Fundamentals of Clinical Research & GCP - Denmark

Fundamentals of Clinical Research & GCP - Denmark
Product Code: Fundamentals of Clinical Research & GCP - Denmark
Availability: In Stock
Price: £500.00

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This 1-day course is a plain language guide to product development, clinical trial methodology and terminology and essentials of GCP.

No prior knowledge or experience is required.
This course is ideal for new personnel, those in non-technical roles requiring basic knowledge of clinical trials and GCP responsibilities, administrators, members of non-clinical departments in commercial companies and members of ethics committees. The course is the first day of our Foundation in Clinical Research course.

Objectives and Course Content

At the end of the course participants should have a good understanding of the clinical trial process, be aware of the need to comply with GCP and be aware of the most important GCP responsibilities.
The course will inform participants about......

  • the development of a new medicinal product through the various phases of clinical research
  • the types of study undertaken (human pharmacology, therapeutic exploratory, therapeutic confirmatory, therapeutic use; Phases I to IV and PMS)
  • abbreviations, methodology and terminology in a plain understandable language including study designs (parallel group/crossover), blinding methods, use of placebo and other controls
  • introduction to good clinical practice (GCP) — history, development, principles and basics
  • Impact of national laws and critical European Directives/Regulations
  • GCP implementation and standard operating procedures
  • the ICH process and its products
  • step by step to a clinical trial: the processes involved in setting up a clinical trial from planning to final report including GCP requirements at each stage
  • essential clinical trial documents

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