This presentation will give an overview over EU regulatory landscape, legal framework, and how to accelerate product development in order to get promising medicines to patients faster. There are a few approaches from regulatory agencies, i.e. the PRIME scheme in the centralised approval process at the EMA, but most of the acceleration efforts need to come from companies. An adequate, state of the art regulatory strategy is essential to gain a competitive advantage and get medicines to patients faster.
- The EU regulatory landscape / why regulate medicines?
- Novel ways for drug development and the regulatory strategy behind them – How to get medicines to patients faster?
- Artificial intelligence to aid in product development – The use for regulatory strategy and acceleration
- Early Collaboration with Market Access – How to work hand in hand to overcome access and reimbursement hurdles already during the drug development process
- Regulatory affairs as a driver for competitive advantage and fast-to-market strategies