SMIMB1011U Discovery and Development of Medicines
Master's Programme in Industrial Drug Development - compulsory
See course calendar for course dates on the webpage
for Master of Industrial Drug
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
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).
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
- Pharmaceutical formulation
- Clinical trials
- Regulatory affairs
- Quality assurance
- Production and marketing
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:
- 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
- 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
- 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 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
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.
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
- Theory exercises
Application deadline is 8 weeks before the first day of instruction.
- 5 ECTS
- Type of assessment
- Written examination, 2 hours under invigilationExamination 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 %
- Written aids allowed
The standard programs and IT tools listed under The Faculty of Health and Medical Sciences at KUnet is allowed.
You are not allowed to bring your own calculator, but Excel and windows calculator is available as standard programs. Students will at this exam have access to use Digital Notes (It is allowed to upload notes for the ITX exam via digital exam. You will find a link to this feature from your exam in Digital Exam).
- Marking scale
- 7-point grading scale
- Censorship form
- External censorship
- Exam period
To be announced at the MIND programme's webpage
To be announced at the MIND programme's webpage
Criteria for exam assesment
The examination will monitor the knowledge and skills of the participants using the following criteria:
- 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
- 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