1. Practical Implementation of E5 Guidelines: Regional Trials
D Doogan

2. Access to new Medicines the Major Benefit
Regional/Global Trials will have a profound impact
Need to develop guidelines for composition of national and regional contributions

3. Bridging of Data The Key to Globalisation
National Regional Global Data Sets
Need to ensure signals map between locations
Critical questions
Comparison of benefit-risk
Scientific underpinning of impact of extrinsic factors
Balance of influence of intrinsic and extrinsic factors