Kursussøgning, efter- og videreuddannelse – Københavns Universitet

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Kursussøgning, efter- og videreuddannelse

Drug Regulatory Affairs - from Drug Discovery to Approval and Marketing

Practical information
Study year 2016/2017
Time
Block 4
Programme level Full Degree Master
Full Degree Master choice
ECTS 7,5 ECTS
Course responsible
  • Christine Erikstrup Hallgreen (19-6b707a717b7c71766d36706974746f7a6d6d76487b7d766c36737d366c73)
  • Department of Pharmacy
Course number: SFKKA9091U

Course content

Lectures will cover the following subjects:

  • An overview of the drug development process from drug discovery to development and pharmacovigilance
  • Patenting
  • Career options for a regulatory affairs professional
  • Overview of regulatory agencies and procedures in Europe
  • Special regulatory pathways
  • Requirements for a regulatory application
  • Analytical, pharmaceutical, toxicological and clinical documentation
  • Bioavailability and bioequivalence
  • Biotechnology products/Biologics
  • Regulatory affairs in pharmacovigilance
  • Marketing
  • Health technology assessment

 

Synopsis and presentation:
The synopsis and presentations will be based on drafting a regulatory plan

Learning outcome

Objective

The process of discovering, developing, and bringing a new drug to market under the regulatory framework is complex and highly cross-disciplinary. In the first part of the course, the aim is to provide the students with an overview of the different phases and various scientific disciplines involved in drug discovery and development, viewed from the regulatory affairs perspective. The regulatory affairs expert plays an essential role in developing and trialling new medicines, and on placing and monitoring them on the market. The second part of the course will aim to give more detailed insight into the legal framework, the considerations and practicalities, and the scientific background involved in the regulatory process.

At the end of the course, students will be able to:

Knowledge

  • understand drug registration within the EU, including the political and legal framework, EMA and ICH guidelines, application procedures and documentation with focus on pharmaceutical-chemical documentation.
  • describe the different phases of the drug development process in the pharmaceutical industry, and how drug regulatory affairs plays a role in each phase.

Recommended prerequisites

It is an advantage to have knowledge within pharmaceutical sciences or drug registration, or of subjects related to the pharmaceutical drug development process. For example, knowledge regarding clinical trials, toxicology, bioavailability studies, or pharmaceutical formulation or pre-formulation.

Mandatory prerequisites

None.

Sign up

Open for Danish and international guest students. For application details look here: http://sund.ku.dk/uddannelse/andre-uddannelsestilbud/meritstuderende/

Education

MSc in Pharmaceutical Sciences - elective

MSc in Medicinal Chemistry - elective

Cand.Scient.Pharm. - elective

Cand.Pharm. - elective

Studyboard

Study Board of Pharmaceutical Sciences

Duration

1 block

Schedulegroup

C
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Teaching and learning methods

• Lectures: 30 hours
• Workshops (with lecture present): 16 hours
• Oral presentation and opponent: 6 hours

Capacity

24 students

Language

English

Literature

Handouts and guidelines available at the course homepage and material need to prepare the regulatory plan.

Workload

Category Hours
Lectures 30
Preparation 90
Colloquia 4
Project work 66
Guidance 16
English 206

Exam (SFKKA9091E - continuous assessment)

Type of assessment

Course participation
The continuous assessment is done on the basis of the course participation, including that the student:

• has participated in 80% of the lectures
• has written a synopsis which is then approved by the lecturer
• has participated satisfactorily in preparing a regulatory plan
• has participated satisfactorily in a group's presentation and in a discussion of the regulatory plan
• has fulfilled the role of opponent to another group's presentation to satisfaction.

A Course certificate is obtained on the basis of the student’s course participation and performance on presentation day.
On presentation day the student will perform a presentation based on the regulatory plan described in the synopsis.
On the presentation day there will be a regulatory expert panel present. The panel will participate in the discussion of the presented regulatory plan with the students. The students ability to discuss regulatory matters with the experts will be part of the assessment.

Marking scale

passed/not passed

Criteria for exam assessment

To obtain a course ceritficate, students should be able to:

Knowledge

  • understand drug registration within the EU, including the political and legal framework, EMA and ICH guidelines, application procedures and documentation with focus on pharmaceutical-chemical documentation.
  • describe the different phases of the drug development process in the pharmaceutical industry, and how drug regulatory affairs plays a role in each phase.

Censorship form

No external censorship
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