Which regulatory aspects are crucial to translate a new drug candidate into early clinical development?
Regulatory processes are essential for successful drug development, hence, for the approval of new medicines in order to bring a novel therapy to the patient. However, many drug developers wonder which experiments are actually required for their nonclinical package, or at which time point they should interact with regulatory agencies.
The online lecture aims at answering the following questions:
* What are the important aspects for the nonclinical package for early stage developments?
* What are the principally required data to translate a new drug candidate into early clinical development?
* What needs have to be taken into account for the design of the FIH study?
* How do CMC packages differ from early to late stage developments?
* How and when to interact with regulatory agencies?
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