CMC for Biologicals

• Regulatory framework: ICH guidelines
• 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?

Who should attend

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. 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.

• The references to regulatory requirements/guidelines, the overview of required studies that are reviewed by the authorities prior to market authorisation" were extremely helpful for participants last year.
• "A very good overview of the relevant topics" is how one person would characterise the event to their colleagues.