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SPARK-BIH webinar: A Practical Pre-Clinical Guidance for Regulatory Success for Small Molecule Projects

Register to join online here.

Dr. Reiner Class is the CEO of C-Square Consulting GbR and Associate Analyst at UCB Ventures, who brings 35+ years of experience in drug discovery and preclinical development, including large pharma. Reiner will explain some key components and provide practical guidance that scientists need to consider for accelerating progress towards clinical trial approval.

 

In this webinar, he 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.

·       Designing efficient toxicology strategies (what is essential vs. what can be deferred).

·       Which tests should you rather outsource to CROs? 

·       Translating in vitro and in vivo data into a clinical development strategy.

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15 June

East Midlands Tech Week

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22 June

BIO International