CMC for Biologicals - With a focus on proteins

Die Themen

- Regulatory framework: ICH guidelines (including an outlook on the new (Draft) ICH Q1 and ICH M4Q(R2)) - Essential data for biologics for Module 3 - Challenges in Module 3: Focus on antibodies, immunoglobulins and recombinant proteins - Comparability requirements for changes - Critical data: Which data must be included in the dossier, which not?

Ziele

The requirements for Module 3 of the CTD differ fundamentally for biotech products from those for non-biologics. During this online training, you will gain knowledge with regard to CMC management specifically for biologicals.

- After participating in the seminar, you will be familiar with the ICH guidelines, which form the regulatory framework (including an outlook on the new (Draft) ICH Q1 and ICH M4Q(R2)). You will know which data are required for Module 3 and which significant differences exist to non-biologics. You will know the specifics of the documentation for antibodies, immunoglobulins and recombinant proteins and have been provided with practical solutions. Our experts will discuss the comparability requirements in the event of a change by means of a case study.

- Finally, you will work out in the workshop which data is mapped in the dossier and how, and learn how to skilfully avoid common mistakes.

Wer sollte teilnehmen?

This online training is aimed at specialists and managers in the biopharmaceutical industry who are responsible for creating and maintaining the quality module in the CTD or who make a significant contribution to this.

- Especially addressed are the departments of regulatory affairs, medical science, quality assurance and quality control.