Scientific Programme

EMA Symposium

A satellite symposium, co-organised with the European Medicines Agency, will take place on Thursday, 31 August, and Friday, 1 September 2017. Please find here preliminary information about the envisaged scientific sessions. More details can be found in the preliminary scientific programme.

Multiplicity issues in clinical trials: Recent update of the European guideline

Norbert Benda (Speaker), Michael Kunz (Speaker), Walter Offen (Speaker), Martin Posch (Speaker), Sylvia Schmidt (Speaker), Andreas Brandt (Chair), Frank Bretz (Chair)

Multi-Regional Clinical Trials

Bruce Binkowitz (Organiser), Vibeke Bjerregaard (Speaker, Panelist), Aaron Dane (Speaker, Panelist), Armin Koch (Speaker, Panelist), Claudia Schmoor (Speaker, Panelist), William Wang (Chair)

Matrix trial designs (incl. basket, umbrella, enrichment and other innovative designs)

Cong Chen (Organiser), Anja Schiel (Organiser, Chair), Ohad Amit (Speaker), Kristen Cunanan (Speaker), Frank Petavy (Speaker)

Interpretation of subgroup analysis in confirmatory clinical trials for regulatory decision making

Aaron Dane (Speaker, Panelist), Alex Dmitrienko (Speaker, Panelist), Armin Koch (Speaker, Panelist), Julien Tanniou (Speaker, Panelist), David Wright (Panelist), Christoph Muysers (Chair)

Biosimilar Drug Development: Statistical and Regulatory Issues

Franz König (Organiser), Thomas Lang (Speaker), Andrea Laslop (Speaker, Discussant), Johanna Mielke (Speaker), Byron Jones (Chair, Organiser)

Data Monitoring Committees – Scope, Expectations and Challenges for DMC Clinicians and Statisticians

Amit Bhattacharyya (Organiser), Adam Crisp (Panelist), Paul Gallo (Panelist), Lisa LaVange (Panelist), Geert Molenberghs (Panelist), Frank Pétavy (Panelist, tbc), Jonathan Seltzer (Panelist)

Qualifying Novel Methodology

Alun Bedding (Speaker), Efthymios Manolis (Speaker, tbc), Fabian Model (Speaker), Björn Bornkamp (Panelist), Hans Ulrich Burger (Chair), Stephan Lehr (Chair)

Estimands – A new framework for clinical trials

Christine Fletcher (Chair, Speaker, Panelist), Ann-Kristin Leuchs (Chair, Panelist), Thue Johansen (Speaker, Panelist), Steven Teerenstra (Speaker, Panelist), Mouna Akacha (Panelist), Hans Ulrich Burger (Panelist), Geert Molenberghs (Panelist)

Bridging the gap: the use of extrapolation in drug development and health technology assessment

Stuart Bailey (Speaker), Maxine Bennett (Speaker), Anja Schiel (Speaker)