Tuesday, May 12

• The regulatory affairs role – a strategic partner

• Global regulatory strategies

• Global filing strategies

• Acceleration pathways

• Case study

• Paediatrics

• Orphan drugs

Wednesday, May 13

• Regulatory and business intelligence

• Scientific advice

• Patent and exclusivity – what is the difference?

• CMC considerations for successful outcome of global regulatory strategies

• Strategies optimizing life cycle management

• Health Technology Assessment from a regulatory perspective