Charles River Biotech Symposium| Biotechnology-Derived Therapeutics Perspectives on Nonclinical Development


Sunday, September 8, 2019 (Optional Workshop)

Demystifying the Late Stages of Nonclinical Development of Biotherapeutics

The workshop will focus on late stage nonclinical scientific and regulatory strategies necessary for a successful BLA filing and marketing authorization. How to plan for and execute a US and worldwide nonclinical toxicology registration strategy based on specific requirements for biologics and share insight around regulatory procedures and the FDA review processes will be discussed. The different late-stage studies and sections of a BLA including reproductive toxicity, juvenile toxicity, carcinogenicity, and comparability assessment will be discussed in more detail also. The use of a gap analysis to assess for potential scientific and regulatory issues mid-development as well as tips for drafting appropriate supportive late-stage program documents (e.g. briefing documents, annual updates, PPSR/PIP, labels, RMP) will be shared.


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