Registration:

For faculty and students from the University of Maryland, Baltimore; Universities at Shady Grove; and University of Michigan, the workshop is free for in-person attendance. Please contact us (info@complexgenerics.org) and indicate which workshop you are interested in.

Continuing education (CE) credits will not be provided for attending this workshop. A certificate of attendance will only be provided to individuals attending the workshop in-person.

About the Event:

Characterization of complex excipients and/or formulations is essential for developing generic products with respect to facilitating reverse-engineering, supporting qualitative (Q1) and quantitative (Q2) sameness (when applicable), developing methods for quality control (QC), supporting bioequivalence (BE) and exploring an alternative in vitro BE approach. However, development of “fit for purpose” characterization methods may not be straightforward, depending on the complexity of the excipients and/or the formulation.

The purpose of this two-day workshop is to discuss the scientific principles and practical considerations that inform current FDA thinking about the characterization of complex excipients and formulations to support generic product development and assessment. The workshop will provide an update on the progress of research activities funded by the Generic Drug User Fee Amendments (GDUFA) science and research program, explore challenging issues that would benefit from a broader discussion, identify areas that need further research, and discuss opportunities for coordination and collaboration among the FDA, generic drug industry, academic institutions, excipient vendors, contract research organizations, consultants, and other stakeholders.

Hybrid Experience:

The workshop will offer both in-person and virtual attendance options. The event will be held at the Universities at Shady Grove in Rockville, Maryland.

For those attending virtually, information on accessing the Zoom webinar can be found in the registration confirmation email or other emails from Zoom. If you have trouble accessing the virtual workshop, please email info@complexgenerics.org.

Workshop Topics:

Characterization of complex excipients (e.g., polymers) to support regulatory and scientific needs during product development and regulatory assessment
Potential alternative in vitro and/or in vivo studies to support product development and demonstrations of BE for complex dosage forms, including injectable, insertable and ophthalmic products
Regulatory experience with assessing complex dosage forms, highlighting FDA’s research to support the development of product-specific guidances and the assessment of Abbreviated New Drug Applications (ANDAs).
Opportunities for utilizing new technologies to support the development and assessment of prospective generics with complex dosage forms and formulations

FDA and the Center for Research on Complex Generics (which is a collaboration between the University of Maryland School of Pharmacy and the University of Michigan College of Pharmacy) are dedicated to advancing programs that stimulate scientific dialogue, disseminate current insights about complex generics, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines.

Audience:

This workshop is primarily developed for the generic drug industry and other involved collaborators, including consultants and contract research organizations whose work supports generic drug applications.

Registration Fees:

The cost for in-person attendance is $500 and will cover event-related expenses. This workshop is FREE for virtual attendees.

Characterization of Complex Excipients and Formulations