Why Attend?
- Get the latest updates on innovative scientific methods and ongoing research efforts to address the challenges associated with the development of generic drug-device combination products.
- Bring your questions and have them answered by leaders in industry, academia, and FDA.
- Learn about the scientific considerations and associated challenges in demonstrating pharmaceutical equivalence for generic drug-device combination products.
- Join in scientific discussion on quality and manufacturing issues related to generic drug-device combination products.
Hot Topics
- Complex generic drug-device combination product regulation
- Product development, quality considerations, and demonstrating bioequivalence for generic complex products, such as inhalation and nasal products, injection devices, intravaginal rings and intrauterine systems, and topical and transdermal drug-device combination products
- Post-marketing pharmacovigilance and lifecycle management challenges
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