This session will guide you through the complexity of developing drug-device combinations products and provide you with basic tips.
Before vaccines make it to the clinic, called pre-clinical development, it is often a lengthy, challenging and cost-intensive process. Very often, hard choices must be made between never-ending original ideas to make the product “better”, feasibility, available investments, timelines not to forget production requirements, anticipation regulatory requirements and market needs. The better this pre-clinical phase is planned, the better the chances all data generated during this phase can be used in the final dossier and do not have to be redone, sometimes from scratch, for quality and regulatory requirements.
During the session, you will go through this process with examples lived by the trainer. He will use the COVID vaccine developments and other vaccine developments as examples.