Program Overview

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Program Overview

The Master's Programme in Industrial Drug Development is a comprehensive program that covers various aspects of drug development, including clinical pharmacology and biostatistics.

Program Details

Course Description

The course SMIMB1151U Clinical Pharmacology and Biostatistics is a compulsory course for Master of Industrial Drug Development (MIND) students and is also open to other part-time master's students at the Faculty of Health and Medical Sciences. The course covers the transition process of drug candidates from the preclinical stage to clinical evaluation, with a focus on clinical trial designs, PK/PD methodology, selection of special patient populations, and regulatory requirements.

Learning Outcomes

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

• Outline comprehensively the clinical pharmacological considerations made during drug development
• Explain comprehensively the transition process from nonclinical studies to human clinic
• Demonstrate knowledge of basic clinical pharmacology as prerequisites for planning a clinical trial
• Give an account of pros and cons for available trial designs
• Demonstrate knowledge of pharmacometrics to optimise trial design
• Define the biostatistical concepts for a clinical trial
• Give an account for the value and limitation of use of surrogate endpoints
• Describe the regulatory requirements for conducting a clinical trial

Admission Criteria

Applicants must meet the following criteria:

• A bachelor's degree, a professional bachelor’s degree, a diploma degree, a master’s degree or equivalent within chemistry, biochemistry, pharmacy, medicine, biomedicine, human biology, molecular biology, veterinary sciences, health sciences, nursing, engineering or equivalent
• At least two years of relevant work experience related to development of medicines
• Proficiency in English

Recommended Academic Qualifications

It is recommendable to have completed the MIND course Pharmacology before taking this course.

Teaching and Learning Methods

The course will be taught through lectures, tutorials, and group discussions.

Workload

The workload for the course is as follows:

• Lectures: 30 hours
• Preparation: 59 hours
• Theory exercises: 20 hours
• Project work: 30 hours
• Exam: 1 hour
• Total: 140 hours

Assessment

The assessment for the course will be based on three elements: the protocol as a whole, the student’s individual contribution to the protocol, and the individual assignment.

Exam Details

The exam will be a written assignment, and the assessment will be based on the knowledge, skills, and competence criteria specified.

Course Information

• Language: English
• Course code: SMIMB1151U
• Credit: 5 ECTS
• Level: Part Time Master
• Duration: 5 + 5 days
• Placement: Autumn
• Schedule: See course calendar
• Course capacity: 24 participants

Price

Fees are published on the course webpage, and the fee includes course materials and lunch/coffee.

Study Board

The study board for the program is the Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science.

Contracting Department

The contracting department for the program is the Department of Drug Design and Pharmacology.

Contracting Faculty

The contracting faculty for the program is the Faculty of Health and Medical Sciences.

Course Coordinators

The course coordinators for the program are Morten Andersen.

Lecturers

The list of lecturers may be subject to change, but currently includes Maurizio Sessa and Trine Meldgaard Lund.