Karl Nobert and Bernie Brown present the latest FDA topics and patent issues relevant to the life sciences sector. The presentation will focus on a combination of FDA Regulatory Law and Patent Regulation, and is intended for members of the drug, medical device, and diagnostic industries. Among other topics, presenters will address trends in FDA regulation and look at the issue of compliance from the perspective of Agency inspections and enforcement action. In terms of Patent law, presenters will focus on recent developments in the field. Attendees will:

• Understand the importance of coordinating patent life cycle with regulatory review
• Be informed of under-utilized patent targets that can expand your patent portfolio and extend life
• Current strategies for pursing patent claims for diagnostics in view of subject matter eligibility
• Leave with knowledge of recent FDA developments in each of their respective industry sectors
• Be updated on recent FDA enforcement action for purposes of improving internal compliance such as cGMP implementation
• Gain an understanding of FDA trends and what may be expected in 2022
• Be able to ask questions of the presenters related to issues that may be currently impacting their companies