SMRM18005U Clinical Development and Documentation
This course is offered in collaboration between University of Copenhagen and Atrium as an obligatory part of the Master of Medicines Regulatory Affairs.
See course calendar for course dates
This course is compulsory at both the 2016-curriculum and the 2018-curriculum.
The course is also open for single course student.
The student will obtain knowledge, skills and competencies within the fields of clinical documentation needed to support global marketing authorisations. This includes:
Good Clinical Practice (GCP)
Clinical documentation to be created through all phases of clinical development, from first studies in humans, exploratory studies, confirmatory studies and post marketing studies.
Clinical study protocols, reporting study results, benefit-risk assessment, summaries of clinical data and product information (labelling of drugs), which makes up the clinical documentation submitted to health authorities for approval.
Clinical regulatory strategy and interaction with health authorities to discuss the clinical development as part of the regulatory process to ensure a successful drug development.
The design of early studies, will discuss design of pharmacokinetic and pharmacodynamics studies. The course will discuss how early studies are conducted to best support the design of the confirmatory studies (i.e. phase III trials). The global nature of medicinal product development will be explained and used in model workshops.
Selection of the parameters to be investigated in clinical trials are an important part of drug development, and must be based on the objective of the trials. When these items are in place, the design can be outlined and analytical methodologies described.
Insight into statistical methodologies and different models for clinical trial design.
Clinical Advance Therapy Medicinal Products.
Clinical outcome measures.
Upon completion the student will be able to provide regulatory input to clinical teams. The student will have an overall understanding of what clinical development consist of, and thereby contribute to clinical study teams, investigate the requirements for getting the studies authorised by authorities, interact with global regulators and eventually put together the clinical sections of a marketing authorisation application, create product information and vary the documentation during the lifecycle of the medicinal product.
After completing the course the student is expected to be able to:
Knowledge
- Explain and identify the principles of clinical development from phase I to IV for both small molecules and biopharmaceuticals
- Define the required clinical documentation needed to fulfill regulatory requirement for various situations
Skills
- Create, analyse and evaluate a regulatory strategy plan for the clinical development of a new medicinal product
- Evaluate the possibilities and consequences of the clinical development plan on the desired product information
- Contribute to plans and proposals with regard to clinical development and documentation
- Outline and discuss how benefit-risk balance can be handles during development, the the marketing authorisation application and monitored in the post-marketing period
Competencies
Make decisions with regard to clinical development and documentation necessary for marketing authorisation
Review and assess global clinical data and documentation at all levels of the drug development and life cycle reflecting clinical regulators mindset
Integrate clinical aspects to ensure that the clinical statements in the product information are sufficiently justified
The syllabus comprises selected EU, USA and ICH legislation and guidelines. A list of reading material will be distributed electronically approx. 4 weeks before the course. The course participants are expected to study parts of with the syllabus, corresponding to approximately 800 pages.
• A bachelor's degree or a master’s degree in health and medical sciences, natural sciences, applied sciences or equivalent
• At least 2 years work experience in the pharmaceutical industry, in a medicines agency or in another relevant organization or company
• Proficiency in English
Assignments
Self-study of course literature
- Category
- Hours
- Lectures
- 36
- Preparation
- 47
- Theory exercises
- 4
- Exam Preparation
- 19
- Exam
- 4
- Total
- 110
See course calendar for course dates
Application deadline is 4 weeks before the first day of instruction. If we have empty seats after the application deadline, it is possible to apply after deadline.
- Credit
- 4 ECTS
- Type of assessment
- Written assignment, 4 hours
- Type of assessment details
- The examination is held on Digital Exam - the online platform
for examination at the University of Copenhagen. The examination
consist of:
- Descriptive questions
- Essay - Aid
- All aids allowed
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
- Exam period
Announced in the MRA exam schedule on mra.ku.dk
- Re-exam
Announced in the MRA exam schedule on mra.ku.dk
Criteria for exam assesment
To achieve the grade passed, the student shall (in an adequate level) be able to:
Knowledge
- Explain and identify the principles of clinical development from phase I to IV for both small molecules and biopharmaceuticals
- Define the required clinical documentation needed to fulfill regulatory requirement for various situations
Skills
- Create, analyse and evaluate a regulatory strategy plan for the clinical development of a new medicinal product
- Evaluate the possibilities and consequences of the clinical development plan on the desired product information
- Outline and discuss how benefit-risk balance can be handles during development, the the marketing authorisation application and monitored in the post-marketing period
Competencies
Make decisions with regard to clinical development and documentation necessary for marketing authorisation
Integrate clinical aspects to ensure that the clinical statements in the product information are sufficiently justified
Course information
- Language
- English
- Course code
- SMRM18005U
- Credit
- 4 ECTS
- Level
- Part Time Master
- Duration
- 4 days
- Placement
- Spring And Autumn
- Schedule
- 4 days full time
- Course capacity
- 30
Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Dorte Bjørn-Larsen (19-667174766730646c716774702f6e63747567704275777066306d7730666d)
- Christina Balslev Rindshøj (19-656a746b75766b706330746b7066756a71676c4275777066306d7730666d)
Lecturers
Course responsible:
Dorte Bjørn Larsen, Senior Regulatory Affairs Manager, Regulatory
Policies, Novo Nordisk A/S, Denmark
Christina Rindshøj, Senior Director, Leadership and Regulatory
Expert, Ozack ApS