AN ESSENTIAL GUIDE
TO CLINICAL TRIAL
REGULATIONS

Conference Date: 20-21 May 2010
Conference Ref: A5-4110
Fee: £1225 + VAT
Venue: The Rembrandt Hotel, London

Benefits of Attending:

• Decipher the framework of Clinical Trial Regulations in Europe
• Discuss the European Commission Assessment of the Clinical Trial Directive Consultative process
• What could be changed in a Review of the Directive?
• Gain an Overview of the EU Clinical Trial Directive and GCP Directive and some of the key issues
• Discuss Clinical Trials Authorisations: Regulatory Approval and Ethical Approval
• What are the Implications of Running clinical trials in Children: The Paediatric Plan and Ethical considerations
• Understand the Legal Aspects of Clinical Trials
• Ensure you Comply with Pharmacovigilance & Adverse Event Reporting
• Discuss Clinical Trial Data Management including EDC and e-source
• Understand FDA requirements
• What you need to know about Regulatory Inspections

Who Should Attend

The course is relevant for anyone involved with clinical trials or liaising/supporting Clinical research professionals in pharmaceutical, biotechnology CRO and SMO –companies, or study sites including investigator initiated studies.

The workshop will also be of interest to those departments who liaise with clinical trial personnel (such as regulatory affairs, clinical trial supply, quality assurance, document management, legal, regulatory authorities, and all other professionals who want to know more about regulations covering clinical trials.)

With
Dr Laura Brown Independent QA expert and Training Consultant in the Pharmaceutical Industry & Director of the MSc in Clinical Research, School of Pharmacy, University of Cardiff, UK

Click here to book your place.