Kursussøgning, efter- og videreuddannelse – Københavns Universitet

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Kursussøgning, efter- og videreuddannelse

Discovery and Development of Medicines

Practical information
Study year 2016/2017
Time
Autumn
Price

DKK 21,500 (non EU/EEA citizens DKK 25,085). Fee includes course materials and meals. Prices may be subject to change. Textbook must be purchased by the participants.

Programme level Part Time Master
ECTS 5 ECTS
Course responsible
  • Fredrik Björkling (2-69654376787167316e7831676e)
To be announced
  • Department of Drug Design and Pharmacology
Course number: SMIMB1011U

Course content

The topics taught are:

  • Genome and target evaluation
  • Identification of lead structures
  • Medicinal chemistry: Lead optimization and synthesis
  • Non-clinical safety
  • Animal biology and pharmacology
  • Pre-formulation
  • Pharmaceutical formulation
  • Clinical trials
  • Regulatory affairs
  • Quality assurance
  • Production and marketing

Learning outcome

People involved in the development of medicines have diverse educational backgrounds. Often their basic academic educations have not at all touched upon discovery and development of medicines. This course aims to convey knowledge of drug discovery and development in general to the participants so they may communicate across the different fields of the process.

On completion of the course, participants will have comprehensive overview of drug discovery and development and a sound grasp of the fundamentals of the major implicated disciplines. Participants will be able to convey an understanding of the dynamics of the drug discovery and development and communicate across research fields.

Upon completion of the course, participants are expected to be able to:

Knowledge

  • give a comprehensive overview of discovery and development of medicines
  • identify correct professional terms in discovery and development of medicines
  • list major steps and elements of the drug development process
  • outline definitions of key concepts and the fundamentals of the major disciplines in drug discovery and development
  • identify the important transition points that require involvement of authorities


Skills

  • appraise the integration of the various basic disciplines into the process of discovery and development of medicines
  • analyse the sequence and flow of the various steps in the process of drug discovery and development
  • plan a development process within the regulatory framework


Competencies

  • liaise with all steps of drug discovery and development
  • identify critical factors and bottlenecks that influence the drug development process
  • promote and state milestones for the progress of the development of a medical product
  • communicate professionally with the various specialist groups within the industrial area of development of medicines

Mandatory prerequisites

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

Sign up

Deadline 1 September 2016

Apply here 

 

Education

Master's Programme in Industrial Drug Development - compulsory

Compulsory for Master of Industrial Drug Development (MIND) students, Master of Pharmaceutical Regulatory Affairs (MPRA) students, elective for other part-time master's students at the Faculty of Health and Medical Sciences (subject to study board approval) and open for freelance students who meet the admission criteria.

The course is intended for drug development professionals and regulatory affairs professionals who need an overview of the entire drug discovery and development process, or professionals who need a brush-up course for continuing professional development (CPD).

Studyboard

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

Course type

Part time Master and Diploma courses

Teacher

This list of lecturers may be subject to change.

