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Overview
Why You Should Attend
What does the future direction of judicial review of FDA actions, including FDA rulemaking and FDA actions on medicinal products look like? What policies and processes has FDA established to encourage diverse participation in clinical trials? How are laws and regulations adapting to use of digital technologies like AI/ML, large language models (“chat”), and the metaverse in the life sciences industry? How are new drug pricing authorities being implemented and how is the legal landscape for coverage and reimbursement changing? What are the key aspects of an effective compliance program? 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 relationship of FDA and courts, the explosive growth of digital health and the legal and regulatory issues that come with it; clinical trial diversity and reforms; the latest developments in FDA compliance priorities; as well as recent trends in pricing and reimbursement, effective compliance and investigation practices, and enforcement.
What You Will Learn
After completing this program, participants will be able to:
- Discuss the practical significance of recent Supreme Court cases on the relationship of FDA and courts
- Understand the impact of clinical trial diversity on health equity and current clinical trial guidance as well as possible reforms
- Be familiar with the legal and regulatory developments concerning use of AI/ML, large language models, and other software applications in digital health
- Be familiar with the latest developments in pricing and reimbursement issues for pharmaceuticals and medical devices
- Understand enforcement trends impacting the drug and device industries
- Strategize on compliance program effectiveness and investigation best practices
Who Should Attend
This program is designed for attorneys and allied professionals who counsel pharmaceutical and life sciences companies.
Program Level: Overview
Prerequisites: An interest in the law and business of pharmaceutical and life sciences companies.
Advanced Preparation: None