Veterinary Drug Approvals: Practical Considerations for Conducting FDA-Required Regulated Studies 2015

  • 08-09 Oct 2015
  • SpringHill Suites by Marriott Orlando Lake Buena Vista in Marriott Village, FL, United States

Description

Topics
  • The similarities and differences between GCP and GLP and their application to trial types
  • The concepts of VICH GCP
  • Target Animal Safety studies and the structure and requirements of margin of safety studies
  • How GLPs can be implemented
  • The differences between quality audit procedures and quality assurance procedures
  • How to write good clinical trials protocols
  • Identify the attributes of valid data and gain tools to review electronic and hard copy data to assess data integrity and fraud
  • The concepts of clinical trial monitoring
  • How to handle an FDA inspection
Who should Attend
  • Human pharmaceutical professionals interested in veterinary trials
  • Individuals involved in academia interested in veterinary trials
  • Clinical trial managers
  • Veterinarians interested in regulated research
  • Quality assurance professionals
  • Product development professionals
  • Professionals seeking VICH GCP refresher training
  • Regulatory professionals
  • Contract research organization personnel

Past Events

Important

Please, check "Veterinary Drug Approvals: Practical Considerations for Conducting FDA-Required Regulated Studies" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Pharma
Industry: Agriculture
Science: Life Sciences & Biology

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