 and literature for the selected case/topic

The participant demonstrates correct application of terms and law frames within the field of regulatory affairs in the USA

The participant demonstrates that he/she is mastering to combine central concepts and disciplines within regulatory affairs in the USA 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 the field of regulatory affairs in the USA

The participant demonstrates that he/she is mastering central concepts and disciplines within the regulatory affairs in USA 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 demonstrates 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 field of regulatory affairs in USA

The participant demonstrates that he/she understands central concepts and disciplines within regulatory affairs in the USA 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

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 22
  • Lectures
  • 22
  • Project work
  • 55
  • Exam
  • 4
  • English
  • 103