What happens after your investigational medicinal product (IMP) is manufactured? Can your CMO label, package, and store your drug candidate? What details do you need to have ironed out before you ship your IMP?
In this webinar, we team up with Berkshire Sterile Manufacturing to answer all of your questions and more to give you an end-to-end overview of your clinical trial manufacturing and supply process. We will give a brief overview of the sterile fill-finish process then an in-depth review of the transfer process to a packaging and distribution company with special considerations for high-value and unstable products. Sharp will then take the stage to discuss decisions you will need to make in labeling, QP, and importation, and regulatory considerations when conducting clinical trials in Europe versus the United States.
What you will learn
- How IMP is labeled, kitted, stored, and distributed
- Regulatory considerations when conducting a clinical trial in Europe vs. US
- What decisions you need to make in labeling, QP, and importation