Joint DIA/AEMPS Statistics Workshop 2014

Joint DIA/AEMPS Statistics Workshop 2014 is a workshop focused on

• Clinical Trial Transparency – practical challenges ahead for statisticians
• Therapeutic area special - a focus on biological medicines
• Risk-based monitoring Increasing the breadth of sponsor / regulator interactions on methodology
• Datalink tutorial Incorporating real world data into drug development, licensing, re-imbursement and prescribing
• Clinical Practice Research
• Latest news on emerging regulatory guidance documents for clinical trial methodology
• Harmonising sponsor and regulator decision-making across the life-cycle, from dose-finding through benefit-risk and beyond; understanding hurdles and optimising methods with a focus on Bayesian Statistics and quantitative Benefit Risk

Who should Attend

Professionals from the academia, pharmaceutical industry, contract research organisations, regulatory and governmental agencies.