Biopharmaceuticals - Quality Development and Documentation

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.

This course will provide you with an understanding of the basic principles of manufacturing biopharmaceuticals – from the recombinant starting material to the final product. This include product characterization and setting specifications as well as the specific quality issues of biopharmaceuticals. You will also be able to evaluate relevant regulations and guidelines for biopharmaceuticals.

You will learn about the critical parts of CMC/Quality sections of the submission file, evaluate information provided by CMC/Quality stakeholders and prepare regulatory CMC/Quality strategies consider both FDA and EU aspects throughout the clinical development.

You will be able to 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.

Innovate and strengthen the regulatory process  

The course is intended for regulatory affairs specialist employed in industry, regulatory agencies or consulting.

Participants must

• Hold a relevant bachelor degree or equivalent
• Have a minimum 2 years of relevant job experience
• Be proficient in English

Find detailed information about the admission criteria.

This course is offered as a fixed elective course on the Master of Medicines Regulatory Affairs programme.

Priority is given to students enrolled on Master of Medicines Regulatory Affairs. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.

You must choose minimum one of the fixed elective courses to complete the Master of Medicines Regulatory Affairs programme. 

Atrium is a partner of Master of Medicines Regulatory Affairs. This course is one of 5 courses at the Master's programme, which are offered in collaboration with Atrium.

Atrium is one of Europe’s leading private course providers of practice-based courses in Regulatory Affairs. Their courses are based on collaboration with academia, industry experts and representatives from healthcare authorities.

International educational academy

Atrium is an international educational academy established by The Danish Association of the Pharmaceutical Industry (Lif). As a part of the Danish Association of the Pharmaceutical Industries, Atrium has a close connection to the experts in the Pharmaceutical Industry.