The EU Clinical Trial Directive

This two-day workshop will be of great value to clinical research professionals and those working with them involved in carrying out clinical trials. It is primarily designed to benefit the following disciplines:

• Clinical research and medical operations
• Researchers managing combined IMP’s/Medical Devices that also deliver Therapeutics (e.g. medicinal coated stents)
• Quality Assurance such as GCP Auditors
• Regulatory affairs
• Clinical trial supply
• Personnel at the study site
• CRO personnel
• All personnel who need to understand the impact of the EU Clinical Trials Directive

Learning Objectives

Upon completion of this course you will have a thorough knowledge of the EU Clinical Trial Directive requirements. The Directive, which took effect in May 2004, has changed the way firms must deal with Clinical Trial regulations. This content of this course is designed to provide the attendee with the latest information regarding the interpretation and enforcement of these regulations.

Course Description

This course focuses on understanding the requirements of the new EU Clinical Trial Directive and the issues inherent in any new regulatory process. The Course covers all relevant topics associated with the Directive, the reasons behind its introduction and a review of methods for effective implementation.

Key topics to be discussed:

• The current regulatory situation in relation to clinical trials in the E U.
• The purpose of the new Clinical Trials Directive.
• Meeting the New Requirements for Chemical Authorization and Conduct
• Understanding the impact the Directive will have on running clinical trials
• An overview of key areas of the Directive:
- Regulatory approval/notification
- Ethical review
- Exemptions under the current arrangements
- Informed consent
- Good manufacturing practice
- Safety reporting
- Inspection
• Gain a detailed explanation of the key differences between ICH GCP and the new EU Directive

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COURSE AGENDA

An overview of the Clinical Trial Directive

• Development, aims and planned implementation of the Clinical Trial Directive
• Update on the additional guidance documents relating to the directive
• The key areas of the Directive will be reviewed

Ethics Committees – the changing role

• What documents and issues must ethics committees now consider when they review clinical trials?
• What are the implications of the new time-lines for ethical review?

Informed Consent under the EU Directive – Extra protection for subjects

• How will informed consent be standardized?
• What extra protection is required for vulnerable groups such as minors and incapacitated adults?

Manufacturing and labeling of study drug – major changes for clinical trials

• The need to hold a manufacturing license
• What is the role of the qualified person?
• Handling importation of study drug from outside the EU

Safety – how does this compare with ICH requirements?

• Explanation of key differences between International Conference of Harmonization (ICH), Good Clinical Practice (GCP), and the new E U Directive.
• Reporting of adverse events and serious adverse reactions
• How does the Directive compare with existing requirements?

Inspection – implications for industry

• How will GCP and cGMP inspections be enforced?
• What is likely to be inspected?

Regulatory Approval and liaison with regulators

• Standardizing regulatory commencement of clinical trials in the EU
• A new European Database to compile a central register of information

Practical Sessions: Successfully Submitting Your Application to the Competent Authority
• Core information you need to supply
• What information to include in the cover letter
• Protocol
• Application forms
• Clinical / non-clinical data