SMPMA3161U Quality - Drug Substance and Drug Product

Volume 2013/2014
Education
Master of Pharmaceutical Regulatory Affairs (MPRA)
Content

The first study element consists of the Medicademy module “Quality - Drug Substance and Drug Product”. The key topics are:

- Quality requirement in drug development
- Quality related to drug substance (synthesis, characterization, impurities)
- certificate of the European Pharmacopea (CEP) and European Active Substance Master File (ASMF)
- Drug product
- Developing specification (substance, product)
- Stability (substance, product)
- Environmental risk assessment
- Global quality dossier and trends.

For further information please visit the Medicademy homepage

The second study element is offered by the Faculty of Health and Medical Sciences. In which a case is defined within the topic of quality requirement to drug substances. The project report will be supervised by maximal 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 relevant law frame, guidelines and literature in quality of drug substance and drug product related to the case as well as presentation of the case

- Discussion of law frame literature and guidelines in quality of drug substance and drug product related to the case
- Conclusions and future perspectives
- Literature list

Learning Outcome
On completion of the entire course the participants will understand and be able to make quality plans and decisions in 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 must 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 2 study elements:

1) The Medicademy module “Quality - Drug Substance and Drug Product” which includes a three 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 production of an individual project report which is written under the guidance of relevant 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 quality requirements to drug substances and drug products in pharmaceutical drug development. The case should be described and discussed within the written project report.
  • Category
  • Hours
  • Exam
  • 1,5
  • Lectures
  • 22
  • Preparation
  • 31,5
  • Project work
  • 55
  • Total
  • 110,0
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
For further information please visit the 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 and literature search of which the most important and relevant to the case 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

The participant demonstrates correct application of terms and law frames within the field quality of drug substance and drug product

The participant demonstrates that he/she is mastering to combine central concepts and disciplines within quality of drug substance and drug product in his/her analysis of the topic

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

The participant demonstrates fairly correct application of terms and law frames within the field of quality of drug substance and drug product

The participant demonstrates that he/she is mastering central concepts and disciplines within quality of drug substance and drug product and has the ability to relate those to the selected case

The participant has written a coherent project report in which the various subtopics of the case 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 quality of drug substance and drug product

The participant demonstrates that he/she understands central concepts and disciplines within quality of drug substance and drug product of relevance to the selected case.

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