4th Annual Symposium on Development of Generics & 505(b)(2): Achieving Access to Complex Drug Products Integrating Scientific and Regulatory Expectations
Thursday, September 21, 2017
DoubleTree Hilton, Somerset, New Jersey

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.

Topics & Speakers:

Mansoor Khan, R.PH., Ph.D. – Improving Access for Locally Acting GI Products

Stephanie Choi, Ph.D. – GDUFA Research and Regulatory Initiatives for Complex Ophthalmic Products

Duxin Sun, Ph.D. – Strategies for Assessing Equivalence of Complex Injectable Products

Paddy Shivanand, Ph.D. – Building a Better Product Using the 505 b(2) Pathway

Sam Raney, Ph.D. – GDUFA Research and Regulatory Initiatives for Complex Topical Products

Mathangi Gopalakrishnan, Ph.D. – Modeling and Simulation to Support Development and Approval of Complex Products

Absorption Systems
Amneal Pharmaceuticals
Carnegie Pharma
Leading Pharma
Rising Pharmaceuticals

Thank you to all of our sponsors, speakers and participants for making this year a great success – see you in 2018!