Master of Industrial Drug Development (MIND) Programme Regulations 2010

The programme regulations have been established in accordance with Executive Order no. 1187 of 7 December 2009 on Master’s Programmes at Universities and Executive Order no. 1188 of 7 December 2009 on Part-time Programmes issued by the Ministry of Science, Technology and Innovation.

1. Programme designation

The title conferred on graduates of the programme is Master of Industrial Drug Development, abbreviated MIND. The Danish title is Master i industriel lægemiddeludvikling.

The programme falls within the scope of the Study Board for part-time master’s programmes at the Faculty of Pharmaceutical Sciences, University of Copenhagen.

2. Purpose of the programme

Drug development is a long, complex process requiring the interaction of numerous specialist fields. Growing competition in the industry has increased the need to coordinate the many elements involved in order to accelerate the drug development process and smooth the transition of candidate drugs to market. Skilful coordination of all the disciplines involved, from early target identification and validation through safety and efficacy testing to market launch, can streamline the approach to the production of new medicines.

The overall purpose of the MIND programme is to provide the biotech and pharmaceutical industries, pre- and clinical research organisations, medical device industry and related enterprises with academic personnel who have insight into and understanding of all aspects of the industrial drug development process, and who are qualified to lead multidisciplinary teams across divisional lines to respond to the challenges of the industry.

2.1. Learning outcomes

The Master of Industrial Drug Development (MIND) programme equips graduates with the following knowledge, skills and competences:

Knowledge

MIND graduates have demonstrated knowledge and understanding of the following subjects:

• target identification and validation methods and processes
• lead optimisation methods and processes
• principal steps and methodologies in drug discovery and development including translational steps
• principal steps in discovering, modifying, assessing, producing and patenting new chemical and biological compounds
• the overall development plan involving medicinal chemical, pharmaceutical, non-clinical and clinical development
• quality assurance
• regulation of medicines in the EU
• management of drug safety issues before and after market authorisation
• management of lifecycle activities (regulatory and marketing) of a medicine
• ethical and legal provisions in drug development

MIND graduates have in-depth knowledge based on the highest level of international research in one or more subject areas in a selected field.  On this scientific basis, graduates are equipped to understand and reflect on the knowledge of the other subject areas and identify scientific issues.

Skills

MIND graduates are able to:

• apply basic computational methods in the areas of bioinformatics and structure-based drug design
• adhere to GMP and GCP guidelines for drug products
• apply knowledge of drug regulatory affairs to work tasks and project strategies
• schedule and integrate non-clinical tests into overall drug development and assess their predictive value
• perform early studies in patients: dose-finding and proof-of-concept studies
• design a confirmatory clinical development plan
• perform a benefit/risk assessment throughout the lifecycle management of a medicine

Competencies

MIND graduates are able to:

• effectively and critically evaluate each stage of the drug development process and predict future bottlenecks
• critically evaluate validation  of drug targets
• manage and develop complex work situations related to drug discovery and development
• critically evaluate chemical process development projects
• independently initiate and carry out discipline-specific and interdisciplinary collaboration related to drug development
• initiate, plan, implement and assume professional responsibility for drug development projects from discovery to clinical trials and registration
• organise the elements of a drug development programme
• liaise and communicate professionally, using scientific terminology, with other specialist groups within the drug development industry
• take independent responsibility for own professional development.

3. Admission requirements

Applicants for the MIND programme must meet the following criteria:

• hold a relevant bachelor’s degree, professional bachelor’s degree, diploma degree or equivalent. Relevant disciplines would be chemistry, biochemistry, pharmacy, medicines, biomedicines, human biology, molecular biology, veterinary sciences, health sciences, nursing and engineering.
• have at least two years of relevant work experience related to drug development
• be proficient in English

The Study Board may require documentation of adequate English skills.

Persons who do not meet the educational admission requirements but have otherwise earned equivalent qualifications may also apply for admission. The Study Board will assess all applicants on the basis of their overall qualifications.

The courses offered under the master's programme can be taken as single courses. The same admission requirements apply to students taking single courses. If the number of applicants for a given course exceeds the number of places, priority will be accorded to students enrolled in the full master's programme.

It the Study Board has doubts about the adequacy of an applicant’s qualifications, the applicant may be granted access to the programme conditional on passing one or two compulsory courses. 

4. Language of instruction

Teaching is conducted in English, unless only Danish-speaking students and faculty are present. The Study Board may dismiss students whose lack of fluency in English interferes with teaching.

