Clinical Trial Regulatory Guideline Requirements 2016

  • 09-10 Jun 2016
  • The Rembrandt Hotel, London, United Kingdom

Description

Clinical Trial Regulatory Guideline Requirements 2016 covers topics such as:

  • The New EU Clinical Trial Regulation and How this will Replace the EU Clinical Trials Directive in 2016
  • Understand the Current Framework of Clinical Trial Regulations in Europe
  • Ethics Committee (EC) Submissions and Approval
  • Clinical Trials Authorisation: Regulatory Approval and Ethical Approval
  • Brief Overview of Legal Aspects of Clinical Trials
  • Running Clinical Trials in Children: The Paediatric Plan and Ethical Considerations
  • Pharmacovigilance and Adverse Event Reporting
  • Investigational Medicinal Product
  • Brief Considerations for Preparing for Regulatory Inspection
  • Brief Overview of other Recent EU and FDA Developments in Clinical Trial Requirements including:

Clinical Trial Regulatory Guideline Requirements 2016 brings together:

  • Clinical research
  • Working in regulatory
  • Project management
  • Clinical operations
  • Vendor/CRO professionals
  • Quality assurance (GCP auditors)

Past Events

Important

Please, check "Clinical Trial Regulatory Guideline Requirements" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Innovations, Marketing & Sales, Operations
Education: Education Technologies & Methods, Higher education, Training
Health & Medicine: Medical device, Medical laboratories
Science: Life Sciences & Biology

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