#scientific #guidelines #guidance #biologics

Scientific guidelines and guidance related to biologics in the EU are official documents developed by the European Medicines Agency (EMA) to support the development, evaluation, and regulation of biological medicines, ensuring their quality, safety, and efficacy within the European Union.

Discussion on
1. Scientific guidelines and guidance related to biologics in EU
2. Similar biological medicinal products
3. Immunogenecity assessment of biotechnology derived proteins
4. stability testing of biologics
5. Clinical investigation of pharmacokinetics of proteins
6. Preclinical safety evaluation
7. development, production, characterization and specificao
8. comparability of biologics
9. Human cell based medicinal products

Видео #scientific #guidelines #guidance #biologics канала JITENDRA PATEL