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Fundamentals of Clinical Trials Regulations

Fundamentals of Clinical Trials Regulations

Adopt best practices and ensure a quick turnaround on clinical trial authorisation

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Course Highlights

  • Modules are released on a weekly basis

  • Learning with zero expense on travelling

  • PTI have partnered with EBD Group to offer highly specialized training for professionals involved in pharma/biotech partnering

  • Learning by just spending 2 hours/week

Duration: 28 Days

Mode of learning: Online Classroom

Course Overview

Who should do this course ?
  • This course is applicable to professionals involved, or interested in, clinical trials in the European Union

What are the course deliverables ?
  • Gain a well-rounded knowledge of Clinical Trial Regulations, from history to authorisation

  • Understand how to apply for a Clinical Trial Authorisation, and explore common challenges including substantial and non-substantial amendments and insurance considerations

  • Consolidate your knowledge using case study examples

  • Understand the importance of ICH GCP principles in running clinical trials

  • Familiarise yourself with the ethical considerations of a clinical trial, and learn how to apply for a clinical trial registration through EudraCT

More about this course
  • This course will take you through the history of clinical trial regulations, the new Clinical Trial Regulation and best practices for ensuring a timely clinical trial authorisation. You will explore important frameworks in clinical trial regulations, including: ICH GCP, Ethics Committee Application, Clinical Trials in Children and Adverse Events reporting

  • Delegates will be able to cement this knowledge through case studies highlighting the entire clinical trial process

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