The Paediatric Regulation, an industry viewpoint based on experience from Novo Nordisk A/S - Vibeke Bjerregaard, Novo Nordisk A/S, Denmark

Session 2

The Paediatric Regulation, an industry viewpoint based on experience from Novo Nordisk A/S

Vibeke Bjerregaard, Novo Nordisk A/S, Denmark

Presentation followed by questions and answer session

• Outlining the development and regulatory plans
• The stages of development and the needs for details in the PIP
• The need for updates of the PIP
• Working with the PDCO

Questions:

• To what extent can PDCO request a development for a patient group not planned to be investigated in adults?
• How do we define indications and conditions?
• How is "significant therapeutic benefit" defined?