While publication of the Clinical Trial Database is delayed, the endorsement of the Clinical Trial Regulation is moving forward in other areas. The Clinical Trial Regulation Conference will focus on the differences between, the present and new requirements on managing clinical trials in the face of forthcoming changes.
This 2-day 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 as they consider changes needed to implement the regulation?
- 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.
Who should attend?
This conference is aimed at intermediate and experienced professionals from:
- Regulatory agencies
- The pharmaceutical industry and contract research organisations, including:
- Staff from clinical science and clinical operations
- Monitors, auditors of clinical trials
- Regulatory affairs personnel
- Pharmacovigilance staff
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