Regulatory Strategies to Derisk Novel Combination Product Development

Session details:

As regulators clarify expectations and requirements around reliability, human factors, needle safety, etc, it is paramount for companies to build robust evidence packages that support approval. This panel will focus on strategies to reduce risk and expedite development timelines by aligning early with regulatory agencies, defining clear pathways and integrating device and drug requirements effectively. Panelists will also address how regulatory and development colleagues can collaborate to advance platform approaches.