Navigating the Regulatory Landscape of mRNA-based Therapeutics
WEBINAR
In recent years, RNA-based therapeutics, particularly siRNA and mRNA-based drugs, have revolutionized the field of medicine. In this webinar, we will delve into the categorization of mRNA-based therapeutics in the European Union and the United States and examine the manufacturing requirements for mRNA drug substances in each region. Gain insights into the benefits of these regional differences for mRNA drug product development. Stay informed on the latest EU and US regulations impacting mRNA therapeutics, from drug substance to lipid nanoparticle (LNP) formulations. Stay ahead of the evolving regulatory landscape and discover opportunities for your mRNA drug development strategies.
In this webinar, you will:
- Understand the distinct regulatory categorizations of mRNA therapeutics in the European Union and United States
- Learn about the advantages of an EU-based mRNA drug substance manufacturer
- Gain insights into regulatory requirements for LNPs in mRNA-LNP formulation
Pharma and biopharma manufacturing
- mRNA
Duration:51min
Language:English
Session 1:presented May 14, 2024
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