- September 29 - 30, 2020
8:00 AM - 4:30 PM ET
Regulatory Education for Industry: Advancing Innovative Science in Generic Drug Development Workshop
Dates: Sep. 29-30, 2020
Day 1: 8:00 AM - 4:50 PM
Day 2: 8:00 AM – 4:30 PM
Hilton Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852
and/ or Via Webcast
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This event is FREE.
ABOUT THIS EVENT
The goal of this science-focused workshop is to help the generic industry pave a clear scientific pathway for generic drug development. 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.
- 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
Scientists, researchers, and regulatory affairs professionals who work on or are interested in working on the development of generic drugs.
- 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
Real-time attendance is required for certificate of completion. Certificates are only available two weeks after the event.
- has been pre-approved by RAPS as eligible for up to 12 credits 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 0.25 non-GCP or non-GLP units 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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