Workshop | In Person
Event Title
Regulatory Education for Industry: Advancing Innovative Science in Generic Drug Development Workshop
September 29 - 30, 2020
- Date:
- September 29 - 30, 2020
Slides and Recordings
Update on GDUFA Science and Research
March 2020 Transition Under the BPCI Act: Impact on Generics
Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products
Non-clinical Evaluation of Immunogenicity Risk of Generic Complex Peptide Products
Panel Discussion on Method Development / Validations for Non-traditional Analytical Methods
Developing and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence
Developing & Validating Commonly Employed Particle Sizing Methods to Support BE and Product Quality
Quantitative Methods for Determining Equivalence of Particle Size Distributions
Panel for Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions
Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies
In Vitro Release Testing for Complex Generics: A Bioequivalence Perspective
In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of IVRT and IVPT
Panel on Development and Validation Considerations for Drug Release and Permeation Testing
Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness
Calculating Maximum Daily Dose (MDD) for Orally Administered Drug Products
What’s New in the Inactive Ingredient Database (IID)?
Local Toxicity Considerations for Qualifying Excipients in Generic Drugs
Panel on Excipient and Formulation Considerations
In Vitro Studies for Alternative BE Approaches to Comparative Clinical Endpoint BE Studies
The Potential of PK BE Studies in Detecting Regional Deposition with Orally Inhaled Drugs
Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation
Panel on Future Directions, Emerging Technology, and Current Thinking on Alternative BE Approaches
Topical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches
In Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches
Non-Invasive Raman Spectroscopy-Based Bioequivalence Approaches
Panel on Topical Dermatologic Products
PBPK to Guide Study Design and Product Development for Generic Dermatological Products
Model-Informed and Model-Integrated Approach in BE Assessment of Long-Acting Injectable Products
Panel on Emerging Use of Modeling and Simulation for Bioequivalence
Biopharmaceutics Classification System Class 3 Waiver
Using PBPK Absorption Modeling to Support Biopharmaceutics Classification System Class 3 Drug Waiver
Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and MSD Method
Panel on Practical Considerations in the Study Design and Data Evaluation Recommended in PSGs
A Closer Look into the Nasogastric and Gastric Feeding Tube Study Recommendations
In Vitro Enteral (Nasogastric and Gastric) Feeding Tube Testing of Generic Drugs: Case Studies
Practical Considerations for Bioequivalence of GI Locally-Acting Products
Panel on In Vitro Feeding Tube Testing and GI Locally-Acting Products
Our annual REdI: Complex Generic Drug Product Development Workshop has been renamed in 2020 to the “REdI: Advancing Innovative Science in Generic Drug Development Workshop.” As in previous years, the SBIA conference will advance the same concepts to help the generic industry pave a clear scientific pathway for generic drug development…and just as important, it is at no cost.”
We will focus on common scientific issues seen in Abbreviated New Drug Applications (ANDAs), commonly known as generic drug applications. We will link GDUFA science and research on complex products and complex scientific issues to product-specific guidance development, discuss pre-ANDA meetings and assessment, and examine various areas of the science behind generic drug development.
SESSIONS
- Method Development / Validations for Non-traditional Analytical Methods
- Complex Active Pharmaceutical Ingredients Including Peptide Products
- Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions
- Development and Validation Considerations for Drug Release and Permeation Testing of Complex Dosage Forms
- Excipient and Formulation Considerations
- Future Directions, Emerging Technology, and Current Thinking on Alternative BE Approaches
- Nasal and Inhalation Products
- Topical Dermatologic Products
- Emerging Use of Modeling and Simulation for Bioequivalence
- Practical Considerations in the Study Design and Data Evaluation Recommended in PSGs
- Oral Products
- In Vitro Feeding Tube Testing and GI Locally-Acting Products
INTENDED AUDIENCE
Scientists, researchers, and regulatory affairs professionals who work on or are interested in working on the development of generic drugs.
REFERENCES
- Generic Drugs
- Product-Specific Guidances for Generic Drug Development
- Upcoming Product-Specific Guidances for Complex Generic Drug Product Development
- FDA Guidance Documents
- Generic Drug Science & Research
Event Materials
| Title | File Type/Size |
|---|---|
| Innov-Generics-2020-Agenda | pdf (312.78 KB) |