Regulatory Education for Industry (REdI): Complex Generic Drug Product Development Workshop: September 12 & 13, 2018
Presentations
- Office of Generic Drugs Keynote (1of39) Complex Generics 2018
- Pre-ANDA Program Overview (2of39) Complex Generics 2018
- Pre-ANDA Logistics and Best Practices (3of39) Complex Generics 2018
- Pre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4of39) Complex Generics 2018
- Questions and Panel Discussion (5of39) Complex Generics 2018
- Peptide Drug Challenges through Pre-ANDA Processes & Case Studies (6of39) Complex Generics 2018
- Considerations in Demonstrating Complex API Sameness (7of39) Complex Generics 2018
- Common Issues in Complex Drug Substance Review (8of39) Complex Generics 2018
- Questions and Panel Discussion (9of39) Complex Generics 2018
- Considerations for Establishing Q1/Q2 Sameness of Complex Formulations (10of39) Complex Generics 2018
- In Vitro Release Testing of Complex Formulations (11of39) Complex Generics 2018
- Multivesicular Liposomes: Physicochemical characterization & in vitro drug release testing (12of39)
- Iron Colloid Drug Products: Characterization and Impurity (13of39) Complex Generics 2018
- Establishing Appropriate BE Limits for Complex Formulations (14of39) Complex Generics 2018
- Equivalence testing of complex particle size distribution profiles-earth mover’s distance (15of39)
- Questions and Panel Discussion (16of39) Complex Generics 2018
- In vitro bioequivalence testing for topical ophthalmic suspension products (17of39) Complex Generics
- Product Quality Testing for Topical Ophthalmic Suspension Products (18of39) Complex Generics 2018
- PBPK modeling and simulation used in assessing BE for generic ophthalmic products (19of39)
- Questions and Panel Discussion (20of39) Complex Generics 2018
- Overview of Current Science-Based Regulatory Standards (21of39) Complex Generics 2018
- Product Development Considerations for Generic Topical Products (22of39) Complex Generics 2018
- Common Deficiencies with ANDAs for Topical Products: (23of39) Complex Generics 2018
- PBPK Modeling for BE in Dermatological Products (24of39) Complex Generics 2018
- Panel Discussion- Delivery/Dosage Forms: Topical and Transdermal (25of39) Complex Generics 2018
- Product Dev Considerations for Generic Transdermal Delivery Systems (26of39) Complex Generics 2018
- Pre-ANDA Logistics and Best Practices (27of39) Complex Generics 2018
- Panel Discussion - Delivery/Dosage Forms: Topical and Transdermal (28of39) Complex Generics 2018
- Combination Products: User-interface & Role of Comparative Analyses (29of39) Complex Generics 2018
- In vitro and in vivo abuse deterrence evaluation of generic opioids (30of39) Complex Generics 2018
- Panel Discussion (31of39) Complex Generics 2018
- Guidances and FAQ for Orally Inhaled and Nasal Drug Products (32of39) Complex Generics 2018
- Common BE Deficiencies for Orally Inhaled Drug Products in ANDAs (33of39) Complex Generics 2018
- Common BE Deficiencies for Orally Inhaled Drug Products in ANDAs (34of39) Complex Generics 2018
- Quality Considerations for Generic Orally Inhaled Drug Products (35of39) Complex Generics 2018
- Batch-to-batch PK variability of orally inhaled drug products (36of39) Complex Generics 2018
- CFD modeling for product development of generic OINDPs and BE (37of39) Complex Generics 2018
- Panel Discussion Orally Inhaled and Nasal Drug Products (38of39) Complex Generics 2018
- Final Panel Discussion – All Topics (39of39) Complex Generics 2018
Who should attend? (attend in person or virtually)
Scientists, researchers, and regulatory affairs professionals who work on or are interested in working on the development of complex generic drugs.
Featured presentations include:
- Overview of Pre-ANDA Program for Complex Generic Drug Products
- Complex Active Pharmaceutical Ingredients (APIs)
- Complex Formulations/Dosage Forms
- Complex Route of Delivery: Ophthalmic
- Complex Routes of Delivery/Dosage Forms: Topical and Transdermal
- Complex Generic Drug-Device Combination Products and Complex Abuse Deterrent Formulations
- Complex Routes of Delivery: Orally Inhaled and Nasal Drug Products (OINDPs)