SMPMA3191U Product Life Cycle Activities

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

The first study element consists of the Medicademy module “Product Life Cycle Activities”. The key topics are:

- Introduction to Product Life Cycle
- Regulations having impact on Product Life Cycle Activities
- Type IA & IB variations
- Type II variation
- Differences in regulation USA/Japan/world wide from an EU point of view
- New indications/formulations/dosage
- Regulatory Compliance.

For further information please visit the Medicademy homepage

The second study element is offered by Faculty of Health and Medical Sciences in which a case is defined within the topic of Product Life Cycle Activities. 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 the relevant law frame literature and guidelines to product life cycle i.e. related to the case as well as presentation of of the case
- Discussion of relevant law frame, guidelines and literature to product life cycle i.e. related to the case
- Conclusions and future perspectives
- Literature list

Learning Outcome
The course provides comprehensive knowledge of the basis for evaluating the possibilities and consequences of different types of Life Cycle activities and subsequently to plan and perform the activities related to the regulatory maintenance of the product.

On completion of the entire course the participants should understand how to make plans and take decisions with regard to regulatory impact on Product Life Cycle Activities.
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 Medicademy module “Product Life Cycle Activities” 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

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 Product Life Cycle Activities. The case should be described and discussed within the written project report.

In order to initiate the study element participants must have passed the Medicademy module.
  • Category
  • Hours
  • Exam
  • 4
  • Lectures
  • 22
  • Preparation
  • 56
  • Project work
  • 55
  • Total
  • 137
Credit
3 ECTS
Type of assessment
Written examination, 4 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 topic

The participant demonstrates correct application of terms and law frames within the field of product life cycle

The participant demonstrates that he/she is mastering to combine central concepts and disciplines within product life cycle in his/her 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 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 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 product life cycle

The participant demonstrates that he/she is mastering central concepts and disciplines within product life cycle 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 02

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

The participant demonstrates knowledge to apply terms and law frames within the field of product life cycle

The participant demonstrates that he/she understands central concepts and disciplines within product life cycle of relevance to the selected 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.