SMRMIF003U  Course in Clinical Development – Efficacy of Medicines

Volume 2017/2018
Education

This course is offered in collaboration between University of Copenhagen and Medicademy as part of the Master of Medicines Regulatory Affairs. It is possible to follow the course as a single course student.

Content

The student will obtain knowledge within the fields of clinical documentation needed to support global marketing authorisations. This includes:

  • Understanding Good Clinical Practice (GCP)

  • 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.

  • 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.

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 lifecycle of the medicinal product.

This course is connected to the exam SMRMIF003E Exam in Clinical Development – Efficacy of Medicines. To earn the full 4 ECTS credits, you are required to pass the exam.

Learning Outcome

After completing the course the student is expected to be able to:

Knowledge

  • Explain and discuss the required clinical documentation for a marketing authorisation application (MAA)
  • Explain and identify the principles of clinical development from phase I to IV for both small molecules and biopharmaceuticals
  • Explain and discuss how clinical risk assessment can be handled during development

 

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

 

Competencies

  • Contribute to plans and proposals with regard to clinical development and documentation

The syllabus comprises selected CHMP/ICH guidelines and EC directives and regulations. 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.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years working experience within regulatory affairs
• Proficiency in English
Lectures and class instructions
Assignments
Self-study of course literature
This course is connected to the exam SMRMIF003E Exam in Clinical Development – Efficacy of Medicines. Exam registration is highly recommeded, and to earn the full ECTS credits of the course, you are required to pass the exam.
Credit
3 ECTS
Type of assessment
Course participation
Participation in the course is a requirement for participating in the exam: SMRMIF003E Exam in Clinical Development – Efficacy of Medicines
Aid

 

 

Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment

To achieve the grade passed, the student shall (in an adequate level) be able to:

Knowledge

  • Explain and discuss the required clinical documentation for a marketing authorisation application (MAA)
  • Explain and identify the principles of clinical development from phase I to IV for both small molecules and biopharmaceuticals
  • Explain and discuss how clinical risk assessment can be handled during development

 

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

 

Competencies

  • Contribute to plans and proposals with regard to clinical development and documentation
  • Category
  • Hours
  • Preparation
  • 47
  • Lectures
  • 36
  • Theory exercises
  • 4
  • Total
  • 87