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.
Experience the Conference on the go with the DIA Global App
DIA is going green: what about you?
In 2018, DIA is going paperless. No printed programme will be distributed onsite, so please make sure to download the app in advance.
The DIA Global App is designed to enhance your meeting experience and provide valuable information in one place. Search "DIA Global" in your app store.
- View agenda and speakers
- Connect and network with attendees and exhibitors
- Participate in live session polling
- Participate in live activity feed with real-time updates
- Integrate with your social media accounts
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
- 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
Nick Sykes, MS • Senior Director, Worldwide Safety & Regulatory
Pfizer Ltd., United Kingdom
Surendra Gokhale, DrSc, PhD • Senior Director, Global Regulatory Affairs and Capability Development Lead
F. Hoffmann-La Roche Ltd, Switzerland
Elke Stahl, PhD • CTFG Co-Chair; Clinical Trial Unit
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Rose-Marie Swallow • Senior Manager, EU Regulatory Policy & Intelligence
Bayer Plc., United Kingdom