Master of Pharmaceutical Regulatory Affairs (MPRA) Programme Regulations 2011

The programme regulations have been established in accordance with the agreement between the Faculty of Pharmaceutical Sciences of the University of Copenhagen (FARMA) and Medicademy regarding the Master of Pharmaceutical Regulatory Affairs programme.

1. Programme designation

The title conferred on graduates of the programme is Master of Pharmaceutical Regulatory Affairs, abbreviated MPRA. The Danish title is Master i Lægemiddelregistrering.

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

The field of Pharmaceutical Regulatory Affairs plays a pivotal function in patient safety and protection. The role of a pharmaceutical regulatory affairs professional is critical for developing new drugs as quickly and effectively as possible, as well as for establishing risk/benefit relationships and ensuring safe and effective patient treatment. Thus, the Pharmaceutical Regulatory Affairs professional has multiple influences on economy aspects of the society.

This programme is an international master’s programme concerning the registration of drugs and biological and biotechnological products and aimed at employees in the pharmaceutical sector.

The programme targets individuals involved in the regulatory and legislative areas of the pharmaceutical industry, as well as employees in healthcare and biotech companies or in regulatory bodies. Programme participants will gain a comprehensive and detailed knowledge of the procedures related to the application, registration and approval of drugs and biological and biotechnological products that will qualify them to specialize in the entire process of drug registration from the initial stages of discovery to final approval. Programme participants will thus be qualified to advise and involve professional groups in the development process surrounding the regulatory and statutory requirements governing drug registration, potentially shortening the length of time it takes for companies to obtain a marketing approval and managing the drug on the international market. 

2.1. Learning outcomes
The Master of Pharmaceutical Regulatory Affairs (MPRA) programme equips graduates with the following knowledge, skills and competences:

Knowledge
MPRA graduates have demonstrated knowledge and understanding of the following:

• The principles of drug discovery and drug development
• EU regulation and legislation
• EU regulatory procedures
• Marketing authorisation applications
• Pharmaceutical regulatory affairs aspects of Pharmaceutical quality
• Pharmaceutical regulatory affairs aspects of Non-clinical development
• Pharmaceutical regulatory affairs aspects of Clinical development
• Pharmaceutical regulatory affairs aspects of Quality management
• The  future directions in global pharmaceutical and health economics and their implications for product development and evaluation

Skills
MPRA graduates are able to:

• Choose the most appropriate marketing authorization application (MAA) procedure for a given medicinal product
• Adhere to European legislation and regulation guidelines
• Identify when consultation (e.g. scientific advice) with the regulatory authorities is needed
• Integrate the interface between chemistry, manufacturing and control (CMC), pharmaceutical development and non-clinical and clinical data
• Participate in product information development
• Perform an adequate audit- and inspection follow-up
• Perform ongoing risk/benefit assessment throughout the lifecycle of a medicinal product

Competencies
MPRA graduates are able to:

• Independently initiate and carry out proper actions between regulatory authorities and the marketing application authorization applicant/holder.
• Critically examine and evaluate scientific data and conclusions intended for regulatory review
• Enable application of new methods, tools and strategies to aid successful drug development and regulatory review
• Enable improvement of the regulatory environment by implementing and upholding good regulatory practices
• Enable regulatory compliance in pharmacovigilance
• Train leaders and employees in regulatory aspects of drug development
• Take independent responsibility for own professional development

3. Admission requirements

Applicants for the MPRA 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 within regulatory affairs or equivalent
• 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.

If 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 Danish-speaking students and faculty are present only. 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 MPRA 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 (40 ECTS credits):
The compulsory survey course ‘Discovery and Development of Medicines’ (5 ECTS credits) is offered by the Faculty of Pharmaceutical Sciences. The other compulsory modules in the MPRA programme are offered by Medicademy and must be completed in combination with an individual written report (2 ECTS credits) undertaken with the guidance of a supervisor from the Faculty of Pharmaceutical Sciences.

All Medicademy courses conclude with a written examination assessed by the subject teacher. Before enrolling for the individual written report, the student must have passed the relevant examinations at Medicademy.

• Discovery and Development of Medicines (5 ECTS credits). External examiner
• Regulatory Affairs in the EU (6 ECTS credits). External examiner
• The Pharmaceutical Law Frames in the EU
• EU Applications for Marketing Authorizations, Paediatric Investigation Plans, Clinical Trials, and Orphan Drug Designation
• Quality – Drug Substance and Drug Product (4 ECTS credits). Examination by subject teacher without an external examiner
• Product Life Cycle Activities (5 ECTS credits). Examination by subject teacher without an external examiner
• Non-Clinical Documentation (5 ECTS credits). Examination by subject teacher without an external examiner
• Regulatory Strategic Considerations during Global Drug Development (4 ECTS credits). Examination by subject teacher without an external examiner
• Clinical Development and Documentation (6 ECTS credits). Examination by subject teacher without an external examiner
• Role and Responsibilities of a Regulatory Affairs Professional (5 ECTS credits). Examination by subject teacher without an external examiner

The student will plan the sequence and pace of the courses taken. However, students are recommended to start with the survey course “Discovery and Development of Medicines”, followed by the “Regulatory Affairs in the EU” course.

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 MPRA programme elements (credit transfer).

6.2. Elective programme elements (0-8 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. Elective programme elements must be approved by the Study Board.

The elective part of the programme may also be used for expansion of the master’s project.

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 MPRA programme within the framework of the relevant executive orders and the following rules and regulations:

• Examination rules for degree programmes and courses at The Faculty of Pharmaceutical Sciences
• Rules for the elective part of the MPRA programme
• 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 MPRA 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 and individual supervision 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 selected compulsory courses (Discovery and Development of Medicines and Regulatory Affairs in the EU) are assessed by an external examiner (in total a minimum of 23 ECTS-credits). The assessment method is stated in the course description for each course.

The programme is 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 April 2011 and apply to students commencing study on 1 April 2011 or later. The Study Board for part-time master’s programmes will specify interim provisions in regards to students enrolled prior to 1 April 2011 who have not yet passed all compulsory courses laid down in the 2007 Programme Regulations. The students already enrolled under the previous programme will be offered to be transferred to these regulations. The individual implications of the interim provisions will be announced to each student in writing.

Professor Harald S. Hansen
Chairman of the Study Board for part-time master’s programmes

Professor Sven Frøkjær
Dean at the Faculty of Pharmaceutical Sciences, University of Copenhagen