9-10 September 2010
Berlin, Germany

This conference aims to educate attendees on best practices for ensuring maximum compliance and transparency while maximizing efficiency in clinical trial registration as well as registration of trial results. The conference will focus on directives put out by the EMEA, as well as discuss the multitude of requirements put forth by country run registries.

Featured presentations include:

THE EUROPEAN PROCESS
An overview of the clinical trial process, beginning with gaining approval for clinical trials in Europe, and how trials are registered with EudraCT
Detlef Niese, MD, PhD, Head, External Affairs, Global Development, NOVARTIS

THE CLINICAL TRIALS REGISTRY - INDIA (CTRI)
New mandatory registration: overcoming the hurdles and best practices for compliant registration with India’s clinical trials registry
Deven Parmar, Vice President, Clinical Research, WOCKHARDT

COMPLIANT GLOBAL REGISTRATION
Discussing the importance of ensuring compliance when registering in multiple countries and best practices to do so efficiently
Stephane Gilles, R&D IS - Project Management, SANOFI-AVENTIS

JOHNSON & JOHNSON CASE STUDY
Optimising internal processes using technology to improve efficiencies for clinical trial data disclosure
Erica F Schirmer, Global Operations Lead, Clinical Registry, JOHNSON & JOHNSON PHARMACEUTICALS RESEARCH & DEVELOPMENT

HL7 CLINICAL TRIAL REGISTRATION AND RESULTS PROJECT
Discussing the scope and progress of the HL7 CTR&R Project and evaluating the impact of standardisation
Monica Mehta, Director, Regulatory Affairs, GENZYME CORPORATION