Clinical Trial Regulation and Guideline Requirements

1. Update of the EU Clinical Trial Directive

• Update on the implementation of the CT Directive and the framework of recently released documents

• What have been the main benefits and potential disadvantages of the Directive?

2. In-depth review of the EU Clinical Trials Directive

• A review of the EU Directive’s key areas

• Understand the differences between ICH GCP and the Directive

• Working to the Directive and “Applicable regulatory requirements”

3. What have been the main problems and challenges of working with the Clinical Trial Directive?

• A review of the CT Directive’s key issues and problems

• Group discussion of your concerns and queries, and to share experiences of practical solutions to meet the challenges of working to the Clinical Trial and GCP Directives

• Overcoming the problems – establishment of a Clinical Trials Facilitation group of Heads of Medicines Agencies

4. Brief Consideration of Global Impact of the EU Clinical Trial Directive so far

• Implementation in the 25 EU Member States – slides for information only

• Time-lines for ethical and regulatory review in different EU Member States

• Has there been a decrease in clinical research in Europe?

• How has the Directive impacted on the cost of clinical trials?

• Who have been most affected by the Directive?

5. In depth review and discussion of the GCP Directive (Workshop leader input and group review and discussion)

• Implementation of the GCP Directive and potential cost implications

• GCP - Which GCP standard? Link with the Declaration of Helsinki, ICH GCP, and the CT Directive

• IB – how do the requirements compare to ICH GCP?

• Manufacturing and import authorisations

• TMF and archiving - What should be filed, for how long and who should have access?

• Inspection process under the GCP Directive

• Non-commercial Guideline – what are the implications for pharma and non-commercial trialists? – key requirements

6. Brief understanding of the purpose of the EUDRACT Database

• How to apply for the sponsor study EUDRACT number

• How to use the EUDRACT database

• Who should have access to the database?

7. Ethics Committees guideline, and Ethical Considerations for Clinical Trials Performed in Children Guideline (Group review and discussion of the following areas in the revised EC implementation guideline and New guideline for trials in children)

• What have the problems and issues been with obtaining ethical approval under the new requirements?

• The role of the sponsor and investigators in completing the Ethics Committee applications

• Subject advertising

• Informed consent requirements

8. Brief Overview of the Clinical Trial Regulatory Authorisation and Amendments and IMPs vs NIMPs

• What information will be needed to go into the application

• Understanding the different types of amendments

• What is a substantial amendment?

• Ongoing and end of study reports

9. GMP Requirements and the Role of the Qualified Person (Group review and discussion of the GMP Directive, Annex 13, the Directive guideline defining what is an IMP, with input from the workshop leader)

• Ensuring GMP standards are met for clinical trials

• What is the role and the responsibilities of the QP for ensuring quality systems are in place for manufacturing?

• Annex 13 label requirements

• What documents will be needed for GMP aspects of clinical trials to comply with Annex 13, the GMP Directive and GCP Directive?

10. Brief Understanding of the Key Safety Reporting Requirements (Brief group review of the key definitions and requirements)

• What are the reporting requirements for SUSARs, adverse events and adverse reactions?

• Are the safety definitions consistent with ICH?

• What are the roles of the investigator and Sponsor for safety reporting?

11. Practical Advice for Preparing for Inspections and Understanding the Clinical Trial Directive

• Sharing Experiences from inspections carried out so far

• What are the new procedures for inspectors under the Directive?

• Practical advice on which specific SOPs/working procedures are needed to comply with inspection