4^th Bioequivalence Conference

Since the adoption of the ICH M13B Guideline on Additional Strengths Biowaivers and the rapid advancement of modelling and simulation approaches in drug development, this conference offers a timely opportunity to gain insights into evolving regulatory expectations and innovative scientific applications. Attendees will hear from regulators and industry experts on how recent progress in the field is shaping the future of generic drug development and lifecycle management.

The conference will provide a platform for an exchange of views between industry and regulators on the following topics:

• Regulatory perspectives on the application of modelling and simulation approaches in drug development and assessment
• Current and emerging uses of modelling and simulation to support generic drug development
• Q&A session with regulators to clarify key aspects of the ICH M13B guideline on Additional Strengths Biowaivers