FDA updates regarding Use of Real World Data; FDA updates on Artificial Intelligence (AI) and digital health technologies.
FDA updates regarding Use of Real World Data: The lecture will describe the regulatory updates regarding use of Real World Data to support marketing applications.
FDA updates on Artificial Intelligence (AI) and digital health technologies: The lecture will describe FDA’s approach to AI and digital health medical devices.
- Speaker: Ahava Stein
New Reliance Framework for Marketing Authorization Applications of Medicinal Products in Israel.
The presentation will focus on a pilot launched in April 2025 regarding reliance pathways by IMOH
Eligibility Criteria for each pathway, timelines and insights.
- Speaker: Dr. Nira Mizrotsky:
From a drug development to an NDA submission – challenges and regulatory milestones.
The talk will discuss the milestones we passed from drug development towards an NDA submission to the FDA with the regulatory challenges through an example of our drug product.
- Speaker: Dalit Fellous Hazan
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
