Practical advice for working with regulators
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.
Learning objectives:
• 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.
About Dr. Shamiram Feinglass:
Shamiram R. Feinglass, MD, MPH is the Chief Medical Officer for Danaher DxLS. Driving inclusion and diversity in every environment in which she works or leads, Dr. Feinglass leads Global Medical Affairs, Reimbursement, & Health Policy for Life Sciences and Diagnostics and is responsible for co-leading the global pandemic response plan across the company, inclusive of all 70,000 associates. Often working with global leaders and regulators, Dr. Feinglass formerly led Global Medical and Regulatory Affairs at Zimmer, Inc., has served as a Medical Officer at the Centers for Medicare and Medicaid Services, in the Coverage and Analysis Group, and as a Commander with the U.S. Public Health Service. She has also been clinical faculty at several health sciences universities and her work has been widely published.
A graduate of Smith College, Dr. Feinglass earned her Doctor of Medicine and Master of Public Health from the Emory Schools of Medicine and Public Health. She completed an Internal Medicine Residency at Oregon Health Sciences University, a Preventive Medicine Residency at Emory School of Medicine, and the Robert Wood Johnson Clinical Scholars Program at the University of Washington. A sought-after speaker and expert in international medical device and diagnostics policy, Dr. Feinglass has served on a variety of panels for the FDA, FasterCures, The Brookings Institute, Pew Charitable Trusts, Oxford University, and international registry groups. A mother of two, she is currently a BMX state champion and was a member of the USA BMX World Championship Team. Dr. Feinglass was an Aspen Health Innovators Fellow and is a member of the Aspen Global Leadership Network. She urges everyone to get vaccinated when they can.