Generics and 505(b)(2) Events has now teamed up with Scientists Advancing Affordable Medicines, Inc. (SAAMnow) to disseminate the rapidly evolving, in vitro and in vivo research in this field. SAAMnow is a new organization (non-profit status pending) that seeks to provide a dedicated and a comprehensive platform for scientists to share cutting-edge research that facilitates the development of high-quality, affordable medicines, thereby improving their accessibility to patients. For more information, membership details and to register for this year’s event, please visit: https://saamnow.com
Generics & 505(b)(2) Events
Achieving Access to Complex Drug Products: Integrating Scientific and Regulatory Expectations
Generics and 505(b) (2) Events is an organization with objectives of identifying and bridging key gaps between emerging scientific testing methods and existing regulatory pathways for the approval of safe and effective pharmaceutical products. Our primary mission is to disseminate regulatory and scientific expertise to enable greater adaptation of best practices by the pharmaceutical industry. Our symposiums provide insights into methodologies that help overcome barriers to development and enable improved understanding of critical quality attributes that impact formulation performance. We focus on providing updates on global harmonization efforts to enable the design and conduct of more efficient bioequivalence studies and address pertinent questions on issues such as innovator drug availability as well as current and novel approaches for product development. We have focused on the increased utilization of biopharmaceutics principles for guiding formulation strategy and predicting in-vivo performance without the need for multiple clinical studies. Due to the increasing demand for safe and effective products, the FDA has prioritized research in reliable and reproducible scientific tools to help understand chemical and biological complexity and establish surrogate models that are predictive of clinical performance. Our goal is to support and propagate these efforts.
Regulatory, Industry and Academic experts are invited to address the current challenges in the development and approval of pharmaceutical products and share their insights and experiences. The symposium will share learnings and collectively build a harmonized scientific framework encompassing tools that are translatable to support a robust regulatory process. These efforts will help guide both development and product approval thereby improving patient access to high quality, safe, and affordable medicines.