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Mercure Hotel Amsterdam City

2019 年 12 月 02 日 9:00 上午 - 2019 年 12 月 03 日 6:00 下午

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Clinical Trial Regulation Conference

Status update, what we still need to know and the way forward

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概览

This conference will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes, including the new EU clinical trials Regulation but also conducting novel complex innovative design trials. Regulators and other decision-makers, together with various experts in the field, will debate how the new legislation will impact the processes for the design, submission and approval, and managing European clinical trials in the future.

精选主题

  • Status of the CTAs
  • Ethics Committee preparedness for CTR
  • Update on national pilots from MS
  • Innovative Trial Design and Management
  • GDPR and its consequences for Clinical Trials
  • Member States preparedness for the regulation, including plans for co-operation between agencies & ethics committees and coordinated assessment
  • Considerations for the preparation of applications and notifications by sponsors

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Exhibits

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谁应该参加？

  • 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

学习目标

  • 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 Trial Regulation
  • Exchange views between regulators, clinical trial sponsors, patients, and other stakeholders

项目委员会

  • Nick Sykes, MS
    Nick Sykes, MS Policy Advisor, Regulatory Strategy
    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
  • Vladimir Vujovic, MPHARM
    Vladimir Vujovic, MPHARM Director, Clinical Trials Regulatory
    IQVIA, Serbia

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