Clinical Trial Regulation Conference

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

参加申し込み

概要

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.

特集トピック

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

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

学習目的

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

プログラム委員会

Nick Sykes, MS Policy Advisor, Regulatory Strategy
EFPIA, Belgium
Surendra Gokhale, DrSc, PhD Senior Director, Global Regulatory Affairs and Capability Development Lead
F. Hoffmann-La Roche Ltd, Switzerland
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
Vladimir Vujovic, MPharm Director, Clinical Trials Regulatory
IQVIA, Serbia