SMRMIF006U  Course in Quality – Active Substance and Medicinal Product

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

This course provides the students with a comprehensive overview of the quality related requirements and critical issues of the quality part of a registration dossier of a medicinal product with interfaces to product development and post approval maintenance. The various subjects range from chemical synthesis of active substances and development of medicinal products including QbD to global quality trends.
After completion of this course the student should be able to understand the basic principles of how to design, develop and document active substances and medicinal products i.e. how data are generated and how the work is regulated by guidelines and quality standards. Additionally, the student should be capable of analyzing and evaluating the development processes, reports, specifications, methods and data – all seen from a regulatory point of view.

This course is connected to the exam SMRMIF006E Exam in Quality - Active Substance and Medicinal Product. To earn the full 4 ECTS credits, you are required to pass the exam.

Learning Outcome

Knowledge

  • Explain and discuss regulatory quality requirements and documentation in regards to medicinal product development.

  • Explain and identify the basic principles of regulatory quality requirements and documentation and how this work is regulated through guidelines and standards.

  • Explain and discuss how quality build into daily activities may improve performance and may result in faster submissions and approval

 

Skills

  • Apply and analyse the development processes, reports, specifications, methods and data to ensure coherency and transparency of the quality dossier and compliance with required guidelines and quality standards
  • Act in the chemistry, manufacturing and control (CMC) interface
  • Analyse and discuss the CMC documentation in relation to the clinical phases

 

Competencies

  • Make quality plans and take decisions with regard to pharmaceutical development

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 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, workshops and self-study of course literature
This course is connected to the exam SMRMIF003E SMRMIF006E Exam in Quality – Active Substance and Medicinal Product. 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 SMRMIF006E Exam in Quality – Active Substance and Medicinal Product.
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 regulatory quality documentation in regards to medicinal product development

  • Explain and identify the basic principles of regulatory quality documentation and how this work is regulated through guidelines and standards

  • Explain and discuss how quality build into daily activities may improve performance and may result in faster submissions and approvals

 

Skills

  • Apply and analyse development processes, reports, specifications, methods and data to ensure coherency and transparency of the quality dossier and compliance with required guidelines and quality standards

  • Analyse and discuss the CMC documentation in relation to the clinical phases

 

Competences

  • Prepare quality plans and describe decision steps with regard to pharmaceutical development and documentation

  • Category
  • Hours
  • Preparation
  • 56
  • Lectures
  • 22
  • Theory exercises
  • 4
  • Total
  • 82