Two-part webinar series: Navigating the Regulatory Journey From Nonclinical To Early Phase Clinical Trials

Two-part webinar series: Navigating the Regulatory Journey From Nonclinical To Early Phase Clinical Trials

For our session covering nonclinical considerations on 8 February, register here.
For our session covering clinical considerations on 15 February, register here.

You can attend one or both sessions, although it is recommended to attend both as there will be some crossover between topics. If you cannot attend the live webinar, registrants will be sent details of the on-demand session once it is available.

Welcome to our two-part webinar series ‘Navigating the Regulatory Journey From Nonclinical To Early Phase Clinical Trials’.

Being first to market with an innovator drug remains the ultimate goal for all and most organisations are constantly reviewing timelines in order to achieve efficiencies through trial design, conduct and the reduction of down time between phases of their drug development. As a small biotech, how can you ensure that your asset is ahead of your competitors without the weight, or budget, of a larger organisation to support the process?

Over the course of these two presentations we will be examining the transition from nonclinical to early clinical from a regulatory perspective and highlighting the key areas where your program can benefit from some forward thinking and planning for your next steps.

Register for both sessions to learn:

▪ Why nonclinical studies are conducted
▪ Important aspects of the nonclinical findings to support Phase I Clinical Trials
▪ How to determine starting and maximum doses based on nonclinical data
▪ Mitigate issues with your CTA application
▪ Risk vs benefit plus novel trial design
▪ Dosing considerations for your FiH study