Clinical Trial Regulation Conference

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

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Exhibits

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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 impact of the new requirements on running clinical trials in Europe along with the practical and operational considerations for implementation by authorities and clinical trial sponsors
• Identify the opportunities and consider how to overcome the key challenges of the requirements particularly for novel clinical trial approaches
• 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 and other decision-makers, clinical trial sponsors, patients, and other stakeholders

Program Committee

Nick Sykes, MS • Senior Director, Global Regulatory Affairs
Pfizer Inc, United Kingdom
Elke Stahl, PhD • Senior Expert, Clinical Trials Department
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Rose-Marie Swallow • Senior Manager, Policy & Research
Bayer Plc., United Kingdom