Orphan drugs are vital for those people with rare diseases, and this is recognised by Regulators globally. By gaining orphan drug designation, pharmaceutical companies access various incentives to encourage therapeutic development. 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. You will also have a good understanding of the application process and procedure to obtain orphan drug designation. You will examine strategic considerations to ensure the most efficient regulatory path for your product. Learn more about how we deliver live online training.