Course in Biopharmaceuticals – Quality Development and Documentation

Course content

The aim of this course is to give attendees knowledge about the scientific background of biotechnological products and the regulatory requirements to fulfil, in order to obtain approval of these types of medicinal products.

Attendees will get an understanding of the quality issues specific to biopharmaceuticals, for example; the generation of a recombinant microorganism, the expression of the product from the microorganisms and its purification, and the regulatory expectations for characterisation of a biopharmaceutical product and to release/stability specifications set for these types of products. As process changes are inevitable during development of a biological/biotechnological product this course will provide the implications of changes in the production process and elaborate the concept of comparability.

In addition to providing the students with a general understanding of specific quality issues for biopharmaceuticals, this course will focus on how to prepare regulatory CMC/Quality strategies and how to ensure compliance with regulatory requirements throughout the clinical development and post-approval processes. The discussions on CMC/Quality strategies will include both EU and FDA aspects, and the lectures will focus attention on both EU and FDA regulatory procedures for approval of biopharmaceuticals. Further, the course will guide the students through the structure of CMC/Quality sections for IND/CTA and BLA/MAA in the CTD format.

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.

Learning outcome

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

Knowledge

  • Understand the basic principles of manufacturing biopharmaceuticals - from the recombinant starting material to the final product, including product characterization and setting specifications as well as the specific quality issues of biopharmaceuticals.

  • Understand the critical parts of CMC/Quality sections of the submission file.

  • Understand the regulatory expectations to meet in CMC/Quality documentation throughout the different phases of clinical development for approval of these types of medicinal products and for demonstration comparability during life cycle management.

Skills

  • Evaluate and organise information provided by CMC/Quality stakeholders during product development and post-approval.

  • Prepare regulatory CMC/Quality strategies, consider both FDA and EU aspects throughout the clinical development.

  • Evaluate relevant regulations and guidelines for biopharmaceuticals.

Competencies

  • Apply best practice in product characterisation and setting of release/stability specifications of a biopharmaceutical, including comparability issues related to manufacturing changes, when preparing a CMC/Quality meeting with Authorities, and when structuring the CMC/Quality sections for IND/CTA and BLA/MAA in the CTD format.

Lectures and group work on case stories as well as self-study of course literature.

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 before the course, especially the ICH Q4M: M4Q Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - Module 2: Quality Overall Summary, Module 3: Quality. In total corresponding to approximately 1400 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

This course is connected to the exam SMRMIF003E SMRMIF007E Exam in Biopharmaceuticals – Quality Development and Documentation. Exam registration is highly recommeded, and to earn the full ECTS credits of the course, you are required to pass the exam.

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

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

Knowledge

  • Understand the basic principles of manufacturing biopharmaceuticals - from the recombinant starting material to the final product, including product characterization and setting specifications as well as the specific quality issues of biopharmaceuticals.

  • Understand the critical parts of CMC/Quality sections of the submission file.

  • Understand the regulatory expectations to meet in CMC/Quality documentation throughout the different phases of clinical development for approval of these types of medicinal products and for demonstration comparability during life cycle management.

Skills

  • Evaluate and organise information provided by CMC/Quality stakeholders during product development and post-approval.

  • Prepare regulatory CMC/Quality strategies, consider both EU and FDA aspects throughout the clinical development.

  • Evaluate relevant regulations and guidelines for biopharmaceuticals.

Competencies

  • Apply best practice in product characterisation and setting of release/stability specifications of a biopharmaceutical, including comparability issues related to manufacturing changes, when preparing a CMC/Quality meeting with Authorities, and when structuring the CMC/Quality sections for IND/CTA and BLA/MAA in the CTD format.

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 54
  • Lectures
  • 22
  • Theory exercises
  • 5
  • English
  • 81