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April 14, 2021 3:00 pm Virtual
As the global medical practice undergoes drastic change, getting the regulatory strategy right from the onset can mean the difference between success and failure. This webinar discusses the key considerations for registering innovative products and changes to existing products. Alternative pathways for TGA, EU, and the US will be examined, including rare-disease designations, priority review, and provisional approvals. Special note will be taken on the impacts of MDR and IVDR as well as Real-World Evidence, MDSAP, and risk-based biocompatibility.
Presenter: Luis Jimenez, Brandwood CKC
If you have questions on this topic, please submit them to help@brandwoodckc.com by April 9, 2021.
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