ICH-GCP Update - An Auditor's Perspective - 21 September 2018

Who should attend?

This course is designed for those with experience in clinical research requiring information on how to prepare for GCP inspections and for those seeking to update their knowledge on the changes to the ICH-GCP Guideline E6 R2. It is aimed at Clinical Research Assistants/Coordinators, Clinical Trial/Project Managers, Clinical Research Physicians, Study Data Managers, Monitors, those working in Clinical Quality and Compliance, and will also be of interest to those in related functions (Clinical Science, Drug Supply, Drug Safety, Regulatory).

Course Objectives

The course offers a thorough update of the current understanding and interpretation of Good Clinical Practice and practical guidance/advice on how to ensure readiness for Health Authority inspections, both of Sponsor and Investigator sites. With this course you will:

  • Refresh knowledge of ICH-GCP, particularly from the Sponsor perspective including the changes to ICH-GCP E6 R2
  • Become familiar and discuss current "hot topics" in the Clinical Development environment
  • Learn practical steps in preparing for Sponsor and Investigator site inspections
  • Participate in interactive workshop exercises to improve course retention

Date:

21 September 2018

Time:

08.30 – 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: 10.08.2018)
Regular Fee: CHF 950.00 + 7.7% VAT* (valid after: 10.08.2018)
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 Update_Flyer.pdf