2nd European Clinical Data Disclosure Summit

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FEATURED PRESENTATIONS

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
Speaker:
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
Speaker:
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
Speaker:
Stephane Gilles
R&D IS - Project Management
SANOFI-AVENTIS

JOHNSON & JOHNSON CASE STUDY
Optimizing Internal Processes Using Technology to Improve Efficiencies for Clinical Trial Data Disclosure
Speakers:
Erica F. Schirmer
Global Operations Lead, Clinical Registry
JOHNSON & JOHNSON PHARMACEUTICALS RESEARCH & DEVELOPMENT
&
Rob Middel
Director, Global Operations, Quality Management
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 Standardization
Speaker:
Monica Mehta
Director, Regulatory Affairs
GENZYME CORPORATION

Who should Attend

This Conference is specifically designed for Pharmaceutical, Biotechnology, Medical Device and Clinical Research companies with responsibilities in the following areas

  • Clinical Trial Registry/Registration/Results
  • Clinical Data Disclosure/Clinical Trial Disclosure
  • Regulatory Affairs/Compliance/Development/Policy/Intelligence
  • Clinical R&D/Clinical Research/Clinical Development
  • Medical Affairs
  • Medical Information/Knowledge Management
  • Clinical Trial Information
  • Clinical Trial Management
  • Clinical Operations
  • Statistics/Statistician – Biostatistics/Biostatistician
  • Clinical Quality Assurance
  • Clinical Intelligence
  • Clinical Data
  • Clinical Affairs
  • Biomedical Informatics
  • Medical Writing
  • Clinical Systems
  • R&D Operations/Compliance
  • Global Development Operations
  • Medical Communication


This Conference Is Also Of Interest To

  • Technology Vendors to Facilitate Data Management and Posting
  • Consultants
  • CROs with Registry Posting Services
  • Medical Translation Companies