In vitro diagnostic (IVD) products enable the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. Regulatory agencies have a critical role to play in protecting public health and with IVD products primarily used in the collection, preparation, and examination of samples from the human body they need to ensure they are safe, accurately labelled and effective. Given the scale of the responsibility, a complex and lengthy approval process can sometimes prevail.
With so many elements involved in the development of diagnostic kits and particularly novel tests, developers, scientists, and researchers, often find the regulatory approval process cumbersome and a potential barrier to commercialization.
Join Dr. Shamiram Feinglass, CMO & VP Global Medical Affairs and Policy at Danaher, for top tips on how to work with the regulators effectively, the key steps in the process and what you can do to ensure a successful regulatory outcome.
Understand the role of government agencies and regulatory bodies in the development of diagnostic tests
Review the impact of unexpected global health trends on the approval of novel tests
Consider the timelines, steps, and challenges in the regulatory approval process
Learn how to work with regulators for successful filing.