Drug-Device Combination Products: Updates and Challenges with Demonstrating Generic Substitutability Date and Time: March 14, 2024 , 8:30 am – 6:00 pm , March 15, 2024 , 8:30 am – 4:40 pm

https://www.complexgenerics.org/education-training/drug-device-combination-products-updates-and-challenges-with-demonstrating-generic-substitutability/?utm_medium=email&utm_source=govdelivery This 2-day hybrid (virtual and in-person) workshop is focused on addressing current challenges associated with developing complex generic drug-device combination products (DDCPs). This workshop is primarily for the generic drug industry and other collaborators involved with generic DDCP development and assessment, including human factors consultants and contract research organizations. This workshop will be held virtually and in-person at The Universities at Shady Grove, Rockville, MD. Virtual Attendance is optimal for an audience interested in conveniently receiving helpful advice and practical information on the current thinking and best practices related to developing complex generic DDCPs. Virtual attendees will enjoy free access to all symposia, except Symposium III, including opportunities to: Attend all presentations and panel discussions, including a dedicated “Ask the FDA” session Submit live questions online for discussion panel Q&As Enjoy free access to workshop recordings of presentations and panel discussions (not including the in-person working sessions in Symposium III: Setting the Course for the DDCP Future) In-Person Attendance is optimal for an audience interested in actively engaging with FDA and industry colleagues to discuss complex issues, resolve current problems, provide insights, detail industry experience about implementation challenges and discuss alternative approaches to comparative user interface assessment. In-person attendees will also play an active role in conversations related to the future direction of this field during Symposium III by: Participating in working sessions on four challenging aspects of comparative user interface assessment Collaborating with FDA and industry thought leaders to define knowledge gaps, resource needs, and next steps Informing a “roadmap” for a CRCG working committee that will collaborate with FDA to plan and prioritize next steps and formulate research questions to address and bridge the gaps in comparative user interface assessment Conversing with panelists during discussion panel Q&As, including a dedicated “Ask the FDA” session Networking with colleagues during breaks with light snacks and beverages, and catered lunches For more information, please visit https://www.complexgenerics.org/education-training/drug-device-combination-products-updates-and-challenges-with-demonstrating-generic-substitutability/.