An overview of the drug development process from discovery to clinical development. Key questions will be addressed on:
• Data and documentation needed for entering the clinical development stage’
• Requirements to non-clinical and CMC towards a market authorization
• Contents of the clinical program and exemplified challenges including drug-device development
A detailed and practical overview of the CMC, clinical and regulatory activities will be included in the talk.
Michael Gerstenberg, Project Director at KLIFO. Michael has 20 years of drug and device research and development experience from Novo Nordisk and supporting biotech and medtech companies at KLIFO.