Course Overview:

The globalization of research and development considering collaborative arrangements among companies for producing biotechnology-derived products often raises product comparability issues which are expected to increase in frequency and complexity. Comparability studies are of major importance in the development of biopharmaceuticals. For new products, such studies may be needed to qualify sources of clinical trial materials following process development, optimization, and scale up as progress through the clinical development phases is made. Comparability studies are also key to the development of biogenerics or biosimilars.

This 2-day course will present practical insights into:

Regulatory considerations in performing comparability
How comparability studies can be used in risk assessment and management
ICH Q5E Quality documents - guidance on demonstrating comparability
Handling of comparability by the European regulatory authorities
Non-clinical and clinical study considerations for the demonstration of comparability
Challenges of developing and setting-up a comparability study
Preparation of a comparability protocol
Analytical comparability and product characterization
What are the acceptance criteria for comparability studies

$850.00 USD