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Overview
What have we learned from our experience with COVID-19 and how does it continue to impact the life sciences industry? What are the key regulatory developments and enforcement trends that we need to be aware of? Join our expert faculty of life sciences practitioners, in-house counsel, government regulators, and educators, as we examine the current state of life sciences law and what the future might hold. This program will cover the explosive growth of digital health and the legal issues that come with it; the latest regulatory developments at the FDA; as well as recent trends in pricing and reimbursement, effective compliance and investigation practices, and enforcement.
What You Will Learn
Upon completing this program, participants will be able to:
- Discuss FDA reform and understand what to expect from the FDA user fee reauthorization legislation
- Summarize recent developments and key regulatory considerations in digital health
- Understand market access issues for innovative medical products
- Strategize on compliance program effectiveness and investigation best practices
- Understand enforcement trends impacting the drug and device industries
Program Level: Overview
Prerequisites: An interest in the law and business of pharmaceutical and life sciences companies.
Advanced Preparation: None