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Overview

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.

Featured topics

  • 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

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

Program Committee

  • Nick  Sykes, MS
    Nick Sykes, MS Senior Director, Worldwide Safety & Regulatory
    Pfizer Ltd., United Kingdom
  • 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 CTFG Co-Chair; Clinical Trial Unit
    Federal Institute For Drugs and Medical Devices (BfArM), Germany
  • Rose-Marie  Swallow
    Rose-Marie Swallow Senior Manager, EU Regulatory Policy & Intelligence
    Bayer Plc., United Kingdom
  • Vladimir  Vujovic, MPharm
    Vladimir Vujovic, MPharm Regulatory and Safety Manager
    Optimapharm, Serbia
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