2nd Annual Combination Product Regulation ConferenceJune 25-26, 2020 | Arlington, VA
Ensuring Compliance with US and International Regulations, including EU MDR, while Collaborating Across Drug-Device Industries to Develop Innovative Combination Products and Strengthen Robust Submissions to Speed Time-to-Market
Combination product teams are being faced with a multitude of regulatory requirements including FDA expectations, preparation for guidance documents currently in draft phase, and compliance with the up¬oming European Union Medical Device Regulation. In addition, teams developing combination products must work across industry divisions to co-develop the drug and device components simultaneously and ensure phases of R&D correspond. Leaders within the combination products industry will address a range of topics from conducting bridging studies, FDA jurisdiction and clarification on the appeal process, best practices to develop digital health and SaMD, and insight to develop successful regulatory submissions in challenging international markets. Providing a variety of interactive and engaging sessions including case studies, workshops, and panel, conference attendees will hear from regulatory experts as well as receive peer-to-peer interaction to collect critical take-aways on key industry topics.