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Hilton London Docklands Riverside Hotel

Sep 17, 2018 8:00 AM - Sep 18, 2018 12:40 PM

265 Rotherhithe Street , London, SE16 5HW, United Kingdom

Clinical Trials Regulations Conference


While the implementation date of the Clinical Trial Database is delayed, work is progressing on the implementation of the Clinical Trial Regulation in other areas. The Clinical Trials Conference will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes.                                                                                                                 

This conference will provide a forum for information exchange on both conceptual and practical questions of:

  • How will the new legislation change the processes and the format of the trial application?
  • What are the impacts on how a clinical trial is managed after approval has been granted?
  • What are the critical issues affecting sponsors and Member States
  • How will the new provisions for public access to an EU Clinical Trials Database enforce disclosure of clinical trial data and information?

Attendees will participate in the collaborative discussions through lectures, panel discussions and interactive sessions.

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Who should attend?

  • Regulatory agencies (assessors, reviewers, inspectors)
  • Sponsors of non-commercial clinical trials
  • The pharmaceutical industry and contract research organisations, including:
    • Regulatory affairs personnel in clinical research
    • Professionals in charge of clinical trial strategy
    • Regulatory intelligence and policy professionals
    • Change managers for clinical trials business processes
    • Clinical research professionals working with submission, data, information sharing
    • Clinical safety professionals

Learning objectives

  • Understand the new requirements along with the practical and operational considerations for implementation by authorities and clinical trial sponsors
  • Identify the key challenges and opportunities of the new requirements and policies
  • Leverage insights on how companies and research institutions are fine-tuning and optimising processes to meet the requirements of the Clinical Trials Regulation
  • Exchange views between regulators, clinical trial sponsors, patients, and other stakeholders

Program Committee

  • Nick  Sykes, MS
    Nick Sykes, MS Policy Advisor
    EFPIA, Belgium
  • Surendra  Gokhale, DrSc, PhD
    Surendra Gokhale, DrSc, PhD Senior Director, Global Regulatory Affairs and Capability Development Lead
    F. Hoffmann-La Roche Ltd, Switzerland
  • Elke  Stahl, PhD
    Elke Stahl, PhD Senior Expert, Clinical Trials Department
    Federal Institute For Drugs and Medical Devices (BfArM), Germany
  • Rose-Marie  Swallow
    Rose-Marie Swallow Senior Manager, Policy & Research
    Bayer Plc., United Kingdom

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