Regulatory Journey to Phase I for Defined Consortia LBP: Helping Biopharma Pre-Empt Challenges Navigating Regulations in Europe
Time: 1:30 pm
day: Conference Day One
Details:
- Visibility on preclinical requirements for taking an LBP to the clinic, and navigating lack of concordance across non-clinical safety, and CMC specifications
- Sharing how biopharma can better plan to achieve regulatory milestones
- With regulatory set-backs adding time and cost to programmes, pre-empt requirements earlier to more accurately predict timelines and costs
