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Clinical Data, Clinical Operations and Statistics are highly dynamic groups in the clinical development arena.

In three parallel themes, Data Management, Clinical Operations and Statistics will be examined through presentation, case studies and discussion focusing on how to achieve operational excellence. During a joint plenary session, topics that bind both groups will be discussed: Risk-based Monitoring, the status of eSource and independent 3rd parties, and Quality Management in Outsourcing.

This year will also be bringing important changes in the European regulatory framework once the ICH E6 Addendum kicks in. Be prepared!

Problem Solving Sessions - Share Solutions and Challenges
The Clinical Forum is piloting a new type of interactive session. We want to offer you the opportunity to bring your challenges/business pains in implementation to the conference and discuss with your peers and assigned experts how to best resolve them:

  • More Pharma or Biotech companies are subcontracting full service CROs. What does this third party outsourcing mean for CROs and for oversight by pharma/biotechs and which challenges are you facing? (Will be discussed in Session 1)
  • With the adoption of ICH E6 (R2) - the Addendum to CGP - RBQM in Clinical Development is no longer optional. Which challenges are you facing during the implementation of RBQM into the clinical quality management system. (Will be discussed in Session 4)
Submit your Case

Featured topics

  • Incorporate Risk-Based Quality Management in Your Organization with Excellence
  • e-Solutions (eSource, e-Trial Master File, Cloud Solutions, e-Health)
  • End-To-End Data Integrity: Data Quality and Data Integrity
  • Inspections and E-Solutions: Case Studies on Regional Differences
  • How Risk-Based Monitoring Binds all Stakeholders - Data Managers, Statisticians, Monitors, Investigators and Inspectors
  • How Patient Socialisation Affect Clinical Trials
  • Managing Outsourced Studies: How to Prevent Fragmentation?
  • Impact of Local Cultures and Working Environments on Global Pharma Processes
  • Data Sharing and Clinical Statistics

Who should attend?

  • Professional working with clinical operations
  • Clinical data management professionals
  • Monitors
  • Statisticians
  • Inspectors
  • Process optimization leads and managers
  • Trial managers
  • Field monitors
  • Site representetatives, Site leads
  • Project data managers
  • Professionals working in the interface between CROs and Sponsors
  • Vendor managers
  • Pharma IT professionals (working in highly regulated environment)

Learning objectives

  • Prepare for the changes brought by Clinical Trial Regulations and ICH E6 Addendum
  • Exchange views and experiences with peers and other stakeholders
  • Discuss the future aspects of clinical research and need for tools and skills
  • Bring together people working in different interfaces to shape and improve practices

Program Committee

  • Rolf Peter Banholzer, PhD
    Rolf Peter Banholzer, PhD Global Head GxP IT Systems & Processes
    Novartis Pharma AG, Switzerland
  • Hans Ulrich  Burger, PhD
    Hans Ulrich Burger, PhD Senior Director of Biostatistics
    F. Hoffmann-La Roche Ltd., Switzerland
  • Estrella  Garcia, PhD
    Estrella Garcia, PhD Head of Global Clinical Operations
    Almirall S.A., Spain
  • Julianne  Hull, MS
    Julianne Hull, MS CEO
    WenStar Enterprises, United Kingdom
  • Mette  Mackeprang Bruhn, MA
    Mette Mackeprang Bruhn, MA Team Leader
    Novo Nordisk A/S, Denmark
  • Heike  Schoen, MBA, MSc
    Heike Schoen, MBA, MSc Managing Director
    LUMIS International GmbH, Germany
  • Peter  Stokman, MSc
    Peter Stokman, MSc Sr Expert Data Manager
    Bayer, Netherlands
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+41 61 225 51 51

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