Anette Frost Jensen, H. Lundbeck
Anette Hjelmsmark, Novo Nordisk
Anette Seo Torstenson, H. Lundbeck
Asser Sloth-Andersen, Novo Nordisk
Birgitte Ursø, Novo Nordisk
Birgit Thalsø-Madsen, LEO Pharma
Bo Maach-Møller, Eli Lilly Danmark
Fredrik Björkling, University of Copenhagen
Frank Larsen, H. Lundbeck
Gitte Dyhr, H. Lundbeck
Helle Northeved, H. Lundbeck
Henning G. Kristensen, University of Copenhagen
Henrik Fylking-Nielsen, Novo Nordisk
Jesper Frank Bastlund, H. Lundbeck
Jesper Lau, Novo Nordisk
Jørgen Godt Olsen, Niels Clauson-Kaas
Jørn Møller-Sonnergaard, University of Copenhagen
Karin Liltorp, H. Lundbeck
Karsten Lollike, Novo Nordisk
Karsten Petersson, LEO Pharma
Kim Dekermendjian, H. Lundbeck
Klaus Henning Jensen, Novo Nordisk
Kurt Pfeiffer Petersen, AstraZeneca
Lars Dalgaard, H. Lundbeck
Lazlo Tanko, Ferring Pharmaceuticals
Liselotte Langkjær, Novo Nordisk
Mads Kreilgaard, H. Lundbeck
Mogens Lauritzen, Novo Nordisk
Niels Plath, H. Lundbeck
Nina Bjarnason, Department of Internal Medicine, Roskilde Hospital
Nya Feldthus, Eli Lilly Danmark
Ole J. Bjerrum, University of Copenhagen
Ole K. Eskerud, Novo Nordisk
Per Rexen, Novo Nordisk
Paul Berthelsen, Nycomed Pharma
Pontus Forsell, Astra Zeneca
René Holm, H. Lundbeck
Søren Berg Padkjær, Novo Nordisk
Torben Enstrøm, Novo Nordisk
Troels V. Christensen, H. Lundbeck
Vibeke Bjerregaard, Novo Nordisk

Duration

9-13 January + 24-27 January + 30 January 2017

Schedulegroup

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---- SKEMA LINK ----

Teaching and learning methods

The course is organized as an intensive 10-day course and comprises lectures, group discussions, presentations and discussions. In order to emphasize the flow of the process, the course is to a large extent based on the use of cases in both lectures and assignments.

Capacity

36 participants

Language

English

Literature

The syllabus comprises collections of review papers, textbook chapters and case stories and updated lecture slides, corresponding to approximately 500 pages. All material will be distributed electronically either placed on the course homepage or as an USB. 

Participants are expected to purchase: Drug Discovery and Development. Technology in Transition, 2nd edition Humphrey P. Rang, Churchill Livingstone, 978-0443064203. Avalable also as E-Book.

The Textbook of Pharmaceutical Medicine, 7th edition, 2013. John P. Griffin (Editor), John Posner (Editor), Geoffrey R. Barker (Editor) Blackwell BMJ Books serves as “nice to know” and it is used in other MIND courses.

Workload

Category Hours
Preparation 78
Exam 2
Theory exercises 20
Lectures 40
English 140

Exam (SMIMB1011E)

Type of assessment

Written examination, 2 hours under invigilation
Examination design: The test is composed of essay questions and multiple choice questions.The purpose of the examination is to test that the examinee has achieved the expected learning outcomes. The percentage of items in the test devoted to a particular topic will roughly correspond to the emphasis given the topic in teaching of the course:
• Discovery: 20 %
• Non-clinical (exploratory) development: 50 %
• Clinical development: 30 %

Aid

Written aids allowed

Apart from the standard programs and IT tools listed under The Faculty of Health and Medical Sciences at http://pc-exam.ku.dk/it_tools/health/ students will at this exam also have access to use a USB stick (for notes etc.)

Calculators are not allowed

Marking scale

7-point grading scale

Criteria for exam assessment

The examination will monitor the knowledge and skills of the participants using the following criteria:

Knowledge

  • the ability to give a comprehensive overview of discovery and development of medicines
  • the ability to identify correct professional terms in discovery and development of medicines
  • the capability to list major steps and elements of the drug development process
  • the capability to outline definitions of key concepts and the fundamentals of the major disciplines in drug discovery and development
  • the ability to identify the important transition points that require involvement of authorities


Skills

  • the understanding of the integration of the various basic disciplines into the process of discovery and development of medicines
  • the skill to analyse the sequence and flow of the various steps in the process of drug discovery and development
  • the ability to plan a development process within the regulatory framework

 

 

Censorship form

External censorship

Exam period

To be announced at the MIND programme's webpage 

 

Re-exam

To be announced at the MIND programme's webpage 

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