Discovery and Development of Medicines
Course content
The topics taught are:
- Target evaluation and biopharmaceuticals
- Identification of lead structures
- Medicinal chemistry: Lead optimization and synthesis
- Non-clinical safety
- Animal biology and pharmacology
- Preformulation
- Pharmaceutical formulation
- Clinical trials
- Quality assurance
- Regulatory affairs
- Production
- Marketing
Master's Programme in Industrial Drug Development - compulsory
See course calendar for course dates on the webpage
for Master of Industrial Drug
Development
Compulsory for Master of Industrial
Drug Development (MIND) students and
Master of Medicines Regulatory Affairs
(MRA) 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).
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
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.
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.
Applicants must meet the following criteria:
• A bachelor's degree or a master’s degree in health and
medical sciences, natural sciences, applied sciences or equivalent
• At least 2 years work experience in the pharmaceutical industry,
in a medicines agency or in another relevant organization or
company
• Proficiency in English
Application deadline is 8 weeks before the first day of instruction.
Apply directly on the programme's webpage
- ECTS
- 5 ECTS
- Type of assessment
-
Written examination, 2 hours under invigilation
- Type of assessment details
- 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
Find more information about written on-site exams in the exam rooms, incl. information about standard programs on the exam PCs at KUnet - Study Information - Exam types and rules - Written on-site exam (ITX).
- Marking scale
- 7-point grading scale
- 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
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
Part time Master and Diploma courses
- Category
- Hours
- Lectures
- 40
- Preparation
- 78
- Theory exercises
- 20
- Exam
- 2
- English
- 140
Kursusinformation
- Language
- English
- Course number
- SMIMB1011U
- ECTS
- 5 ECTS
- Programme level
- Part Time Master
Full Degree Master
- Duration
-
5 + 5 days
- Placement
- Autumn And Spring
- Price
-
Fees are published on the programme's homepage at https://mind.ku.dk/tuition/ Fee includes course materials and lunch/coffee. Prices may be subject to change.
Textbook must be purchased by the participants.
- Schedulegroup
-
see course calendar
- Capacity
- 36 participants
- Studyboard
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Drug Design and Pharmacology
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinator
- Anders Bach (11-657268697677326665676c4477797268326f7932686f)
Teacher
This list of lecturers may be subject to change.
Søren Østergaard
Mads Grønborg
Julie Kaae Klint
Søren Møller Nielsen
Anette Graven Sams
Dorte Kold Jensen
Anders Lohse
Per Rexen
Morten Dahl Sørensen
Helle Northeved
Klaus Gjervig Jensen
Frank Larsen
Jesper F Bastlund
Benjamin Hall
Heidi Lopez de Diego
Jette Bisgaard Boll
Lars Hovgaard
Erik Skibssted
Petteri Heljo
Tue Hansen
Louise Bastholm Jensen
Anette Torstenson
Karina Nymark
Sidse Schjøtz
Stine Kihl-Plambek
Christian Bressen Pipper
Gitte Dyhr
Dorte Bjørn-Larsen
Anette Hjelmsmark
Troels V. Christensen
Anders Krabbe
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