Kursussøgning, efter- og videreuddannelse – Københavns Universitet

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Kursussøgning, efter- og videreuddannelse

Quality - Drug Substance and Drug Product

Practical information
Study year 2016/2017
Time
Autumn , Spring And Summer
Price

The total course fee consists of the following 2 parts:

1) Participation in the Medicademy module. For further information on enrolment, fees and payment details, please visit the Medicademy homepage.

2) Project report at the Faculty of Health and Medical Sciences: master's students DKK 9,500 and freelance students DKK 13,000.

Programme level Part Time Master
ECTS 2 ECTS
Course responsible
  • Sven Frøkjær (13-5e81707939517d7a76756c707d4b7e80796f397680396f76)
  • Department of Pharmacy
Course number: SMPMA3161U

Course 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

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

Knowledge

  • Explain and discuss quality with regards to drug development

  • Explain and identify the basic principles of quality and how this work is regulated through guidelines and standards

Skills

  • Apply and analyse development processes, reports, specifications, methods and data to ensure coherency and transparency of the quality dossier

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

Competencies

  • Make quality plans and take decisions with regard to drug development

Mandatory prerequisites

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.

Sign up

1) “Quality - Drug Substance and Drug Product”. For information about course dates and application deadlines please visit the Medicademy homepage.

2) Applications for the element offered by the Faculty of Health and Medical Sciences are accepted throughout the year.   Apply here

Education

Master of Pharmaceutical Regulatory Affairs (MPRA)

Studyboard

Study Board for Part-time Master’s Programmes of Pharmaceutical Sciences

Course type

Part time Master and Diploma courses

Teacher

For information on lecturers and directors at the Medicademy module “Quality - Drug Substance and Drug Product” please visit the Medicademy homepage.

The project report at the Faculty of Health and Medical Sciences is supervised by supervisors at the Department of Pharmacy, Faculty of Health and Medical Sciences.

Duration

Schedulegroup

Through out the year.
---- SKEMA LINK ----

Teaching and learning methods

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.

Capacity

The Medicademy module “Quality - Drug Substance and Drug Product” has a capacity of approximately 25 participants.

The Faculty of Health and Medical Sciences allows a maximum of 20 students a year to initiate work on the project report covering “Quality - Drug Substance and Drug Product”.

Language

English

Workload

Category Hours
Lectures 22
Project work 55
Exam 1,5
Preparation 31,5
English 110,0

Exam 1 (SMPMA3161E)

Type of assessment

Written examination, 1,5 hours under invigilation
See Medicademy homepage

Marking scale

passed/not passed

Criteria for exam assessment

For further information please visit the Medicademy homepage.

Censorship form

No external censorship

Exam 2 (SMPMA3161E)

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

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 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

Censorship form

No external censorship
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