FDA and the Center for Research on Complex Generics (CRCG) are hosting a public workshop on December 7-8, 2023: Characterization of Complex Excipients and Formulations
Workshop Date and Time:
December 7, 8:30 a.m. – 5:40 p.m. EST
December 8, 8:30 a.m. – 3:15 p.m. EST
- Register Now (if attending in person, please register by November 28, 2023)
- Agenda
- Speaker Bios
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 (remote) attendance options. The event will be held at the Universities at Shady Grove in Rockville, Maryland.
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.
Workshop Outline:
Introduction to the Workshop
The introduction to the workshop will provide a brief overview of the considerations for developing prospective generics with complex dosage forms and formulations, contextualizing the challenges with bringing more of these generics to the market, and describing FDA’s successes as well as continuing efforts to address these challenges through approaches that will be discussed during this workshop. An overview of the workshop agenda will also be provided.
- Presentations by experts from FDA
Session 1: Characterization of complex excipients that are commonly used in injectable, insertable, and ophthalmic products
In this session, FDA, academic, and industrial presenters will share the latest progress in approaches to characterize and assess complex polymeric excipients used in long-acting products during product development and regulatory assessment.
- Presentations by experts from FDA, academia, and the generic drug industry
- Audience Q&A with panelists from FDA, academia, and the generic drug industry
Session 2: Characterization of complex injectable, insertable, and ophthalmic products
This session will highlight GDUFA research efforts on complex dosage forms including injectable, insertable and ophthalmic products. The research outcomes are intended to facilitate the development of potential alternative in vitro or in vitro/in vivo BE approaches, and to provide more guidance on product assessment.
- Presentations by experts from academia and the generic drug industry
- Audience Q&A with panelists from academia and the generic drug industry
Session 3: In-Person Session
Small group discussions among FDA, academic, and industrial participants attending the workshop in person on the characterization of complex excipients, characterization of complex formulations for quality and bioequivalence purposes.
Session 4: Scientific and regulatory considerations when developing product-specific guidances and assessing ANDAs
This session will focus on various complex injectable, insertable, and ophthalmic products, and facilitate a discussion about common deficiencies and/or expectations when assessing products such as intravaginal rings. In addition, this session will include case studies to highlight FDA’s internal efforts supporting the assessment/approval of complex generic drug products, and developing scientifically sound BE approaches.
- Presentations by experts from FDA and the generic drug industry
- Audience Q&A with panelists from FDA, academia, and the generic drug industry
Session 5: Advanced technologies for characterizing complex drug products
This session will focus on how and which new advanced technologies can be used to obtain a more mechanistic understanding of complex dosage forms, such as in situ forming implants, polymeric microspheres, intrauterine systems, and nano materials.
- Presentations by experts from FDA, academia, and the generic drug industry
- Audience Q&A with panelists from FDA, academia, and the generic drug industry
Session 6: In-Person Session
Small group discussions among FDA, academic, and industrial participants attending the workshop in person on the application of advanced technologies to support generic product development and assessment and the development of in vitro bioequivalence approaches for long-acting implants.
For more information: If you have any questions about this workshop please contact info@complexgenerics.org.
