This Statistics Workshop is jointly organised by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) and the Drug Information Association (DIA) and will be held in Barcelona, Spain at the Tryp Barcelona Apolo Hotel on November 10 – 11, 2014.
Lifecycle management is a widely accepted concept for development and marketing of medicines. At each step of this process, pre– and post-licensing, statisticians work to develop methods that can improve efficiency and can enhance decision making through optimal study design, analysis and inference.
The meeting aims to discuss the latest developments in statistical methodology and decision making in exploratory development, confirmatory development, licensing decisions and management of benefits and risks post-licensing. The discussions will consider not only the methods themselves, but how best to integrate methods for use in a regulatory context. Beyond this, the meeting seeks to ask whether there are advances in the collection and understanding of real world data that can inform and improve the design of confirmatory clinical trials.
- Latest news on emerging regulatory guidance documents for clinical trial methodology
- Clinical Trial Transparency – practical challenges ahead for statisticians
- 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
- Therapeutic area special; a focus on biological medicines
- Clinical Practice Research Datalink tutorial
- Incorporating real world data into drug development, licensing, re-imbursement and prescribing
- Risk-based monitoring
- Increasing the breadth of sponsor /regulator interactions on methodology
Who Should Attend
Professionals with an interest in the application of, and research into, statistics in the drug development process from the pharmaceutical industry, academia, regulatory and governmental agencies, as well as contract research organisations.
DIA meetings and training courses are generally approved by the Commission for Professional Development (CPD) of the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society of Pharmaceutical Medicine (SGPM) and will be honoured with credits for pharmaceutical medicine. All participants are eligible for these credits and certificates are available.
- Ferran Torres – Scientific Director, Biostatistics and Data Management Core Facility, IDIBAPS – Hospital Clinic of Barcelona. Associate Professor, Biostatistics Unit, Faculty of Medicine, Autonomous University of Barcelona. AEMPS Statistical Consultant. Spain
- Beatriz Seoane – Expert Statistician, Clinical Statistics Department, Almirall, Spain
- Michael Branson – Global Head Full Development Biostatistics, Oncology Business Unit, Novartis Pharma AG, Switzerland
- Norbert Benda – Head of Biostatistics and Special Pharmacokinetics, Federal Institute for Drugs and Medical Devices (BfArM), Germany
- Hans-Ulrich Burger – Senior Director of Biostatistics, F. Hoffmann-La Roche AG, Switzerland
- William Malbecq – Executive Director Biostatistics, MSD Europe, Brussels, Belgium
- Tim Friede – Professor of Biostatistics, Chair, Department of Medical Statistics, University Medical Centre Göttingen, Germany
- Geert Verbeke – Professor of Biostatistics, Department of Public Health and Primary Care, KU Leuven, Belgium