Join us online Wednesday, August 19 – Thursday, August 20 9:00 am – 5:00 pm EDT for a two-day Virtual Regulatory Bootcamp, which will provide the regulatory professional and non-regulatory executive alike a foundational understanding of how the FDA reviews and regulates human medical products. This program is led by former FDA regulators with over 30 years’ experience and were responsible for regulating TEMPs, devices, and biologics. Their unique expertise can help you identify and address specific regulatory knowledge gaps. The ARMI | BioFabConsulting Virtual Bootcamp is designed to engage participants in active learning that will translate into more informed decisions during product development to bring your product to market more effectively.
Learning outcomes include:
FDA Organizational Structure & Authority
Types and Definitions of Human Medical Products
Fundamental Understanding of Combination Products & Product Jurisdiction
Understanding of the FDA Regulatory Pathways
Event Features
A Broad Coverage of Topics to Empower Regulatory Decisions
Live Q&A with Top Regulatory Consultants
Interactive Group Activities
Regulatory Tips, Best Practices and Resources
Presentation Slides to Refer to and Use to Inform Discussions with your Team
Act NOW! Limited number of seats available for the Bootcamp
ARMI | BioFab members will be offered discounted access to the event
