Orphan drugs are vital for those people with rare diseases and this is recognised by Regulators in Europe and the US. By gaining orphan designation, pharmaceutical companies access various incentives to encourage them to develop therapeutics for patients with rare diseases. However, it is important the system is not misused and that you fully understand the regulatory requirements and roadmap.
This training course will provide you with a comprehensive understanding of the opportunities and challenges offered by orphan drug designation. Once completed, you will understand the regulations and whether they are applicable to your product. Through practical exercises you will examine multiple orphan drug examples so you have the confidence to navigate the regulations.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.