Patents & FDA Regulation of Pharmaceutical Products – Webinar Recording/Transcript
Do you know how to talk to your patent attorneys and IP specialists about relevant regulatory and compliance mandates? Has your team considered the importance of exclusivity? Are you moving down one of the two major pathways — Hatch-Waxman and Biologics Price Competition and Innovation Act (BPCIA) — to enable generic and biosimilar drug development?
These questions, and the way they’ll help advance your patent and intellectual property needs, might just be the key to your product’s success.
Through the Patents & FDA Regulation of Pharmaceutical Products presentation, you’ll get a broad look at how patents and IP relate to drug development and discover how these processes work to provide market exclusivity, keeping competitors at bay.
Patent attorney Joanna Brougher will share the strategies companies can use to develop strong patent portfolios. She’ll also explore how to protect your product against competitors by supplementing those patent strategies with FDA exclusivities.
- How patents and the FDA regulatory process overlap, including during the drug approval process
- The differences between patent exclusivity and FDA exclusivity, including compliance
- The various types of FDA exclusivity available and what that means to regulatory specialists
- Strategies for using exclusivity to build a strong patent portfolio and protect against competitors
- Reasons drugs manufacturers should understand strategic patent processes
- Potential weaknesses in patents and how FDA exclusivity can help maintain market protection
- How orphan drug and pediatric exclusivity can encourage drug development
Building a strong patent portfolio and gaining a deep understanding of FDA exclusivity can help protect the drugs you’re developing from competitors and provide a path toward its market success. Ensure you and your team understand these processes with this essential presentation on patents and IP issues.
Meet Your Presenter
Joanna Brougher is a patent attorney who focuses on all service aspects in the areas of biotechnology, pharmaceuticals and medical devices, including patentability opinions, due diligence, patent drafting, domestic and foreign patent prosecution, development and management of patent portfolios, and general counseling. She assists clients through all phases of a product’s lifecycle, from conception to commercialization. She also has experience counseling clients on the Hatch-Waxman Act and monitors developments involving biosimilars under the Biologics Price Competition and Innovation Act.
Who Will Benefit
- Biotech and pharmaceutical companies
- C-level executives
- Regulatory professionals
- Quality professionals
- Compliance specialists
- GMP professionals
- Inspections and audit staff
- Post-market safety staff
- Submissions and approvals professionals
- Research and development staff
- Commercial operations staff
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Oct. 22, 2020