SMRM18010U  Quality – Drug Substance and Drug Product

Volume 2018/2019
Education

This course is offered in collaboration between University of Copenhagen and Atrium as part of the Master of Medicines Regulatory Affairs.

 

See course calender 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.

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 Quality bu Design (QbD) to global quality trends.
Attendees wil get an understanding of 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.

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.

 

Skills

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

  • make descisions with regard to pharmaceutical development and documentation necessary for optaining a market authorisation

  • review and asses pharmaceutical data and documentation at all levels of the drug development and life cycle reflection a quality mindset

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 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
Oral
Collective
Continuous feedback during the course of the semester
Credit
4 ECTS
Type of assessment
Written assignment, 3 hours
3 hours written assignment with descriptive questions and multiple choice held on Digital Exam - The online platform for examination at the University of Copenhagen.
Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Exam period

Exam schedule is published on http://mra.ku.dk/calender/exams/

Re-exam

Exam schedule is published on http://mra.ku.dk/calender/exams/

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 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.

 

Skills

  • Explain and discuss how quality build into daily activities may improve performance and may result in faster submissions and approval
  • 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 standard
  • Analyse and discuss the CMC documentation in relation to the clinical phases

 

Competencies

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

  • Category
  • Hours
  • Preparation
  • 61
  • Lectures
  • 22
  • Theory exercises
  • 4
  • Exam Preparation
  • 20
  • Exam
  • 3
  • Total
  • 110