Entry requirements

180 credits in medicine/pharmacy

Learning outcomes

This course aims to provide students with a broad and deep knowledge of most stages in a drug's development from idea to completed product. Special emphasis is placed on clinical trial methodology, where the students will learn to plan a larger clinical trial.

At the end of the course the students should:

- Be able to describe the basic principles of pharmacokinetics (PK) and the most common types of PK studies as well as be able to do calculations using pharmacokinetic formulas

- Be able to describe clinical trial methodology according to Good Clinical Practice (GCP)

- Be able to describe the basic principles of biostatistics in clinical trials and do sample size calculations

- Be familiar with the regulatory procedures for the registration of new drugs and the other roles of Regulatory

Affairs in clinical drug development

- Be able to describe the purpose of clinical trial monitoring and be able to perform the monitoring of a clinical trial

- Be able to write a complete clinical trial protocol

Content

The course consists of the following sections:

Introduction and ethics in clinical trials

Pharmacokinetics, PK/PD

Pre-clinical drug development and toxicology

Basic statistics for clinical trials

Trial methodology with applied biostatistics

Registration of new drugs - Regulatory affairs

Clinical trials in various diagnostic areas

Monitoring

Protocol writing

Instruction

The course is given as a series of lectures and seminars, but also consists of study visits, individual projects, and group assignments.

Assessment

Examinations are arranged continuously as seminars or written examinations.

At the final exam, the students will write a complete clinical trial protocol and present it before a smaller group of students as well as examiners in a respondent/opponent form

Students who have not passed the examination have the right to take the examination 4 additional times (= total of 5 examinations). If the student can claim special reasons, additional examinations may be allowed. Every time the student actually sits for an examination will be counted as an examination. Submission of so-called blank examination is counted as an examination.

If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the University's disability coordinator.