OCT 27-29, 2025 | REGISTER

Science & Regulatory

Sciences and Regulatory Issues

Our science and regulatory affairs tracks will provide up-to-date insight and context to today’s developments and trends so you can better navigate the twists and turns of the regulatory landscape for generic and biosimilar drug applications. You will have the opportunity to hear from subject matter experts, as well as engage with them and other experts from FDA, industry, and academia, to better inform your business strategies and optimize your results.

Topics:

  • Common Deficiencies for ANDAs and Supplements
  • Complex Generics
  • CUHFS: Un-cuffing FDA to Explore More Efficient Human Factors Evaluation Methods
  • Current State of Generic Assessment Process and How Industry and FDA Can Collaborate to Enhance the Process
  • Essential Drug Delivery Outputs (EDDOs)
  • Evolving SUPAC for Today’s Complex Products
  • Inspection Challenges, Efficiencies, and Opportunities
  • Managing Emerging Quality Threats and Challenges: HFAs, Nitrosamines, PFAS, TiO2, Extractables/Leachables, FD&C Red No. 3, and Petroleum-Based Food Dyes
  • Nitrosamines, Nitrosamines, Nitrosamines
  • Ophthalmic and nasal combination products
  • The Future of Quality and Maintaining a Resilient Supply Chain
*Topics are subject to change

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

GRx+Biosims™ is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Get the latest information directly from Food and Drug Administration experts, understand the latest policy that impacts the industry and gain valuable insights to advance your professional development

BIOSIMILARS LEARNING TRACK    LEGAL/POLICY LEARNING TRACK