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Event Details


ICH GCP E6 R2 in Practice

ICH GCP E6 R2 in Practice

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Who should attend?

The course is relevant for professionals working in clinical research/ clinical operations, regulatory affairs and pharmacovigilance in pharmaceutical, biotechnology, CRO, Regulatory Authorities and study sites including investigator initiated studies involved in clinical trials. It will also be of interest to those departments who liaise / support clinical trial personnel such as clinical trial supply, quality assurance, document management, legal, and all other professionals who want to know more about the ICH GCP (R2) guideline.


Course Objectives

  • Understand the new requirements of the updated ICH GCP R2 guideline
  • Learn about further ICH GCP R2 changes
  • Discuss what inspectors are looking for with the new requirements
  • Review the new requirements for Sponsor Oversight, CROs, quality systems, risk based approaches and the TMF
  • Share best practice of these additional new GCP requirements

This course is interactive and gives you the chance to talk about your company’s needs and have your questions answered!


Early Bird Fee: CHF 855.00+ 7.7% VAT (valid until: 30.03.2018) Regular Fee: CHF 950.00 + 7.7% VAT (valid after: 30.03.2018) Please contact us for special group registration offer


Training Department

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