- June 23, 2021
9:00 AM - 5:00 PM ET
This conference is FREE and part of the SBIA Regulatory Education for Industry (REdI) series.
About This Meeting
The purpose of the public workshop is to provide an overview of the status of current science and research initiatives for generic drugs and an opportunity for public input on these initiatives. The public workshop also fulfills FDA’s commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its FY 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research Initiatives.
FDA is particularly interested in receiving input from industry and other interested stakeholders on the following five topic areas:
- What research is needed to determine how formulation differences in generic injectable products (that are not qualitatively (Q1) and quantitatively (Q2) the same as their reference listed drug products) affect the substitutability of these products?
- What research is needed to prepare for generic versions of oligonucleotide drug products (e.g., siRNA, chemically modified, antisense oligonucleotides)?
- What research relating to artificial intelligence (including machine learning) and/or the use of integrated data from multiple areas may facilitate and modernize the development of generic products?
- What research is needed to bridge the gap between existing scientific insights from GDUFA-funded research (e.g., related to product characterization techniques or modeling and simulation tools) and the development of suitable test procedures, study designs, model integrated evidence, and/or approaches for developing generic products?
- What research is needed to support identification of best bioequivalence practices and convergence of global bioequivalence standards?
Specific presentations and discussions at this workshop will be announced at a later date and may differ from the topics above.
The workshop includes three interactive breakout sessions with speakers from the generic drug industry and a panel discussion.
Session 1: Model-Integrated Evidence for Generic Drug Development
This session will focus on:
- Assessing the regulatory utility and knowledge gaps related to implementing modeling and simulation (e.g., computational fluid dynamics coupled with PBPK models) for orally-inhaled products.
- Leveraging model integrated evidence for long-acting injectables to reduce regulatory barriers.
- Identifying opportunities and challenges for utilizing artificial intelligence (e.g., machine learning and natural language processing) to support generic drug development and review.
Session 2: Complex Product Characterization and Analysis
This session will focus on:
- Exploring the main gaps that industry and others see in complex generic product characterization and analysis, and clarifying the types of products that should have more focus.
- Discussing which new analytical methods are promising for generic drug development, screening, quality surveillance, etc. These discussions will consider access and availability by industry, cost, and acceptance, and identify which plans or considerations need to be put in place to encourage adoption of new technologies by the generic drug industry.
- Assessing analytical methods currently seen to be most useful, and discussing what can be done to better develop these technologies. The rationale for sampling and the numbers of batches to assess for batch-to-batch variability for various types of complex products will also be discussed.
Session 3: In Vitro and In Vivo Bioequivalence Approaches: Challenges and Opportunities
This session will focus on:
- Considering the utility of in vitro characterization and modeling approaches to support biowaivers for certain (e.g., non-Q1/Q2) formulations of prospective generic products.
- Discussing the design, conduct and data analysis of in vivo bioequivalence studies, including the study design and the selection of appropriate subject or patient populations for studies that support a demonstration of bioequivalence for complex products, including oncologic products.
Generic drug industry stakeholders including scientists/researchers, clinicians, regulatory affairs professionals, and patient advocates who work on or are interested in research that advances the development of generic drugs.
- Federal Register Notice
- OGD: Science and Research
- FY 2020 GDUFA Science and Research Report
- FY 2021 GDUFA Science and Research Initiatives
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
- has been pre-approved by RAPS as eligible for credits (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
- has been pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
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