SMPMA3101U Biopharmaceuticals – Quality Development and Documentation

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

The firststudy element consists of the Medicademy module “Biopharmaceuticals – Quality development and documentation”. The key topics are:

  • Bio/biotech products
  • Cell banks
  • Gene therapy/cell therapy
  • Plasma derived medicinal products
  • Immunological products
  • Non clinical requirements for biotech products
  • Impurities, viral removal and safety evaluation
  • Bioassays and international standards for biologicals
  • Stability
  • Manufacturing process, process control, process validation
  • EU regulatory procedures for Biotech products
  • USA vs EU vs Japan

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 development and approval of bio and biotech products 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 contents
  • Abstract
  • Introduction includes presentation of the case/topic, statement of purpose, as well as description of the relevant bio/biotech law frame, guidelines, literature and data related to the case/topic
  • Discussion includes analysis and balanced discussion of relevant bio/biotech 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 legislation of biological and biotechnological pharmaceutical products.

On completion of the entire course the participants are aimed to be able to understand, apply, analyze, discuss and describe key elements in the legislation of bio/biotech products such as vaccines, monoclonal antibodies, blood derivatives and product used for gene therapy.
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:

The Medicademy module “Biopharmaceuticals – Quality Development and Documentation”. 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 development and approval of bio and biotech products.

In order to initiate the study element participants must have passed the Medicademy module.
  • Category
  • Hours
  • Exam
  • 3
  • Lectures
  • 22
  • Preparation
  • 23
  • Project work
  • 55
  • Total
  • 103
Credit
1,7 ECTS
Type of assessment
Written examination, 3 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, 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 approval of bio and biotech products.

The participant demonstrates that he/she is mastering to combine central concepts and disciplines within development and approval of bio and biotech products 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 approval of bio and biotech products

The participant demonstrates that he/she is mastering central concepts and disciplines within the development and approval of bio and biotech products 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 approval of bio and biotech products

The participant demonstrates that he/she understands central concepts and disciplines within development and approval of bio and biotech products 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