All examinations are held in English.

5. Programme credits and duration

The MIND programme carries 60 ECTS credits (European Credit Transfer System), which is equivalent to one year of full-time study.

The programme is part-time and must be completed within two to six years. 

6. Programme structure and components

The programme consists of compulsory courses, elective courses and a master's project. 

6.1. Compulsory courses (30 ECTS credits):

Survey:      

• Discovery and Development of Medicines (5 ECTS credits)

Discovery:     

• Drug Discovery (3 ECTS credits)

Exploratory development:

• Pharmacology (2.5 ECTS credits)
• Non-clinical Safety and Toxicology (2.5 ECTS credits)

Pharmaceutics:

• Drug Formulation and Delivery (4 ECTS credits)
• Chemical Development and Production of Active Pharmaceutical Ingredients (API) (3 ECTS credits)

Regulatory Affairs:

• Drug Regulatory Affairs in Drug Development (2.5 ECTS credits)

Quality Assurance:

• QA, QC, GXP for Industrial Production (2.5 ECTS credits)

Clinical Pharmacology:

• Clinical Pharmacology and Biostatistics (5 ECTS credits)

It is up to the individual student to determine the sequence and pace of taking the courses. However, students are recommended to start with the survey course ‘Discovery and Development of Medicines’.

Individual course descriptions specify learning outcomes, contents, teaching and learning methods, prerequisites for participation, etc.

The Study Board may approve that passed programme elements from other approved/accredited Danish master’s programmes or corresponding foreign programmes replace compulsory MIND programme elements (credit transfer).

6.2. Elective programme elements (10-18 ECTS credits)

Elective programme elements must be selected from those offered to master's students by the Faculty of Pharmaceutical Sciences or other universities in Denmark or abroad. The supervisor may require that the student takes certain elective courses (up to a maximum of 7.5 ECTS credits). Elective programme elements must be approved by the Study Board.

6.3. Master's project (12-20 ECTS credits)

The master's project is a practice-oriented research project on an elective topic subject to approval by the student's supervisor. The project is written under the guidance of at least one faculty member from the Faculty of Pharmaceutical Sciences (internal supervisor) and preferably a senior employee from the company or institution hosting the master's project (external supervisor).

6.4. Course descriptions and rules

The detailed course descriptions approved by the Study Board for all courses and the master's project include:

• course objectives
• learning outcomes
• general content
• prerequisites for participation
• teaching and learning methods
• examination and assessment
• student workload
• course director and lecturers
• practical information (dates, course structure , course weight, course fee, application deadline, course capacity, language)

The Study Board has set out the following rules and guidelines for the MIND programme within the framework of the relevant executive orders and the following rules and regulations:

• Examinations regulations for programmes at The Faculty of Pharmaceutical Sciences
• Rules for the elective part of the part-time master's programmes
• Joint guidelines for the full-time and part-time master's thesis examination
• Definitions of instructional terms

The Study Board may establish other rules for the MIND programme within the framework of the programme regulations.

7. Prerequisites for establishing courses

In the event that a course attracts fewer than 15 students, the Faculty of Pharmaceutical Sciences reserves the right to cancel the course. However, when accepting applications for the master's programme, the Faculty undertakes to provide single courses enabling master's students to complete the programme within two years after enrolment. The faculty is under no obligation to provide courses over and above the two years.

8.  Examinations

Examinations are governed by the following executive orders and rules:

• Executive Order no. 857 of 1 July 2010 on Examination and Assessment of Exam Performance at University Programmes (the Examination Order)
• Executive Order no. 250 of 15 March 2007 on Grading Scales and other Forms of Assessment
• Examinations regulations for programmes at The Faculty of Pharmaceutical Sciences

The master's project and compulsory courses are assessed by an external examiner. The assessment method is stated in the course description for each course.

The programme is among those served by the college of external examiners appointed for the degree programmes of the Faculty of Pharmaceutical Sciences at the University of Copenhagen.

9.  Exemption

When exceptional circumstances so justify, the Study Board may grant exemption from rules in the programme regulations that have been stipulated solely by the Study Board.

10.  Entry into force

The programme regulations enter into force on 1 September 2010 and apply to students commencing study on 1 September 2010 or later. Previously enrolled students will not be affected by the new programme regulations.

Signed by:

Professor Harald S. Hansen, Chairman of the MIND/MPRA Study Board & Professor Sven Frøkjær, Dean