SMPMA3141U Regulatory Affairs in the EU

Volume 2015/2016
Education
Master of Pharmaceutical Regulatory Affairs (MPRA)
Content

The firststudy element consists of the Medicademy module “The Pharmaceutical Law Frames in the EU”. The key topics are:

- The EU pharmaceutical legislation and law frame
- General background about the EU and its institutions
- EMEA, ICH and Ph.Eur.

The second studyelement consists of the Medicademy module “EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation”. The key topics are:

- The content of a marketing authorisation application
- EU registration procedures
- Scientific advice from CHMP and national authorities
- Orphan Medicinal products
- Other relevant applications
- Clinical trial applications

The third 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 EU 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 including the relevant EU pharmaceutical law frame, guidelines and literature related to the case/topic as well as presentation of the case/topic
- Discussion of relevant EU pharmaceutical law frame, guideline and literature related the case/topic
- Conclusions and future perspectives
- Literature list

Learning Outcome

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

Knowledge

  • Explain and discuss European pharmaceutical law frames

  • Explain and discuss European pharmaceutical legislation

Skills

  • Apply and analyze European pharmaceutical legislation

  • Analyse and consider the requirements for obtaining an marketing authorization application (MAA)

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

Competencies

  • Make plans for the needed documentation for applying for an MAA

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. Furthermore, applicants must be able to understand, speak, read and write English at an advanced level.
The course consists of the following 3 study elements:

1) The Medicademy module R1 “The Pharmaceutical Law Frames in the EU” 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 the Medicademy homepage.

2) The Medicademy module R2 “EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation” which includes a 2 days residential module and approximately 1000 pages of self study. The module is followed by a written exam. For further information please visit the Medicademy homepage.

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

In order to initiate the third study element participants must have passed both Medicademy modules.
  • Category
  • Hours
  • Exam
  • 3,5
  • Lectures
  • 30
  • Preparation
  • 76,5
  • Project work
  • 55
  • Total
  • 165,0
Credit
2 ECTS
Type of assessment
Written examination, 1.5 hours under invigilation
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 examination, 2 hours under invigilation
See Medicademy homepage
Exam registration requirements
See Medecademy 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
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/topic is selected and properly referenced.

The participant demonstrates that he/she masters to analyze, recapitulate and critically evaluate 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 European regulatory affairs

The participant demonstrates that he/she is mastering to combine central concepts and disciplines within European regulatory affairs in 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 and literature search of which the most relevant to the selected case/topic has been properly referenced

The participant demonstrates ability to analyze, recapitulate and partly evaluate 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 European regulatory affairs

The participant demonstrates that he/she is mastering central concepts and disciplines within European 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 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 participant demonstrates ability to understand, report and occasionally evaluate relevant law frames and literature for the selected case/topic

The participant demonstrates knowledge to apply terms and law frames within the field of European regulatory affairs

The participant demonstrates that he/she understands central concepts and disciplines within European 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.