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4th Annual Development of Complex Drug Products

Generics & 505(b)(2) Events

Thursday, September 21, 2017 from 8:00 AM to 4:00 PM (EDT)

4th Annual Development of Complex Drug Products

Ticket Information

Ticket Type Sales End Price Fee Quantity
Early Bird
Early Bird Rate - Extended through September 12, 2017! Breakfast and lunch included with registration.
Ended $250.00 $0.00
Early Bird Group Discount (Package of 5 tickets)
Purchase 4 tickets and receive your 5th ticket for FREE! Receive 5 tickets for the price of 4 when you order a group package. Extended through September 12, 2017! Breakfast and lunch included with registration.
Ended $1,000.00 $0.00
Standard Registration
Standard Registration Fee, 9/1/17-9/20/17. Breakfast and lunch included with registration.
3h 8m $325.00 $0.00
Onsite Registration
Onsite Registration will be available for $400.00/attendee. Credit card and cash sales only. Available day of, at door only. Breakfast and lunch included with registration.
Not Started $400.00 $0.00
Partner Sponsorship   more info 1d 18h 9m $2,000.00 $0.00

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Event Details

4th Annual Symposium on Development of Generics & 505(b)(2)

Achieving Access to Complex Drug Products: Integrating Scientific and Regulatory Expectations 

Event Schedule:

Coming Soon! 

About the Event:

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.

Speakers:

Mansoor Khan, R.PH., Ph.D. – Improving Access for Locally Acting GI Products
Professor and Vice Dean
Director, Formulations and Drug Delivery Core Laboratory Texas A&M Health Science Center, Rangel College of Pharmacy, College Station, TX

Stephanie Choi, Ph.D. – GDUFA Research and Regulatory Initiatives for Complex Ophthalmic Products
Acting Associate Director for Science
Office of Research and Standards, Office of Generic Drugs, FDA

Duxin Sun, Ph.D. – Strategies for Assessing Equivalence of Complex Injectable Products
J.G. Searle Endowed Professor, Professor of Pharmaceutical Sciences, Director of Pharmacokinetics Core College of Pharmacy
The University of Michigan

Paddy Shivanand, Ph.D. – Building a Better Product Using the 505 b(2) Pathway
Co-Founder and Principal at JDP Pharma Consulting, LLC

Sam Raney, Ph.D. – GDUFA Research and Regulatory Initiatives for Complex Topical Products
Scientific Lead for Topical and Transdermal Drug Products
Center for Drug Evaluation and Research , Office of Generic Drugs, FDA

Mathangi Gopalakrishnan, Ph.D. – Modeling and Simulation to Support Development and Approval of Complex Products
Research Assistant Professor
Center for Translational Medicine, School of Pharmacy, University of Maryland

Have questions about 4th Annual Development of Complex Drug Products? Contact Generics & 505(b)(2) Events

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When & Where


DoubleTree by Hilton Somerset Hotel and Conference Center
200 Atrium Drive
Somerset, NJ 08873

Thursday, September 21, 2017 from 8:00 AM to 4:00 PM (EDT)


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