November 4-6, 2019 | North Bethesda, MD


Have a suggestion?

When we say “Be Part of the Solution,” we mean it. For GRx+Biosims 2019, we are working to create a conference that features valuable, up-to-the-minute programming relevant to what our participants are doing in the field.

To that end, we are seeking suggestions for topics that reflect the best thinking in the field, informed by research, expertise and experience. If you have an idea that is informative, innovative and engaging, please take the time to submit your idea via the form below.

Don’t miss out on the opportunity to shape the discussion at the premier scientific and regulatory event for the U.S. generics and biosimilars industry, submissions are unlimited but must be submitted by June 28th. Additionally, to show how much we value your participation, we plan to reward topic suggestions with a special gift. We look forward to seeing your ideas!

2018 session topics are included in the list below. Please send us a message and let us what sessions you would like to see again in 2019 or suggest us a new topic.

• Rising Drug Prices and Sustainable Competition
• State of the Industry
• Global Experience with Biosimilars
• Data Integrity
• Perspectives on the Future of ICH
• Drug Pricing and Update on State Legal Issues
• USP Stakeholder Engagement Through Monograph Development
• Biosimilars Regulatory Expectations & Experiences
• What’s Important to Consider When Developing a Complex Generic Drug
• Prescriptions Drug & Opioid Abuse – Prevention Education
• Successfully Managing Priority Generic Submissions
• Breaking Through Biosimilars: Market Development & Access
• FDA’s Center for Drug Evaluation and Research: Informatics Initiatives to Modernize the Generic Drug Review Process
• Telling Your Company’s Story
• Serialization for Today and Tomorrow
• GDUFA II Complex Products: Pre-ANDA Meeting Process

• Biosimilars Reimbursement
• Legal Issues in GDUFA, FDARA, and Administration Proposals
• FDA Hiring and Retention Initiative – An Overview of the Agency’s HR Process
• The Role of Variability in Biosimilar Development
• Update on GDUFA and BsUFA User Fees
• Emerging Legal Issues on IP and Paragraph IV Litigation
• Uninsured, Underinsured and Disaster Access – Direct Relief
• USP Pending Monograph Process
• Amplify our Voice – Communications Task Force Meeting
• OGD Updates
• Bridging the Education Gap: Accelerating the Understanding of Biosimilars to Optimize Patient Care
• Drug Competition Action Plan and Biosimilars Action Plan
• Old, New, and Future Challenges in Bioequivalence
• The 5 Year Financial Plan for GDUFA and BsUFA
• Biosimilars at the Bar
• Modernization of Organic Impurities Testing in USP Monographs