Mastering application of Good Clinical Practices (GCP)

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Objectives

  • Controling context, scope and requirements of Good Clinical Practices (GCP)

Audience concerned

Manufacturers/subcontractors in the healthcare sector:
– Regulatory affairs/quality managers
– Department Heads: Production, R&D
– Project Managers, software engineers

Aim

Acquiring the basics

Programme summary

  1. Introduction and objectives
  2. Ethics and protection of the subject
  3. Clinical research actors
  4. Vigilance
  5. Data Management
  6. Quality Management and monitoring
  7. Addendum of ICH E6
  8. Conclusion

Prerequisites

There is no prerequisite for this training.

Duration

1 day
7-hour classroom attendance

Inscription

Download the registration form

Date des formations CaduCeum Academy

Ref : CAGCP

Informations and registration : academy@caduceum.co.uk