Legal and Policy

Legal and Policy Issues Currently Facing the Industry

Be a part of the discussions on pressing legal and policy challenges facing the industry. We will explore the critical role that 180-day exclusivity plays in accelerating patient access to generic medicines. This track will discuss the causes and potential policy solutions to prevent and mitigate drug shortages. This track also will share important updates on the CARES Act and discuss the impact of the Omnibus Bill on the generics industry. Finally, this track also will address Q1/Q2 assessments in the product development phase of ANDAs.

Who should attend:

Possible job titles include:
Regulatory Affairs, Medical Affairs, Business Development, Program Management, Policy, Commercial Development, Scientific Affairs, Research Analyst

About GRx+Biosims 2023

GRx+Biosims 2022 is the premier scientific and regulatory event for the U.S. generics and biosimilars industries, featuring timely programming relevant to technical, regulatory and policy professionals. Top officials and subject-matter experts share their knowledge and best practices to enhance attendees’ understanding of how to succeed in generic and biosimilar development; the regulatory process and approvals; and the evolving policy landscape.