Add to Your Calendar
Pharmaceutical product labeling is a critical aspect of bringing a drug to market, but it involves more than just meeting regulatory requirements. It is a multifaceted process that intersects with various legal domains, including intellectual property, product liability and mass torts, FDA regulations, and white-collar crime.
Join us for an insightful webinar where Venable partners will share their perspectives on the do's and don'ts of pharmaceutical product labeling. This session will provide valuable guidance to help you navigate the complexities of labeling compliance, protect your intellectual property, mitigate liability risks, and avoid potential legal pitfalls.
Key Topics to be Covered:
- Intellectual Property Considerations (Whitney Meier Howard): Learn how to safeguard innovations through strategic labeling practices. We’ll discuss how to align label language with patent claims to support patent infringement and avoid common noninfringement arguments.
- Product Liability and Mass Torts (Shannon Beamer): Understand how labeling is attacked by plaintiffs in products liability litigation, including how communications to FDA regarding labeling negotiations are exploited. Gain insights into the state of the preemption defense and how companies can best position themselves to take advantage of the defense.
- FDA Regulations and Compliance (Justin Coen): Get up-to-date on the latest FDA labeling regulations and guidance. Discover best practices for ensuring that your product labels meet FDA standards and avoid common regulatory pitfalls.
- White Collar Crime Implications (Matt Murphy): Explore the intersection of labeling practices with potential white-collar crime issues, including what to expect if your company learns that it is being investigated by government authorities or uncovers issues internally. We’ll discuss best-practices that can help ensure efficient and effective ways to protect your company from exposure to prosecutors and regulators.