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.
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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.
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- Participate in live session polling
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Nick Sykes, MS Senior Director, Global Regulatory Affairs
Pfizer Inc, United Kingdom
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
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