The SPARK-BIH 𝗣𝗿𝗼𝗴𝗿𝗮𝗺 is pleased to invite you to the next session of its expert-led webinar – this time gain practical guidance and insights in early development on how to impress potential investors and regulatory authorities with your pre-clinical package.
In this session, we will cover:
• Common pitfalls that delay clinical trial approval and how to avoid them.
• How can a minimum viable preclinical data package for first-in-human studies look like.
• Key regulatory expectations for nonclinical safety, pharmacology, and CMC.
• Which tests should you rather outsource to CROs?
• Designing efficient toxicology strategies (what is essential vs. what can be deferred).
• Translating in vitro and in vivo data into a clinical development strategy.
If you are looking at what regulators expect and how to avoid common pitfalls in early development for small molecules, this session will provide valuable hands-on insights.
More info to the flyer.
Please regiter HERE
