ICH-GCP E6 R2 in Practice - 20 April 2018

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

Date:

This course is fully booked. The next course is running on 21st September

Time:

09.00 – 17.00 hrs

Venue:

CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Directions:

Tram 15,
tram stop «Grosspeterstrasse»

Fee:

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)
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

Document:

ICH GCP E6 R2_flyer.pdf