Design of Clinical Trials – Regulatory, Statistical and Medical Aspects
Haga Forum, September 28th
A non-technical approach for medical managers, clinical project leaders, regulatory personel, medical liaison officers, statisticians.
From 9.00 Registration and coffee
10.00 Welcome and introduction -Anna Törner, Managing Director SDS
10.15 The Importance of Regulatory Strategies for Design of Clinical Trials
– Åsa Holmgren, MSc.Pharm. Sr Vice President Regulatory Affairs and Alliance Management, Orexo AB. Former, Senior Global Regulatory
Affairs Director with AstraZeneca.
11.00 Novel Approaches to Design and Analysis of Clincial Trials
– Kevin J Carroll, PhD, CStat, CSci, Hon Snr Lecturer. KJC Statistics Ltd. Former Chief Statistician, AstraZeneca Development.
11.50 Clinical Trial Simulation for Decision-Making – A Practical Introduction for the Non-Statistician
– Andrew Hooker, PhD. Ass. Prof. Dept. of Pharmaceutical Biosciences, Uppsala University, Advisor, Pharmetheus AB.
13.45 Regulatory Aspects on Adaptive Designs
– Prof. Eva Skovlund, NTNU, former CHMP delegate and chair Biostatistical Working Party, EMA.
14.45 Trends in Clinical Trial Design From an Investor’s Perspective
– Johan Christensson, MD. PhD, Partner HealthCap.
16.00 Panel Discussion – ”Advanced Trial Designs – Possibilities and Challenges”
– Bertil Jonsson, Eva Skovlund, Åsa Holmgren, Johan Christensson
You are welcome to register at HagaForum2015@scanddev.se
Cost 1500 SEK + tax (non-service provider)