Good Clinical Practice GCP Course and GCP Auditing by Institute of Clinical Research-UK

Posted by - Posted in Friday, 31 December 2010

The Institute of Clinical Research is delighted to annouce their intended activity during January 2010.

ICR is Britich organization with global focus on clinical research development and training. For more details about ICR please visit www.icr-global.org.  During 8-11 January 2011, GCP Course and GCP Auditing course is planned to take place in Cairo. To book your seat kindly call Dr Sherif Akl on +20113449964 (Egypt)

The course is composed of 2 parts:

Part 1: Good Clinical Practice

Course summary

This course provides an overview of the regulatory systems currently in operation in the EU and an understanding of the rationale for those systems.  Starting with the history of medicinal product regulations and the need for ethics, the course explains the regulatory aspects of clinical development and the purpose and impact of the EU regulations on the conduct of clinical research. Practical Applications of GCP are explored including Informed Consent and Safety Reporting.

You will receive a complementary copy of the ICH GCP guidelines.

Who will benefit?

All those involved in Clinical Research.

Course outline

  • The History of GCP and the evolution of the pharmaceutical industry
  • The Phases of Drug Development
  • ICH GCP and the impact of EU Directives
  • Implementation in the UK
  • Roles and responsibilities of Clinical Trial Personnel
  • Ethics Committees and Competent Authorities
  • Clinical Trial Authorisations
  • Life cycle of a clinical trial
  • The protocol and case report form
  • Essential Documentation
  • Data Flow and Data Integrity
  • Audits and Inspections
  • Marketing Authority Applications
  • The marketing and selling of medicinal products
  • Practical Aspects of GCP
  • Informed Consent
  • Safety Reporting

Part 2: Good Clinical Practice

Course summary

This course enables delegates to develop an effective strategy to plan and prepare efficiently for an audit/inspection through understanding the process and procedures.  Delegates will recognise and prioritise methodologies to enable them to prepare for a successful audit/inspection and identify key stakeholders in the process. The course will explore how to reduce the anxiety of audits/ inspections by having an effective strategy to be ‘audit ready’.

Who will benefit?

This course will be of benefit to all clinical research personnel who are likely to be involved, at any stage, in an audit or inspection.

Course outline

  • What constitutes an audit /inspection?
  • What will be audited/inspected
  • QA, checking, QC and Monitoring
  • Preparation and organisation for an audit
  • Be a company that is audit ready
  • Trial Master File
  • Audit Trails and File Notes
  • What will happen on the day?
  • Introductory Meeting
  • Interviews and questions
  • The exit meeting
  • Responding to audit/inspection findings
  • What can go wrong and what will go well
  • Lessons learned

To book your seat kindly call Dr Sherif Akl on +20113449964 (Egypt)

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