ICH-GCP E6 R2 in Practice

Who should attend?

The course is relevant for professionals working in clinical research/ clinical operations, regulatory affairs and pharmacovigilance in pharmaceutical, biotechnology, CRORegulatory 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


Next offering to be confirmed


09.00 – 17.00 hrs


CTC office
Münchensteinerstrasse 41
CH-4052 Basel


Tram 15,
tram stop «Grosspeterstrasse»


Early Bird Fee: CHF 855.00 + 7.7% VAT
Regular Fee: CHF 950.00 + 7.7% VAT
10 % reduction for CTC employees and SwAPP members
The fee includes course documentation, refreshments, lunch and a course participation certificate

Cancellation Policy:

• Cancellations received more than 14 days before course: 100% refund less bank charges & cancellation fee of CHF 50.00
• Cancellations received 7-14 days before the course: 50% refund
• Cancellations received 7 days before the course: no refund

Training Terms & Conditions